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# Data Set Module Design (V3.3) 2.16.840.1.113883.3.1937.777.64.1.6

Name | Id
--- | ---
Module Design (V3.3) | 2.16.840.1.113883.3.1937.777.64.1.6
Version / effective date | Expiration date
2024‑03‑06 09:22:58 |
Description
NFDI4Health Resource Design Metadata Schema V3.3
Relationship |
Version | Core Medata Schema (nfdhtfcov19-dataset-2 - 2022‑11‑28)
Version | Module Design (V3.3) (nfdhtfcov19-dataset-2 - 2023‑12‑04)
Name | Details [‑] |
--- | --- | ---
Design nfdhtfcov19-dataelement-155 | link
Id | nfdhtfcov19-dataelement-155 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Characteristics of the [RESOURCE]
### Properties
Design | Design
Relationship | Specialization studyDesign ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the characteristics of a [RESOURCE].
Source | NFDI4Health
Comment | Additional information: Group of items applicable only to studies, substudies, registries, and secondary data sources.
Comment | Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy' OR 'Registry' OR 'Secondary data source'); otherwise 0..0
Comment | Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230' OR 'C61393' OR '178'); otherwise 0..0
primaryDesign nfdhtfcov19-dataelement-156 |
Id | nfdhtfcov19-dataelement-156 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Is it an interventional or non-interventional [RESOURCE]?
### Properties
Design.primaryDesign | Design.primaryDesign
Relationship | Specialization primaryDesign ( - 2022‑11‑28)
Rationale | Description: Non-interventional design refers to a [RESOURCE] that does not aim to alter its outcomes of interest. Interventional design refers to a [RESOURCE] that aims to alter its outcomes of interest.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Operationalization | Short input help: Select between non-interventional and interventional design for the given [RESOURCE].
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Non-interventional | (1) A study that does not aim to alter study outcomes of interest; (2) A study in which the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C142615" (Non-Interventional Study) from code system "FDA RouteOfAdministration"
Interventional | (1) A study that aims to alter study outcomes of interest; (2) Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C98388" (Interventional Study) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Primary_Design_NCI (version 2024‑01‑18 13:22:47)
studyType nfdhtfcov19-dataelement-157 | link
Id | nfdhtfcov19-dataelement-157 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Specification of the type of the [RESOURCE]
### Properties
Design.studyType | Design.studyType
Relationship | Specialization studyType ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the type of the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] DDI [ https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html] MIABIS [ https://github.com/BBMRI-ERIC/miabis]
Comment | Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
interventional nfdhtfcov19-dataelement-158 |
Id | nfdhtfcov19-dataelement-158 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Interventional [RESOURCE] type
### Properties
Design.studyType.interventional | Design.studyType.interventional
Relationship | Specialization interventional ( - 2022‑11‑28)
Rationale | Description: The strategy for assigning interventions to participants.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..*, if Design.primaryDesign == 'Interventional'; otherwise 0..0
Comment | Cardinality: 1..*, if Design.primaryDesign == 'C98388'; otherwise 0..0
Operationalization | Short input help: Select all that apply. If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Single group | Clinical trials with a single arm [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C82640" (Single Group Study) from code system "FDA RouteOfAdministration"
Parallel | Participants are assigned to one of two or more groups in parallel for the duration of the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C82639" (Parallel Study) from code system "FDA RouteOfAdministration"
Crossover | Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C82637" (Crossover Study) from code system "FDA RouteOfAdministration"
Factorial | Two or more interventions, each alone and in combination, are evaluated in parallel against a control group [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C82638" (Factorial Study) from code system "FDA RouteOfAdministration"
Sequential | Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C49153" (Sequential) from code system "FDA RouteOfAdministration"
Other | A study type that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Unknown | The study type is unknown [NFDI4Health]. | code "C17998" (Unknown) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Type_Interventional_NCI (version 2024‑01‑18 20:23:27)
nonInterventional nfdhtfcov19-dataelement-159 |
Id | nfdhtfcov19-dataelement-159 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Non-interventional [RESOURCE] type
### Properties
Design.studyType.nonInterventional | Design.studyType.nonInterventional
Relationship | Specialization nonInterventional ( - 2022‑11‑28)
Rationale | Description: The primary strategy for participant identification and follow-up.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] DDI [ https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html] MIABIS [ https://github.com/BBMRI-ERIC/miabis]
Comment | Cardinality: 1..*, if Design.primaryDesign == 'Non-interventional'; otherwise 0..0
Comment | Cardinality: 1..*, if Design.primaryDesign == 'C142615'; otherwise 0..0
Operationalization | Short input help: Select all that apply. If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Case-control | Group of individuals with specific characteristics (for example, conditions or exposures) compared to group(s) with different characteristics, but otherwise similar. A case-control study design compares two groups of subjects: those with the disease or condition under study (cases) and a very similar group of subjects who do not have the disease or condition (controls) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "C15197" (Case-Control Study) from code system "FDA RouteOfAdministration"
Nested case-control | (1) A study in which a group or cohort of individuals is followed for a certain length of time or until a specific outcome is reached. Studies of this type incorporate the strengths of both cohort and case-control studies but eliminates a portion of the methodologic challenges inherent in both types of studies; (2) For each identified case one or more controls are selected, which are still under observation in a cohort study at the time when the case developed the disease of interest [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C48202" (Nested Case-control Study) from code system "FDA RouteOfAdministration"
Case-only | Single group of individuals with specific characteristics [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "003" (Case-only) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Case-crossover | Characteristics of case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of same case at a prior time (that is, control period) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C127779" (Observational Case-Crossover Study) from code system "FDA RouteOfAdministration"
Ecologic or community studies | Geographically defined populations, such as countries or regions within a country, compared on a variety of environmental (for example, air pollution intensity, hours of sunlight) and/or global measures not reducible to individual level characteristics (for example, healthcare system, laws or policies median income, average fat intake, disease rate) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C127780" (Ecologic or Community Based Study) from code system "FDA RouteOfAdministration"
Family-based | Studies conducted among family members, such as genetic studies within families or twin studies and studies of family environment [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15407" (Family Study) from code system "FDA RouteOfAdministration"
Twin study | Twin studies measure the contribution of genetics (as opposed to environment) to a given trait or condition of interest [MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "D018433" (Twin Studies as Topic) from code system "MeSH"
Cohort | (1) Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period; (2) Data collected over time from the same cohort of respondents. The individuals in the cohort are connected in some way or have shared some significant experience within a given period. In some cases, the samples may differ between waves but are drawn from the same cohort. Examples: birth year, disease (clinical trials), common problem (intervention studies), education, employment, family formation, participation in an event; (3) A form of longitudinal study for the analysis of risk factors following a group of people who do not have a disease, and uses correlations to determine the absolute risk of subject contraction [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "C15208" (Cohort Study) from code system "FDA RouteOfAdministration"
Case-cohort | A random subcohort from the overall cohort is picked and all cases (either within this random subcohort or outside) will be selected as well. Also a suitable design for the investigation of several diseases in parallel. | code "004" (Case-cohort studies) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Birth cohort | A cohort study for which the subjects are followed from the time of birth usually including information about gestation and follow up [MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "D015331" (Birth Cohort Study) from code system "MeSH"
Trend | Data are collected from different samples or different groups of people from the same population at several points in time, using at least partly the same set of questions/variables. Conclusions are drawn for the population. Examples: European Social Survey (ESS), national longitudinal crime surveys [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "005" (Trend) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Panel | Data are collected over time from, or about, the same sample of respondents. Differs from cohort data in that the selection of respondents is not based on their being connected in some way or having shared some significant experience [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "C53311" (Panel Study) from code system "FDA RouteOfAdministration"
Longitudinal | (1) Data collected repeatedly over time to allow studying change in a population. At least some of the questions or modules are repeated over waves. Use the broad term when none of the subterms is suitable; (2) Research studies involving repeated observations of the same entity over time. In the biobank context, longitudinal studies sample a group of people in a given time period, and study them at intervals by the acquisition and analyses of data and/or samples over time [MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "C15273" (Longitudinal Study) from code system "FDA RouteOfAdministration"
Cross-section | (1) Data collected by observing subjects within the study period, without regard to changes over time. May include more than one collection event. Analysis of cross-sectional data often consists in comparing the differences and similarities among subjects; (2) A type of observational study that involves data collection from a population, or a representative subset, at one specific point in time [MIABIS (https://github.com/BBMRI-ERIC/miabis), DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "C53310" (Cross-Sectional Study) from code system "FDA RouteOfAdministration"
Cross-section ad-hoc follow-up | Data are collected at one point in time to complete information collected in a previous cross-sectional study; the decision to collect follow-up data was not included in the original study design [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "006" (Cross-section ad-hoc follow-up) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Time series | Data are collected repeatedly over time to study change in observations. These are typically "objective" measurements of phenomena that can be observed externally, as opposed to attitudes/opinions or feelings. Examples may include economic/financial indicators, natural/meteorological phenomena, vital statistics, etc. [DDI (https://ddialliance.org/Specification/DDI-CV/TimeMethod_1.2.html)]. | code "C181915" (Time Series) from code system "FDA RouteOfAdministration"
Quality control | A quality control testing study design type is where some aspect of the experiment is quality controlled for the purposes of quality assurance [MIABIS (https://github.com/BBMRI-ERIC/miabis)]. | code "007" (Quality control) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Registry | An observational study which includes an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health] | code "C129000" (Patient Registry Study) from code system "FDA RouteOfAdministration"
Other | A study type that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Unknown | The study type is unknown [NFDI4Health]. | code "C17998" (Unknown) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Type_Non_Interventional_NCI_MSH_Local (version 2024‑01‑18 20:52:13)
conditions nfdhtfcov19-dataelement-160 | link
Id | nfdhtfcov19-dataelement-160 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Primary health condition(s) or disease(s) considered in the [RESOURCE]
### Properties
Design.conditions | Design.conditions
Relationship | Specialization studyConditions ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about primary health condition(s) or disease(s) considered in the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 0..*
label nfdhtfcov19-dataelement-161 |
Id | nfdhtfcov19-dataelement-161 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Primary health condition or disease name
### Properties
Design.conditions.label | Design.conditions.label
Relationship | Specialization label ( - 2022‑11‑28)
Rationale | Description: Name of primary health condition or disease considered in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed.
Comment | Cardinality: 1..1
Operationalization | Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
Value Domain | String
Example | SARS-CoV-2
classification nfdhtfcov19-dataelement-162 |
Id | nfdhtfcov19-dataelement-162 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Terminology/classification
### Properties
Design.conditions.classification | Design.conditions.classification
Relationship | Specialization classification ( - 2022‑11‑28)
Rationale | Description: Terminology/classification used for the health condition or disease.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Operationalization | Short input help: If used, name of the terminology/classification.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
MeSH | MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus. To search for terms, the following service can be used: https://meshb.nlm.nih.gov/ [NFDI4Health]. | code "C82845" (Medical Subject Headings) from code system "FDA RouteOfAdministration"
ICD-10 | International Statistical Classification of Diseases and Related Health Problems 10th Revision. To search for terms, the follwoing service can be used: https://icd.who.int/browse10/2016/en [NFDI4Health]. | code "C185253" (ICD-10 Code) from code system "FDA RouteOfAdministration"
MedDRA | MedDRA (Medical Dictionary for Regulatory Activities) is a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. For more details, please visit: https://www.meddra.org/ [NFDI4Health]. | code "C43820" (MedDRA) from code system "FDA RouteOfAdministration"
SNOMED CT | SNOMED CT (SNOMED Clinical Terms) is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. To search for terms, the following service can be used: https://browser.ihtsdotools.org/?perspective=full&conceptId1=408579009&edition=MAIN/2022-08-31&release=&languages=en [NFDI4Health]. | code "C49469" (Systematized Nomenclature of Medicine Clinical Terms) from code system "FDA RouteOfAdministration"
Other vocabulary | A vocabulary that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Free text | A controlled vocabulary was not used for the provided terms [NFDI4Health]. | code "C70764" (Free Text Format) from code system "FDA RouteOfAdministration"
ICD-11 | International Statistical Classification of Diseases and Related Health Problems 11th Revision [NFDI4Health]. | code "196" (ICD-11) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"
Value Set required NFDI4Health_VS_MDS_Study_Conditions_Classification_NCI_Local (version 2023‑12‑13 16:58:18)
Example | SNOMED CT
code nfdhtfcov19-dataelement-163 |
Id | nfdhtfcov19-dataelement-163 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Code of the health condition or disease
### Properties
Design.conditions.code | Design.conditions.code
Relationship | Specialization code ( - 2022‑11‑28)
Rationale | Description: Code of the health condition or disease in the terminology/classification used.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Data type in Excel version: uri
Operationalization | Short input help: If known, you can provide the code from the terminology/classification used.
Value Domain | String
Example | http://snomed.info/id/840533007
focus nfdhtfcov19-dataelement-164 | link
Id | nfdhtfcov19-dataelement-164 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-132 (2023‑12‑04 13:28:30)
Description | Primary focus of the [RESOURCE]
### Properties
Design.focus | Design.focus
Rationale | Description: Group of items providing information about the focus of the [RESOURCE] (e.g. medication, food, therapy, device, etc.).
Source | NFDI4Health
Comment | Cardinality: 0..*
label nfdhtfcov19-dataelement-165 |
Id | nfdhtfcov19-dataelement-165 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-133 (2023‑12‑04 13:30:22)
Description | Focus area
### Properties
Design.focus.label | Design.focus.label
Rationale | Description: Focus area of the [RESOURCE] (e.g. medication, food, therapy, device, etc.).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD, etc.) is preferred. However, also self-assigned terms are allowed.
Comment | Cardinality: 1..1
Operationalization | Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
Value Domain | String
classification nfdhtfcov19-dataelement-166 |
Id | nfdhtfcov19-dataelement-166 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-134 (2023‑12‑04 13:33:11)
Description | Terminology/classification
### Properties
Design.focus.classification | Design.focus.classification
Rationale | Description: Terminology/classification used for the focus area.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Operationalization | Short input help: If used, name of the terminology/classification.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
MeSH | MeSH (Medical Subject Headings) is the NLM controlled vocabulary thesaurus. To search for terms, the following service can be used: https://meshb.nlm.nih.gov/ [NFDI4Health]. | code "C82845" (Medical Subject Headings) from code system "FDA RouteOfAdministration"
ICD-10 | International Statistical Classification of Diseases and Related Health Problems 10th Revision. To search for terms, the follwoing service can be used: https://icd.who.int/browse10/2016/en [NFDI4Health]. | code "C185253" (ICD-10 Code) from code system "FDA RouteOfAdministration"
ICD-11 | International Statistical Classification of Diseases and Related Health Problems 11th Revision [NFDI4Health]. | code "196" (ICD-11) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"
MedDRA | MedDRA (Medical Dictionary for Regulatory Activities) is a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. For more details, please visit: https://www.meddra.org/ [NFDI4Health]. | code "C43820" (MedDRA) from code system "FDA RouteOfAdministration"
SNOMED CT | SNOMED CT (SNOMED Clinical Terms) is a systematically organized computer-processable collection of medical terms providing codes, terms, synonyms and definitions used in clinical documentation and reporting. To search for terms, the following service can be used: https://browser.ihtsdotools.org/?perspective=full&conceptId1=408579009&edition=MAIN/2022-08-31&release=&languages=en [NFDI4Health]. | code "C49469" (Systematized Nomenclature of Medicine Clinical Terms) from code system "FDA RouteOfAdministration"
Other vocabulary | A vocabulary that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Free text | A controlled vocabulary was not used for the provided terms [NFDI4Health]. | code "C70764" (Free Text Format) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Conditions_Classification_NCI_Local (version 2023‑12‑13 16:58:18)
Example | SNOMED CT
code nfdhtfcov19-dataelement-167 |
Id | nfdhtfcov19-dataelement-167 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-135 (2023‑12‑04 13:58:36)
Description | Code of the focus area
### Properties
Design.focus.code | Design.focus.code
Rationale | Description: Code of the focus area in the terminology/classification used.
Source | DataCite [ https://doi.org/10.14454/3w3z-sa82]
Comment | Cardinality: 0..1
Comment | Data type in Excel version: uri
Operationalization | Short input help: If known, you can provide the code from the terminology/classification used.
Value Domain | String
Example | http://snomed.info/id/840533007
groupsOfDiseases nfdhtfcov19-dataelement-168 | link
Id | nfdhtfcov19-dataelement-168 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Groups of diseases or conditions
### Properties
Design.groupsOfDiseases | Design.groupsOfDiseases
Relationship | Specialization studyGroupsOfDiseases ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about groups of diseases or conditions on which the data were collected in the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 1..1
generally nfdhtfcov19-dataelement-169 |
Id | nfdhtfcov19-dataelement-169 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Which groups of diseases or conditions were the data collected on?
### Properties
Design.groupsOfDiseases.generally | Design.groupsOfDiseases.generally
Relationship | Specialization generally ( - 2022‑11‑28)
Rationale | Description: General groups of diseases or conditions on which the data were collected in the [RESOURCE].
Source | ICD-10 [ https://icd.who.int/browse10/2019/en]
Comment | Additional information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10).
Comment | Cardinality: 1..*
Operationalization | Short input help: Select all that apply. For more information about the groups of diseases/conditions, visit the WHO's ICD-10 homepage: https://icd.who.int/en.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Certain infectious or parasitic diseases (I) |  | code "I" (Certain infectious and parasitic diseases) from code system "ICD-10"
Neoplasms (II) |  | code "II" (Neoplasms) from code system "ICD-10"
Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III) |  | code "III" (Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism) from code system "ICD-10"
Endocrine, nutritional and metabolic diseases (IV) |  | code "IV" (Endocrine, nutritional and metabolic diseases) from code system "ICD-10"
Mental and behavioural disorders (V) |  | code "V" (Mental and behavioural disorders) from code system "ICD-10"
Diseases of the nervous system (VI) |  | code "VI" (Diseases of the nervous system) from code system "ICD-10"
Diseases of the eye and adnexa (VII) |  | code "VII" (Diseases of the eye and adnexa) from code system "ICD-10"
Diseases of the ear or mastoid process (VIII) |  | code "VIII" (Diseases of the ear and mastoid process) from code system "ICD-10"
Diseases of the circulatory system (IX) |  | code "IX" (Diseases of the circulatory system) from code system "ICD-10"
Diseases of the respiratory system (X) |  | code "X" (Diseases of the respiratory system) from code system "ICD-10"
Diseases of the digestive system (XI) |  | code "XI" (Diseases of the digestive system) from code system "ICD-10"
Diseases of the skin and subcutaneous tissue (XII) |  | code "XII" (Diseases of the skin and subcutaneous tissue) from code system "ICD-10"
Diseases of the musculoskeletal system and connective tissue (XIII) |  | code "XIII" (Diseases of the musculoskeletal system and connective tissue) from code system "ICD-10"
Diseases of the genitourinary system (XIV) |  | code "XIV" (Diseases of the genitourinary system) from code system "ICD-10"
Pregnancy, childbirth or the puerperium (XV) |  | code "XV" (Pregnancy, childbirth and the puerperium) from code system "ICD-10"
Certain conditions originating in the perinatal period (XVI) |  | code "XVI" (Certain conditions originating in the perinatal period) from code system "ICD-10"
Congenital malformations, deformations and chromosomal abnormalities (XVII) |  | code "XVII" (Congenital malformations, deformations and chromosomal abnormalities) from code system "ICD-10"
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (XVIII) |  | code "XVIII" (Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified) from code system "ICD-10"
Injury, poisoning and certain other consequences of external causes (XIX) |  | code "XIX" (Injury, poisoning and certain other consequences of external causes) from code system "ICD-10"
External causes of morbidity or mortality (XX) |  | code "XX" (External causes of morbidity and mortality) from code system "ICD-10"
Factors influencing health status and contact with health services (XXI) |  | code "XXI" (Factors influencing health status and contact with health services) from code system "ICD-10"
Other |  | code "74964007" (Other) from code system "SNOMED Clinical Terms"
Not applicable |  | code "385432009" (Not applicable) from code system "SNOMED Clinical Terms"
Unknown |  | code "261665006" (Unknown) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_ICD10_SCT (version 2024‑01‑02 13:45:35)
conditions nfdhtfcov19-dataelement-170 |
Id | nfdhtfcov19-dataelement-170 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | On which diseases or conditions were the data collected?
### Properties
Design.groupsOfDiseases.conditions | Design.groupsOfDiseases.conditions
Relationship | Specialization conditions ( - 2022‑11‑28)
Rationale | Description: Diseases or conditions on which the data were collected in the [RESOURCE].
Source | ICD-10 [ https://icd.who.int/browse10/2019/en] NFDI4Health UC 5.2 requirements
Comment | Additional information: The values originate from the WHO's International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10).
Comment | Cardinality: 0..*
Operationalization | Short input help: Select all that apply. Values are based on lower level ICD-10. For more information visit the WHO's ICD-10 homepage: https://icd.who.int/en.
Value Domain | Code
Choice list |
Concept List
Concept | Description
Lower level ICD-10 (https://icd.who.int/browse10/2019/en), with autocomplete |
Value Set required NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_Conditions_ICD10 (version 2024‑03‑01 13:36:49)
mortalityData nfdhtfcov19-dataelement-171 |
Id | nfdhtfcov19-dataelement-171 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Collects mortality data?
### Properties
Design.mortalityData | Design.mortalityData
Relationship | Specialization mortalityData ( - 2022‑11‑28)
Rationale | Description: Indication whether mortality data are collected in the [RESOURCE].
Source | NFDI4Health UC 5.2 requirements
Comment | Cardinality: 0..1, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.studyType.nonInterventional == ('Longitudinal' OR 'Cohort' OR 'Case-cohort' OR 'Birth cohort' OR 'Trend' OR 'Panel')) OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0
Comment | Cardinality: 0..1, if (Resource.classification.type == ('C63536' OR 'C198230') AND Design.studyType.nonInterventional == ('C15273' OR 'C15208' OR '004' OR 'D015331' OR '005' OR 'C53311')) OR Resource.classification.type == ('C61393' OR '178'); otherwise 0..0
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes, vital status only (cause of death missing) |  | code "C25717" (Vital Status) from code system "NCI Metathesaurus"
Yes, with cause of death |  | code "C81239" (Cause of Death) from code system "NCI Metathesaurus"
No |  | code "C49487" (No (Classification)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Mortality_Data_NCI (version 2023‑08‑28 21:27:20)
administrativeInformation nfdhtfcov19-dataelement-172 | link
Id | nfdhtfcov19-dataelement-172 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-136 (2023‑12‑04 15:05:35)
Description | Administrative information about the [RESOURCE]
### Properties
Design.administrativeInformation | Design.administrativeInformation
Rationale | Description: Group of items providing administrative information about the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..1
Comment | Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..1
ethicsCommiteeApproval nfdhtfcov19-dataelement-173 |
Id | nfdhtfcov19-dataelement-173 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Status of the ethics committee approval
### Properties
Design.administrativeInformation.ethicsCommitteeApproval | Design.administrativeInformation.ethicsCommitteeApproval
Relationship | Specialization ethicsCommiteeApproval ( - 2022‑11‑28)
Rationale | Description: Status of the [RESOURCE] approval from the (leading) ethics committee.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Request for approval not yet submitted |  | code "026" (Request for approval not yet submitted) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Request for approval submitted, approval pending |  | code "C53470" (Pending) from code system "FDA RouteOfAdministration"
Request for approval submitted, approval granted |  | code "C25425" (Approval) from code system "FDA RouteOfAdministration"
Request for approval submitted, exempt granted |  | code "C73530" (Exemption) from code system "FDA RouteOfAdministration"
Request for approval submitted, approval denied |  | code "C74933" (Denied) from code system "FDA RouteOfAdministration"
Approval not required |  | code "C48660" (Not Applicable) from code system "FDA RouteOfAdministration"
Study withdrawn prior to decision on approval |  | code "C70758" (Study Withdrawn) from code system "FDA RouteOfAdministration"
Unknown status of request approval |  | code "C17998" (Unknown) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Ethics_Committee_Approval_NCI_Local (version 2024‑01‑04 09:46:52)
status nfdhtfcov19-dataelement-174 |
Id | nfdhtfcov19-dataelement-174 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Overall [RESOURCE] status
### Properties
Design.administrativeInformation.status | Design.administrativeInformation.status
Relationship | Specialization status ( - 2022‑11‑28)
Rationale | Description: Overall status of the [RESOURCE].
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: If at least one [RESOURCE] site in a multicenter [RESOURCE] has the status 'Ongoing', then the overall status of the [RESOURCE] must be 'Ongoing'.
Comment | Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
At the planning stage |  | code "01" (At the planning stage) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (I): Recruitment ongoing, but data collection not yet started |  | code "02" (Ongoing (I) - Recruitment ongoing, but data collection not yet started) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (II): Recruitment and data collection ongoing |  | code "03" (Ongoing (II) - Recruitment and data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (III): Recruitment completed, but data collection ongoing |  | code "04" (Ongoing (III) - Recruitment completed, but data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing |  | code "05" (Ongoing (IV) - Recruitment and data collection completed, but data quality management ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume |  | code "06" (Suspended - Recruitment, data collection, or data quality management, halted, but potentially will resume) from code system "NFDI4Health_CS_MDS_Study_Status"
Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume |  | code "07" (Terminated - Recruitment, data collection, data and quality management halted prematurely and will not resume) from code system "NFDI4Health_CS_MDS_Study_Status"
Completed: Recruitment, data collection, and data quality management completed normally |  | code "08" (Completed - Recruitment, data collection, and data quality management completed normally) from code system "NFDI4Health_CS_MDS_Study_Status"
Other |  | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Overall_Status_NCI_Local (version 2024‑01‑04 10:14:22)
statusWhenIntervention nfdhtfcov19-dataelement-175 |
Id | nfdhtfcov19-dataelement-175 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Participants receive an intervention?
### Properties
Design.administrativeInformation.statusWhenIntervention | Design.administrativeInformation.statusWhenIntervention
Relationship | Specialization statusWhenIntervention ( - 2022‑11‑28)
Rationale | Description: Specification whether [RESOURCE] participants receive an intervention or have completed it but are still being followed up according to the primary objective of the [RESOURCE].
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional' AND Design.administrativeInformation.status == ('At the planning stage' OR 'Ongoing (I): Recruitment ongoing, but data collection not yet started' OR 'Ongoing (II): Recruitment and data collection ongoing' OR 'Ongoing (III): Recruitment completed, but data collection ongoing' OR 'Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign == 'C98388' AND Design.administrativeInformation.status == ('01' OR '02' OR '03' OR '04' OR '05'); otherwise 0..0
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Intervention ongoing |  | code "014" (Intervention ongoing) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Intervention completed, follow-up ongoing |  | code "015" (Intervention completed, follow-up ongoing) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set required NFDI4Health_VS_MDS_Study_Status_When_Intervention_Local (version 2023‑09‑05 19:39:49)
stageStopped nfdhtfcov19-dataelement-176 |
Id | nfdhtfcov19-dataelement-176 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Stopping stage
### Properties
Design.administrativeInformation.stageStopped | Design.administrativeInformation.stageStopped
Relationship | Specialization stageStopped ( - 2022‑11‑28)
Rationale | Description: Specification of the stage at which the [RESOURCE] was prematurely stopped.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.administrativeInformation.status == ('06' OR '07'); otherwise 0..0
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
At the planning stage |  | code "01" (At the planning stage) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (I): Recruitment ongoing, but data collection not yet started |  | code "02" (Ongoing (I) - Recruitment ongoing, but data collection not yet started) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (II): Recruitment and data collection ongoing |  | code "03" (Ongoing (II) - Recruitment and data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (III): Recruitment completed, but data collection ongoing |  | code "04" (Ongoing (III) - Recruitment completed, but data collection ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Ongoing (IV): Recruitment and data collection completed, but data quality management ongoing |  | code "05" (Ongoing (IV) - Recruitment and data collection completed, but data quality management ongoing) from code system "NFDI4Health_CS_MDS_Study_Status"
Value Set NFDI4Health_VS_MDS_Study_Status_Halted_Stage_Local (version 2023‑09‑05 20:02:19)
reasonStopped nfdhtfcov19-dataelement-177 |
Id | nfdhtfcov19-dataelement-177 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Stopping reason
### Properties
Design.administrativeInformation.reasonStopped | Design.administrativeInformation.reasonStopped
Relationship | Specialization reasonStopped ( - 2022‑11‑28)
Rationale | Description: Specification of the reason(s) why the [RESOURCE] was prematurely stopped.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.administrativeInformation.status == ('Suspended: Recruitment, data collection, or data quality management, halted, but potentially will resume' OR 'Terminated: Recruitment, data collection, data and quality management halted prematurely and will not resume'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.administrativeInformation.status == ('06' OR '07'); otherwise 0..0
Operationalization | Short input help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc.
Value Domain | String
Example | accrual goal met
statusEnrollingByInvitation nfdhtfcov19-dataelement-178 |
Id | nfdhtfcov19-dataelement-178 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Participants enrolled by invitation?
### Properties
Design.administrativeInformation.statusEnrollingByInvitation | Design.administrativeInformation.statusEnrollingByInvitation
Relationship | Specialization statusEnrollingByInvitation ( - 2022‑11‑28)
Rationale | Description: Specification whether [RESOURCE] participants are selected from a predetermined population.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Not applicable |  | code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (version 2023‑08‑28 21:57:28)
recruitmentStatusRegister nfdhtfcov19-dataelement-179 |
Id | nfdhtfcov19-dataelement-179 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Overall recruitment status from the register of clinical trials
### Properties
Design.administrativeInformation.recruitmentStatusRegister | Design.administrativeInformation.recruitmentStatusRegister
Relationship | Specialization recruitmentStatusRegister ( - 2022‑11‑28)
Rationale | Description: Overall recruitment status of the [RESOURCE] as indicated in the corresponding register of clinical trials.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: The item applies only to studies automatically uploaded from the registers of clinical trials.
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Resource.provenance.dataSource != 'Manually collected'; otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Resource.provenance.dataSource != '06'; otherwise 0..0
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Not yet recruiting | Participants are not yet being recruited [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "022" (Not yet recruiting) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Recruiting | Participants are currently being recruited, whether or not any participants have yet been enrolled [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C78343" (Recruitment) from code system "FDA RouteOfAdministration"
Enrolling by invitation | Participants are being (or will be) selected from a predetermined population [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "023" (Enrolling by invitation) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Active, not recruiting | Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "024" (Active, not recruiting) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Completed | The study has concluded normally [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C25250" (Complete) from code system "FDA RouteOfAdministration"
Suspended | Study halted prematurely but potentially will resume [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "385655000" (Suspended) from code system "SNOMED Clinical Terms"
Terminated | Study halted prematurely and will not resume [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "360239007" (Termination - action) from code system "SNOMED Clinical Terms"
Withdrawn | Study halted prematurely, prior to enrollment of first participant [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "025" (Withdrawn) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A recruitment status that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Recruitment_Register_NCI_SCT_Local (version 2024‑01‑04 10:26:57)
startDate nfdhtfcov19-dataelement-180 |
Id | nfdhtfcov19-dataelement-180 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Start date
### Properties
Design.administrativeInformation.startDate | Design.administrativeInformation.startDate
Relationship | Specialization studyStartDate ( - 2022‑11‑28)
Rationale | Description: Start date of data collection for the [RESOURCE].
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: Preferred date format: DD.MM.YYYY.
Comment | Cardinality: 0..1
Operationalization | Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date.
Value Domain | Date
endDate nfdhtfcov19-dataelement-181 |
Id | nfdhtfcov19-dataelement-181 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | End date
### Properties
Design.administrativeInformation.endDate | Design.administrativeInformation.endDate
Relationship | Specialization studyEndDate ( - 2022‑11‑28)
Rationale | Description: In case of a [RESOURCE] with patients or other participants, it is the date when the last participant is examined or receives an intervention, or the date of the last participant’s last visit.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: Preferred date format: DD.MM.YYYY.
Comment | Cardinality: 0..1
Operationalization | Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date.
Value Domain | Date
centers nfdhtfcov19-dataelement-182 |
Id | nfdhtfcov19-dataelement-182 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Mono- or multicentric?
### Properties
Design.centers | Design.centers
Relationship | Specialization centers ( - 2022‑11‑28)
Rationale | Description: Specification whether the [RESOURCE] is conducted at only one or at more than one [RESOURCE] center.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Monocentric |  | code "084" (Monocentric) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Multicentric |  | code "255206009" (Multicentric (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Study_Centers_SNOMEDCT_Local (version 2023‑08‑28 23:15:07)
centersNumber nfdhtfcov19-dataelement-183 |
Id | nfdhtfcov19-dataelement-183 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Number of centers
### Properties
Design.centersNumber | Design.centersNumber
Relationship | Specialization centersNumber ( - 2022‑11‑28)
Rationale | Description: Number of centers involved in the [RESOURCE].
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.centers == 'Multicentric'; otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.centers == '255206009'; otherwise 0..0
Comment | Data type in Excel version: integer
Value Domain | Quantity
dataProviders nfdhtfcov19-dataelement-184 |
Id | nfdhtfcov19-dataelement-184 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-137 (2023‑12‑04 19:54:46)
Description | One or more data providers?
### Properties
Design.dataProviders | Design.dataProviders
Rationale | Description: Specification whether the [RESOURCE] involves only one or more than one data provider.
Source | NFDI4Health UC 5.3 requirements
Comment | Cardinality: 0..1, if Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C61393' OR '178'); otherwise 0..0
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
One data provider |  | code "199" (One data provider) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"
Several data providers |  | code "200" (Several data providers) from code system "NFDI4Health_CS_MDS_Remaining_Concepts3.3"
Value Set required NFDI4Health_VS_MDS_Study_Data_Providers_Local (version 2024‑03‑01 10:27:54)
dataProvidersNumber nfdhtfcov19-dataelement-185 |
Id | nfdhtfcov19-dataelement-185 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-138 (2023‑12‑04 19:57:13)
Description | Number of data providers
### Properties
Design.dataProvidersNumber | Design.dataProvidersNumber
Rationale | Description: Number of data providers involved in the [RESOURCE].
Source | NFDI4Health UC 5.3 requirements
Comment | Cardinality: 0..1, if Resource.classification.type == ('Registry' OR 'Secondary data source') AND Design.dataProviders == 'Several data providers'; otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C61393' OR '178') AND Design.dataProviders == '200'; otherwise 0..0
Comment | Data type in Excel version: integer
Value Domain | Quantity
subject nfdhtfcov19-dataelement-186 |
Id | nfdhtfcov19-dataelement-186 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Primary subject
### Properties
Design.subject | Design.subject
Relationship | Specialization subject ( - 2022‑11‑28)
Rationale | Description: The primary subject addressed by the [RESOURCE], i.e. a person, an animal or other subject types.
Source | NFDI4Health DDI [ https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.html]
Comment | Cardinality: 1..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Person | Any individual person, irrespective of demographic characteristics, professional, social or legal status, or affiliation [DDI (https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.html)]. | code "125676002" (Person (person)) from code system "SNOMED Clinical Terms"
Animal | A non-human living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "387961004" (Kingdom Animalia (organism)) from code system "SNOMED Clinical Terms"
Other | A study subject that is not covered by any of the other values in this list [NFDI4Health]. | code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
Unknown | The study subject is unknown [NFDI4Health]. | code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Study_Subject_SNOMEDCT (version 2023‑08‑28 23:18:11)
sampling nfdhtfcov19-dataelement-187 | link
Id | nfdhtfcov19-dataelement-187 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Sampling method
### Properties
Design.sampling | Design.sampling
Relationship | Specialization sampling ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the applied sampling method.
Source | NFDI4Health
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
method nfdhtfcov19-dataelement-188 |
Id | nfdhtfcov19-dataelement-188 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Applied sampling method
### Properties
Design.sampling.method | Design.sampling.method
Relationship | Specialization method ( - 2022‑11‑28)
Rationale | Description: Type of the sampling method applied for the selection of [RESOURCE] participants.
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DDI [ https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html]
Comment | Cardinality: 1..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Probability | All units (individuals, households, organizations, etc.) of a target population have a non-zero probability of being included in the sample and this probability can be accurately determined. Use this broader term if a more specific type of probability sampling is not known or is difficult to identify [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "034" (Probability Sampling Method) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Non-probability | The selection of units (individuals, households, organizations, etc.) from the target population is not based on random selection. It is not possible to determine the probability of each element to be sampled. Use this broader term if the specific type of non-probability is not known, difficult to identify, or if multiple non-probability methods are being employed [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C127781" (Non-Probability Sampling Method) from code system "FDA RouteOfAdministration"
Mixed probability and non-probability | Sample design that combines probability and non-probability sampling within the same sampling process. Different types of sampling may be used at different stages of creating the sample. For example, for a sample of minority students in a city, schools are randomly selected in the first stage. Then, a quota sample of students is selected within each school in the second stage. If separate samples are drawn from the same target population using different sampling methods, the type of sampling procedure used for each sample should be classified separately [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "035" (Mixed Probability and Non-Probability Sampling Method) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Total universe/Complete enumeration | All units (individuals, households, organizations, etc.) of a target population are included in the data collection. For example, if the target population is defined as the members of a trade union, all union members are invited to participate in the study. Also called "census" if the entire population of a regional unit (e.g. a country) is selected [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "036" (Total universe/Complete enumeration) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A sampling procedure that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Unknown | The sampling procedure is unknown [NFDI4Health]. | code "C17998" (Unknown) from code system "FDA RouteOfAdministration"
Not applicable | The sampling procedure is not applicable [NFDI4Health]. | code "C48660" (Not Applicable) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Sampling_Method_NCI_Local (version 2024‑01‑18 21:32:05)
probabilityMethod nfdhtfcov19-dataelement-189 |
Id | nfdhtfcov19-dataelement-189 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Specific type of probability sampling
### Properties
Design.sampling.probabilityMethod | Design.sampling.probabilityMethod
Relationship | Specialization probabilityMethod ( - 2022‑11‑28)
Rationale | Description: Specific type of the probability sampling method applied for the selection of [RESOURCE] participants.
Source | NFDI4Health DDI [ https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html]
Comment | Cardinality: 0..1, if Design.sampling.method == 'Probability'; otherwise 0..0
Comment | Cardinality: 0..1, if Design.sampling.method == '034'; otherwise 0..0
Operationalization | Short input help: If known, select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Simple random | A probability-based method. All units of a target population have an equal probability of being included in the sample. Typically, the entire population is listed in a "sample frame", and units are then chosen from this frame using a random selection method [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C53196" (Simple Random Sampling) from code system "FDA RouteOfAdministration"
Systematic random | A probability-based method. A fixed selection interval is determined by dividing the population size by the desired sample size. A starting point is then randomly drawn from the sample frame, which normally covers the entire target population. From this starting point, units for the sample are chosen based on the selection interval. Also known as interval sampling. For example, a company survey seeks a sample of 1,000 employees out of 10,000 total. Beginning with a random starting number, every 10th name from the employee list of the company will be invited to participate in the study [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C53200" (Systematic Sampling) from code system "FDA RouteOfAdministration"
Stratified | A probability-based method. The target population is subdivided into separate and mutually exclusive segments (strata) that cover the entire population. Independent random samples are then drawn from each segment. For example, in a national public opinion survey the entire population is divided into two regional strata: East and West. After this, sampling units are drawn from within each region using simple or systematic random sampling. Use this broader term if the specific type of stratified sampling is not known or difficult to identify [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C71516" (Stratified Sampling) from code system "FDA RouteOfAdministration"
Stratified: Proportional | A probability-based method. The target population is subdivided into separate and mutually exclusive segments (strata) that cover the entire population. In proportional stratified sampling the number of elements chosen from each stratum is proportional to the population size of the stratum when viewed against the entire population. For example, a country is divided into two regional strata that comprise 80 percent (West) and 20 percent (East) of the total population. For a sample of 1,000 people, 800 (i.e., 80 percent) would be drawn from the West and 200 (i.e., 20 percent) from the East to accurately represent their proportion in the total population [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C71498" (Proportional Stratified Sampling) from code system "FDA RouteOfAdministration"
Stratified: Disproportional | A probability-based method. The target population is subdivided into separate and mutually exclusive segments (strata) that cover the entire population. In disproportional sampling the number of units chosen from each stratum is not proportional to the population size of the stratum when viewed against the entire population. The number of sampled units from each stratum can be equal, optimal, or can reflect the purpose of the study, like oversampling of different subgroups of the population. For example, a country is divided into two regional strata that comprise 80 percent (West) and 20 precent (East) of the country's population. If equal representation of the two regions is needed in a study, half the sample may be drawn from the West and half from the East, so that each region is represented by 50 percent of the sample. If a more detailed analysis of the population from the East is needed, 40 percent of the units may be drawn from the West and 60 percent from the East, so that the East is over-represented [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C71497" (Disproportional Stratified Sampling) from code system "FDA RouteOfAdministration"
Cluster | A probability-based method. The target population is divided into naturally occurring segments (clusters) and a probability sample of the clusters is selected. Data are then collected from all units within each selected cluster. Sampling is often clustered by geography, or time period. Use this broader term if a more specific type of cluster sampling is not known or is difficult to identify [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "126" (Cluster) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cluster: Simple random | A probability-based method. The target population is divided into naturally occurring segments (clusters) and a simple random sample of the clusters is selected. Data are then collected from all units within each selected cluster. For example, for a sample of students in a city, a number of schools would be chosen using the random selection method, and then all of the students from every sampled school would be included [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "127" (Cluster - Simple random) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cluster: Stratified random | A probability-based method. The target population is divided into naturally occurring segments (clusters); next, these are divided into mutually exclusive strata and a random sample of clusters is selected from each stratum. Data are then collected from all units within each selected cluster. For example, for a sample of students in a city, schools would be divided into two strata by school type (private vs. public); schools would be then randomly selected from each stratum, and all of the students from every sampled school would be included [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "128" (Cluster - Stratified random) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Multistage | A probability-based method. Sampling is carried out in stages using smaller and smaller units at each stage, and all stages involve a probability selection. The type of probability sampling procedure may be different at each stage. For example, for a sample of students in a city, schools are randomly selected in the first stage. A random sample of classes within each selected school is drawn in the second stage. Students are then randomly selected from each of these classes in the third stage [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C71515" (Multi-Stage Sampling) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Sampling_Probability_Method_NCI_local (version 2024‑01‑18 21:46:02)
nonProbabilityMethod nfdhtfcov19-dataelement-190 |
Id | nfdhtfcov19-dataelement-190 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Specific type of non-probability sampling
### Properties
Design.sampling.nonProbabilityMethod | Design.sampling.nonProbabilityMethod
Relationship | Specialization nonProbabilityMethod ( - 2022‑11‑28)
Rationale | Description: Specific type of the non-probability sampling method applied for the selection of [RESOURCE] participants.
Source | NFDI4Health DDI [ https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html]
Comment | Cardinality: 0..1, if Design.sampling.method == 'Non-probability'; otherwise 0..0
Comment | Cardinality: 0..1, if Design.sampling.method == 'C127781'; otherwise 0..0
Operationalization | Short input help: If known, select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Quota | A non-probability-based method. The target population is subdivided into separate and mutually exclusive segments according to some predefined quotation criteria. The distribution of the quotation criteria (gender/age/ethnicity ratio, or other characteristics, like religion, education, etc.) is intended to reflect the real structure of the target population or the structure of the desired study population. Non-probability samples are then drawn from each segment until a specific number of units has been reached. For example, if the target population consists of 45 percent females and 55 percent males, a proportional quota sample will have the same gender percentages, while in a non-proportional quota sample the percentages will be different, based on some study-related consideration (for instance, the need to oversample for certain under-represented segments of the population) [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C71504" (Quota Sampling) from code system "FDA RouteOfAdministration"
Respondent-assisted | A non-probability-based method. Sample units are identified from a target population with the assistance of units already selected (adapted from "Public Health Research Methods", ed. Greg Guest, Emily E. Namey, 2014). A typical case is snowball sampling, in which the researcher identifies a group of units that matches a particular criterion of eligibility. The latter are asked to recruit other members of the same population that fulfil the same criterion of eligibility (sampling of specific populations like migrants, etc.) [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "008" (Respondent-driven sampling) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Purposive | A non-probability-based method. Sample units are specifically identified, selected and contacted for the information they can provide on the researched topic. Selection is based on different characteristics of the independent and/or dependent variables under study, and relies on the researchers' judgement. The study authors, or persons authorized by them have control over the sample selection mechanism and the universe is defined in terms of the selection criteria. Also called "judgement" sampling. For example, a medical researcher may intentionally select individuals who are similar in most respects, except on the outcome of the research topic, which can be a specific disease. Some types of purposive sampling are typical/deviant case, homogeneous/maximum variation, expert, or critical case sampling [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C71505" (Matched Sampling) from code system "FDA RouteOfAdministration"
Availability | A non-probability-based method. The sample selection is based on the units' accessibility/relative ease of access. They may be easy to approach, or may themselves choose to participate in the study (self-selection). Researchers may have particular target groups in mind but they do not control the sample selection mechanism. For example, students leaving a particular building on campus may be approached, or individuals may volunteer to participate in response to invitations that do not target them specifically, but a larger group to which they may belong. Also called "convenience" or "opportunity" sampling [DDI (https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html)]. | code "C53204" (Convenience Sampling) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Sampling_Method_Non_Probability_NCI_Local (version 2024‑01‑18 22:02:56)
dataSource nfdhtfcov19-dataelement-191 | link
Id | nfdhtfcov19-dataelement-191 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Data sources of the [RESOURCE]
### Properties
Design.dataSource | Design.dataSource
Relationship | Specialization dataSource ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about data sources from which the data of the [RESOURCE] are generated or extracted.
Source | NFDI4Health
Comment | Cardinality: 0..1
general nfdhtfcov19-dataelement-192 |
Id | nfdhtfcov19-dataelement-192 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Type(s) of data sources
### Properties
Design.dataSource.general | Design.dataSource.general
Relationship | Specialization general ( - 2022‑11‑28)
Rationale | Description: Different types of data sources from which the data of the [RESOURCE] are generated or extracted.
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..*
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Biological samples |  | code "C70699" (Biospecimen) from code system "FDA RouteOfAdministration"
Administrative databases |  | code "028" (Administrative databases) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Cognitive measurements |  | code "029" (Cognitive measurements) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Genealogical records |  | code "030" (Genealogical records) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Imaging data |  | code "031" (Imaging data) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Medical records |  | code "C0025102" (Medical Record) from code system "FDA RouteOfAdministration"
Registries |  | code "C61393" (Registry) from code system "FDA RouteOfAdministration"
Interview |  | code "C16751" (Interview) from code system "FDA RouteOfAdministration"
Questionnaire |  | code "C17048" (Questionnaire) from code system "FDA RouteOfAdministration"
Physiological/Biochemical measurements |  | code "032" (Physiological/Biochemical measurements) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Omics technology |  | code "033" (Omics technology) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other |  | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sources_General_NCI_Local (version 2024‑01‑04 13:43:34)
biosamples nfdhtfcov19-dataelement-193 |
Id | nfdhtfcov19-dataelement-193 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Biosamples collected
### Properties
Design.dataSource.biosamples | Design.dataSource.biosamples
Relationship | Specialization biosamples ( - 2022‑11‑28)
Rationale | Description: Specification of biosamples collected in the [RESOURCE].
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..*, if Design.dataSource.general == 'Biological samples'; otherwise 0..0
Comment | Cardinality: 0..*, if Design.dataSource.general == 'C70699'; otherwise 0..0
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Blood |  | code "87612001" (Blood (substance)) from code system "SNOMED Clinical Terms"
Buccal cells |  | code "C172264" (Buccal Cell Sample (Cell)) from code system "NCI Metathesaurus"
Cord blood |  | code "12499000" (Cord blood (substance)) from code system "SNOMED Clinical Terms"
DNA |  | code "24851008" (Deoxyribonucleic acid (substance)) from code system "SNOMED Clinical Terms"
Faeces |  | code "39477002" (Feces (substance)) from code system "SNOMED Clinical Terms"
Hair |  | code "395508003" (Hair - material (substance)) from code system "SNOMED Clinical Terms"
Immortalized cell lines |  | code "C16403" (Cell Line) from code system "FDA RouteOfAdministration"
Isolated pathogen |  | code "C80324" (Pathogen (Conceptual Entity)) from code system "NCI Metathesaurus"
Nail |  | code "119327009" (Nail specimen (specimen)) from code system "SNOMED Clinical Terms"
Plasma |  | code "50863008" (Plasma (substance)) from code system "SNOMED Clinical Terms"
RNA |  | code "27888000" (Ribonucleic acid (substance)) from code system "SNOMED Clinical Terms"
Saliva |  | code "256897009" (Saliva (substance)) from code system "SNOMED Clinical Terms"
Serum |  | code "67922002" (Serum (substance)) from code system "SNOMED Clinical Terms"
Tissue (frozen) |  | code "16214131000119104" (Frozen tissue section specimen (specimen)) from code system "SNOMED Clinical Terms"
Tissue (FFPE) |  | code "441652008" (Formalin-fixed paraffin-embedded tissue specimen (specimen)) from code system "SNOMED Clinical Terms"
Urine |  | code "78014005" (Urine (substance)) from code system "SNOMED Clinical Terms"
Other biological samples |  | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Study_DS_Biosamples_SCT_NCI (version 2024‑01‑04 18:58:40)
imaging nfdhtfcov19-dataelement-194 |
Id | nfdhtfcov19-dataelement-194 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Imaging data collected
### Properties
Design.dataSource.imaging | Design.dataSource.imaging
Relationship | Specialization imaging ( - 2022‑11‑28)
Rationale | Description: Specification of imaging data collected in the [RESOURCE].
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..*, if Design.dataSource.general == 'Imaging data'; otherwise 0..0
Comment | Cardinality: 0..*, if Design.dataSource.general == '031'; otherwise 0..0
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Ultrasound |  | code "C115503" (Ultrasound Study File (Manufactured Object)) from code system "NCI Metathesaurus"
Magnetic resonance imaging (MRI) |  | code "C115501" (Magnetic Resonance Imaging Study File (Manufactured Object)) from code system "NCI Metathesaurus"
Radiography (x-ray) |  | code "C115721" (Radiography Study File (Intellectual Product)) from code system "NCI Metathesaurus"
Computed tomography (CT) |  | code "C115499" (Computed Tomography Study File (Manufactured Object)) from code system "NCI Metathesaurus"
Other imaging data |  | code "C115545" (Medical Imaging File Not Otherwise Specified (Intellectual Product)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sources_Imaging_NCI (version 2024‑01‑04 19:15:51)
omics nfdhtfcov19-dataelement-195 |
Id | nfdhtfcov19-dataelement-195 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Omics technology used
### Properties
Design.dataSource.omics | Design.dataSource.omics
Relationship | Specialization omics ( - 2022‑11‑28)
Rationale | Description: Specification of omics technology applied in the [RESOURCE].
Source | NFDI4Health MIABIS [ https://github.com/BBMRI-ERIC/miabis] Maelstrom [doi: 10.1371/journal.pone.0200]
Comment | Cardinality: 0..*, if Design.dataSource.general == 'Omics technology'; otherwise 0..0
Comment | Cardinality: 0..*, if Design.dataSource.general == '033'; otherwise 0..0
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Biomarkers |  | code "C63333" (Biomarker Analysis) from code system "NCI Metathesaurus"
Genomics |  | code "C84343" (Genomics) from code system "NCI Metathesaurus"
Metabolomics |  | code "C49019" (Metabolomics) from code system "NCI Metathesaurus"
Transcriptomics |  | code "C153189" (Transcriptomics) from code system "NCI Metathesaurus"
Proteomics |  | code "C20085" (Proteomics) from code system "NCI Metathesaurus"
Other omics technology |  | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sources_Omics_NCI (version 2024‑01‑03 14:30:29)
description nfdhtfcov19-dataelement-196 |
Id | nfdhtfcov19-dataelement-196 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional information about data sources
### Properties
Design.dataSource.description | Design.dataSource.description
Relationship | Specialization description ( - 2022‑11‑28)
Rationale | Description: If needed, additional descriptive information about the data sources of the [RESOURCE], e.g. indication of the data source(s) not listed in the field 'Type(s) of data sources' or a more detailed description of the selected data sources.
Source | NFDI4Health
Comment | Cardinality: 0..1
Operationalization | Short input help: You can indicate here other data source(s) not listed in the field 'Type(s) of data sources' or provide a more detailed description of the selected data sources.
Value Domain | String
primaryPurpose nfdhtfcov19-dataelement-197 |
Id | nfdhtfcov19-dataelement-197 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Primary purpose of the [RESOURCE]
### Properties
Design.primaryPurpose | Design.primaryPurpose
Relationship | Specialization primaryPurpose ( - 2022‑11‑28)
Rationale | Description: Specification of the main purpose of the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: The field is defined foremost for interventional studies. For non-interventional studies, this field may not be applicable as diverse purposes may be pursued without being able to specify a primary one. In this case, the option 'Not applicable' can be selected.
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Operationalization | Short input help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Treatment | One or more interventions are being evaluated for treating a disease, syndrome, or condition [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "treatment" (Treatment) from code system "ResearchStudyPrimaryPurposeType"
Prevention | One or more interventions are being assessed for preventing the development of a specific disease or health condition [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "prevention" (Prevention) from code system "ResearchStudyPrimaryPurposeType"
Prognostic | One or more interventions are being evaluated for making a prediction of the course of the disease [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt), NFDI4Health]. | code "C25263" (Prognostic) from code system "FDA RouteOfAdministration"
Diagnostic | One or more interventions are being evaluated for identifying a disease or health condition [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "diagnostic" (Diagnostic) from code system "ResearchStudyPrimaryPurposeType"
Supportive care | One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "supportive-care" (Supportive Care) from code system "ResearchStudyPrimaryPurposeType"
Screening | One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "screening" (Screening) from code system "ResearchStudyPrimaryPurposeType"
Health services research | One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "health-services-research" (Health Services Research) from code system "ResearchStudyPrimaryPurposeType"
Basic science/Physiological study | One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "basic-science" (Basic Science) from code system "ResearchStudyPrimaryPurposeType"
Device feasibility | An intervention of a device product is being evaluated in a small clinical trial (generally fewer than 10 participants) to determine the feasibility of the product; or a clinical trial to test a prototype device for feasibility and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "device-feasibility" (Device Feasibility) from code system "ResearchStudyPrimaryPurposeType"
Pharmacogenetics | The investigation of the influence of variations in DNA sequence on drug response [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C129001" (Pharmacogenetic Study) from code system "FDA RouteOfAdministration"
Pharmacogenomics | The influence of genotype on drug response, for example by correlating gene expression or single-nucleotide polymorphisms with drug efficacy or toxicity [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49661" (Pharmacogenomic Study) from code system "FDA RouteOfAdministration"
Health economics | Economic aspects of the field of medicine, the medical profession, and health care. It includes the economic and financial impact of disease in general on the patient, the physician, society, or government [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C16527" (Medical Economics) from code system "FDA RouteOfAdministration"
Not applicable | A primary study purpose can not be applied [NFDI4Health]. | code "C48660" (Not Applicable) from code system "FDA RouteOfAdministration"
Other | A purpose that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Primary_Purpose_HL7_NCI (version 2024‑01‑04 10:33:27)
eligibilityCriteria nfdhtfcov19-dataelement-198 | link
Id | nfdhtfcov19-dataelement-198 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Eligibility criteria for [RESOURCE] participants
### Properties
Design.eligibilityCriteria | Design.eligibilityCriteria
Relationship | Specialization eligibilityCriteria ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about eligibility criteria for [RESOURCE] participants.
Source | NFDI4Health
Comment | Cardinality: 0..1
ageMin nfdhtfcov19-dataelement-199 | link
Id | nfdhtfcov19-dataelement-199 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Eligibility criteria: Minimum age
### Properties
Design.eligibilityCriteria.ageMin | Design.eligibilityCriteria.ageMin
Relationship | Specialization ageMin ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the minimum eligible age of [RESOURCE] participants.
Source | NFDI4Health
Comment | Cardinality: 0..1
number nfdhtfcov19-dataelement-200 |
Id | nfdhtfcov19-dataelement-200 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Minimum eligible age
### Properties
Design.eligibilityCriteria.ageMin.number | Design.eligibilityCriteria.ageMin.number
Relationship | Specialization number ( - 2022‑11‑28)
Rationale | Description: Numerical value of the minimum age of potential participants eligible to participate in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'.
Comment | Cardinality: 1..1
Comment | Data type in Excel version: integer
Operationalization | Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.
Value Domain | Quantity
timeUnit nfdhtfcov19-dataelement-201 |
Id | nfdhtfcov19-dataelement-201 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Unit of age
### Properties
Design.eligibilityCriteria.ageMin.timeUnit | Design.eligibilityCriteria.ageMin.timeUnit
Relationship | Specialization timeUnit ( - 2022‑11‑28)
Rationale | Description: Unit of measurement used to describe the minimum eligible age.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Hours |  | code "h" (hour) from code system "UCUM"
Minutes |  | code "min" (minute) from code system "UCUM"
Weeks of gestation |  | code "49051-6" (Gestational age in weeks) from code system "LOINC"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (version 2024‑01‑05 14:59:31)
ageMax nfdhtfcov19-dataelement-202 | link
Id | nfdhtfcov19-dataelement-202 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Eligibility criteria: Maximum age
### Properties
Design.eligibilityCriteria.ageMax | Design.eligibilityCriteria.ageMax
Relationship | Specialization ageMax ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the maximum eligible age of [RESOURCE] participants.
Source | NFDI4Health
Comment | Cardinality: 0..1
number nfdhtfcov19-dataelement-203 |
Id | nfdhtfcov19-dataelement-203 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Maximum eligible age
### Properties
Design.eligibilityCriteria.ageMax.number | Design.eligibilityCriteria.ageMax.number
Relationship | Specialization number ( - 2022‑11‑28)
Rationale | Description: Numerical value of the maximum age of potential participants eligible to participate in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'.
Comment | Cardinality: 1..1
Comment | Data type in Excel version: integer
Operationalization | Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.
Value Domain | Quantity
timeUnit nfdhtfcov19-dataelement-204 |
Id | nfdhtfcov19-dataelement-204 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Unit of age
### Properties
Design.eligibilityCriteria.ageMax.timeUnit | Design.eligibilityCriteria.ageMax.timeUnit
Relationship | Specialization timeUnit ( - 2022‑11‑28)
Rationale | Description: Unit of measurement used to describe the maximum eligible age.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Hours |  | code "h" (hour) from code system "UCUM"
Minutes |  | code "min" (minute) from code system "UCUM"
Weeks of gestation |  | code "49051-6" (Gestational age in weeks) from code system "LOINC"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (version 2024‑01‑05 14:59:31)
genders nfdhtfcov19-dataelement-205 |
Id | nfdhtfcov19-dataelement-205 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Eligible gender
### Properties
Design.eligibilityCriteria.genders | Design.eligibilityCriteria.genders
Relationship | Specialization genders ( - 2022‑11‑28)
Rationale | Description: Gender of potential participants eligible to participate in the [RESOURCE].
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..*
Operationalization | Short input help: Select all that apply. If no gender was explicitly excluded in the [RESOURCE], 'Male', 'Female', and 'Diverse' should be selected.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Male |  | code "248153007" (Male) from code system "http://hl7.org/fhir/administrative-gender"
Female |  | code "248152002" (Female) from code system "http://hl7.org/fhir/administrative-gender"
Diverse |  | code "105" (Diverse) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Not applicable |  | code "385432009" (Not applicable) from code system "http://hl7.org/fhir/administrative-gender"
Value Set NFDI4Health_VS_MDS_Study_Eligibility_Gender_SNOMEDCT_Local (version 2023‑08‑29 14:35:27)
inclusionCriteria nfdhtfcov19-dataelement-206 |
Id | nfdhtfcov19-dataelement-206 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Inclusion criteria
### Properties
Design.eligibilityCriteria.inclusionCriteria | Design.eligibilityCriteria.inclusionCriteria
Relationship | Specialization inclusionCriteria ( - 2022‑11‑28)
Rationale | Description: Inclusion criteria for participation in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Operationalization | Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.
Value Domain | String
Example | - First inclusion criterion; - Second inclusion criterion;
exclusionCriteria nfdhtfcov19-dataelement-207 |
Id | nfdhtfcov19-dataelement-207 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Exclusion criteria
### Properties
Design.eligibilityCriteria.exclusionCriteria | Design.eligibilityCriteria.exclusionCriteria
Relationship | Specialization exclusionCriteria ( - 2022‑11‑28)
Rationale | Description: Exclusion criteria for participation in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Operationalization | Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.
Value Domain | String
Example | - First inclusion criterion; - Second inclusion criterion;
population nfdhtfcov19-dataelement-208 | link
Id | nfdhtfcov19-dataelement-208 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-139 (2023‑12‑05 15:32:13)
Description | Population of the [RESOURCE]
### Properties
Design.population | Design.population
Rationale | Description: Group of items providing information about the population of the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 1..1
coverage nfdhtfcov19-dataelement-209 |
Id | nfdhtfcov19-dataelement-209 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-140 (2023‑12‑05 15:34:17)
Description | Coverage
### Properties
Design.population.coverage | Design.population.coverage
Rationale | Description: Specification of the recruitment area of the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 0..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
International |  | code "C25541)" (International) from code system "FDA RouteOfAdministration"
National |  | code "C61423" (National) from code system "FDA RouteOfAdministration"
Regional |  | code "C25643" (Regional) from code system "FDA RouteOfAdministration"
Value Set NFDI4Health_VS_MDS_Population_Coverage_NCI (version 2024‑03‑01 14:58:48)
countries nfdhtfcov19-dataelement-210 |
Id | nfdhtfcov19-dataelement-210 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Country(ies)
### Properties
Design.population.countries | Design.population.countries
Relationship | Specialization countries ( - 2022‑11‑28)
Rationale | Description: Country or countries where the [RESOURCE] takes place.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..*
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description
Country names from the ISO 3166-1 list |
Value Set required http://hl7.org/fhir/ValueSet/country (version 2023‑08‑28 23:09:48)
region nfdhtfcov19-dataelement-211 |
Id | nfdhtfcov19-dataelement-211 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Region(s) and/or city(ies)
### Properties
Design.population.region | Design.population.region
Relationship | Specialization region ( - 2022‑11‑28)
Rationale | Description: If applicable, region(s) and/or city(ies) within a country where the [RESOURCE] takes place.
Source | NFDI4Health
Comment | Cardinality: 0..1
Value Domain | String
description nfdhtfcov19-dataelement-212 |
Id | nfdhtfcov19-dataelement-212 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Population description
### Properties
Design.population.description | Design.population.description
Relationship | Specialization population ( - 2022‑11‑28)
Rationale | Description: Additional descriptive information providing more details about the population of the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Maelstrom [doi: 10.1371/journal.pone.0200926]
Comment | Cardinality: 0..1
Operationalization | Short input help: Any information important for the given [RESOURCE] population can be specified here.
Value Domain | String
targetSampleSize nfdhtfcov19-dataelement-213 |
Id | nfdhtfcov19-dataelement-213 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Target sample size
### Properties
Design.population.targetSampleSize | Design.population.targetSampleSize
Relationship | Specialization targetSampleSize ( - 2022‑11‑28)
Rationale | Description: Intended number of observational units for the whole [RESOURCE] (e.g. intended number of [RESOURCE] participants at all sites of the [RESOURCE]).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Comment | Data type in Excel version: integer
Value Domain | Quantity
obtainedSampleSize nfdhtfcov19-dataelement-214 |
Id | nfdhtfcov19-dataelement-214 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Obtained sample size
### Properties
Design.population.obtainedSampleSize | Design.population.obtainedSampleSize
Relationship | Specialization obtainedSampleSize ( - 2022‑11‑28)
Rationale | Description: Obtained number of observational units for the whole [RESOURCE] (e.g. obtained number of [RESOURCE] participants at all sites of the [RESOURCE]).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: The value is only available after the end of recruitment.
Comment | Cardinality: 0..1
Comment | Data type in Excel version: integer
Value Domain | Quantity
hypothesis nfdhtfcov19-dataelement-215 |
Id | nfdhtfcov19-dataelement-215 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Research questions/hypotheses
### Properties
Design.hypotheses | Design.hypotheses
Relationship | Specialization hypothesis ( - 2022‑11‑28)
Rationale | Description: Statement of the research questions and/or hypotheses underlying the [RESOURCE].
Source | NFDI4Health ISRCTN [ https://www.isrctn.com/]
Comment | Cardinality: 0..*, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..*, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Value Domain | String
arms nfdhtfcov19-dataelement-216 | link
Id | nfdhtfcov19-dataelement-216 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Arms of the [RESOURCE]
### Properties
Design.arms | Design.arms
Relationship | Specialization armsGroups ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the arms of the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 0..*, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional'; otherwise 0..0
Comment | Cardinality: 0..*, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign == 'C98388'; otherwise 0..0
label nfdhtfcov19-dataelement-217 |
Id | nfdhtfcov19-dataelement-217 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Name of the arm
### Properties
Design.arms.label | Design.arms.label
Relationship | Specialization label ( - 2022‑11‑28)
Rationale | Description: Short name used to identify the arm.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Additional information: 'Arm' means a pre-specified group or subgroup of participants in the [RESOURCE] assigned to receive specific intervention(s) (or no intervention) according to a protocol.
Comment | Cardinality: 1..1
Value Domain | String
type nfdhtfcov19-dataelement-218 |
Id | nfdhtfcov19-dataelement-218 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Role of the arm
### Properties
Design.arms.type | Design.arms.type
Relationship | Specialization type ( - 2022‑11‑28)
Rationale | Description: Role of the given arm in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Experimental | An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C174266" (Investigational Arm) from code system "FDA RouteOfAdministration"
Active comparator | An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C174267" (Active Comparator Arm) from code system "FDA RouteOfAdministration"
Placebo comparator | An arm type in which a group of participants receives a placebo during a clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C174268" (Placebo Control Arm) from code system "FDA RouteOfAdministration"
Sham comparator | An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C174269" (Sham Comparator Arm) from code system "FDA RouteOfAdministration"
No intervention | An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C174270" (No Intervention Arm) from code system "FDA RouteOfAdministration"
Other | A type of the study arm that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Arm_Group_Type_NCI (version 2024‑01‑03 15:32:24)
description nfdhtfcov19-dataelement-219 |
Id | nfdhtfcov19-dataelement-219 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional information about the arm
### Properties
Design.arms.description | Design.arms.description
Relationship | Specialization description ( - 2022‑11‑28)
Rationale | Description: Additional descriptive information about the given arm.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: If needed, additional descriptive information (including which interventions are administered in each arm) to differentiate each arm from other arms in the [RESOURCE].
Comment | Cardinality: 0..1
Value Domain | String
groups nfdhtfcov19-dataelement-220 | link
Id | nfdhtfcov19-dataelement-220 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-141 (2023‑12‑05 16:12:06)
Description | Groups/cohorts of the [RESOURCE]
### Properties
Design.groups | Design.groups
Rationale | Description: Group of items providing information about the groups/cohorts of the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 0..*, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Non-interventional'; otherwise 0..0
Comment | Cardinality: 0..*, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign == 'C142615'; otherwise 0..0
label nfdhtfcov19-dataelement-221 |
Id | nfdhtfcov19-dataelement-221 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-142 (2023‑12‑05 16:13:54)
Description | Name of the group
### Properties
Design.groups.label | Design.groups.label
Rationale | Description: Short name used to identify the group.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Additional information: 'Group' means a predefined group (cohort) of participants to be studied.
Comment | Cardinality: 1..1
Value Domain | String
description nfdhtfcov19-dataelement-222 |
Id | nfdhtfcov19-dataelement-222 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-143 (2023‑12‑05 16:15:58)
Description | Additional information about the group
### Properties
Design.groups.description | Design.groups.description
Rationale | Description: Additional descriptive information about the given group.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Additional information: Explanation of the nature of the [RESOURCE] group (for example, participants with and without a condition, participants with and without an exposure, etc.).
Comment | Cardinality: 0..1
Value Domain | String
interventions nfdhtfcov19-dataelement-223 | link
Id | nfdhtfcov19-dataelement-223 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Interventions of the [RESOURCE]
### Properties
Design.interventions | Design.interventions
Relationship | Specialization interventions ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the interventions of the [RESOURCE].
Source | NFDI4Health
Comment | Additional information: Specification of the intervention(s) associated with each arm.
Comment | Cardinality: 0..*, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Interventional'; otherwise 0..0
Comment | Cardinality: 0..*, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign == 'C98388'; otherwise 0..0
name nfdhtfcov19-dataelement-224 |
Id | nfdhtfcov19-dataelement-224 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Name of the intervention
### Properties
Design.interventions.name | Design.interventions.name
Relationship | Specialization name ( - 2022‑11‑28)
Rationale | Description: A short descriptive name of the intervention.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1
Operationalization | Short input help: If the same intervention is associated with more than one arm, please provide the information once and use the field 'Name(s) of the arm(s) associated with the given intervention' to associate it with more than one arm.
Value Domain | String
type nfdhtfcov19-dataelement-225 |
Id | nfdhtfcov19-dataelement-225 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Type of the intervention
### Properties
Design.interventions.type | Design.interventions.type
Relationship | Specialization type ( - 2022‑11‑28)
Rationale | Description: General type of the given intervention.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Drug (including placebo) |  | code "C1909" (Pharmacologic Substance (Pharmacologic Substance)) from code system "NCI Metathesaurus"
Device (including sham) |  | code "C62103" (Device (Manufactured Object)) from code system "NCI Metathesaurus"
Biological/Vaccine |  | code "C923" (Vaccine) from code system "FDA RouteOfAdministration"
Procedure/Surgery |  | code "C79751" (Procedure (Activity)) from code system "NCI Metathesaurus"
Radiation |  | code "C15313" (Radiation Therapy) from code system "FDA RouteOfAdministration"
Behavioral (e.g., psychotherapy, lifestyle counseling) |  | code "C15184" (Behavioral Intervention (Therapeutic or Preventive Procedure)) from code system "NCI Metathesaurus"
Genetic (including gene transfer, stem cell and recombinant DNA) |  | code "C17938" (Genetic (Functional Concept)) from code system "NCI Metathesaurus"
Dietary supplement (e.g., vitamins, minerals) |  | code "C1505" (Dietary Supplement (Food)) from code system "NCI Metathesaurus"
Combination product (combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device) |  | code "C54696" (Combination Product (Manufactured Object)) from code system "NCI Metathesaurus"
Diagnostic test (e.g., imaging, in-vitro) |  | code "C17454" (Diagnostic Test (Diagnostic Procedure)) from code system "NCI Metathesaurus"
Other |  | code "C17649" (Other (Qualitative Concept)) from code system "NCI Metathesaurus"
Value Set required NFDI4Health_VS_MDS_Study_Intervention_Type_NCI (version 2024‑01‑03 15:59:34)
description nfdhtfcov19-dataelement-226 |
Id | nfdhtfcov19-dataelement-226 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional information about the intervention
### Properties
Design.interventions.description | Design.interventions.description
Relationship | Specialization description ( - 2022‑11‑28)
Rationale | Description: If needed, additional descriptive information about the given intervention.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Value Domain | String
armsLabel nfdhtfcov19-dataelement-227 |
Id | nfdhtfcov19-dataelement-227 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Name(s) of the arm(s) associated with the given intervention
### Properties
Design.interventions.armsLabel | Design.interventions.armsLabel
Relationship | Specialization armsGroupsLabel ( - 2022‑11‑28)
Rationale | Description: Name(s) of the [RESOURCE] arm(s) associated with the given intervention.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*
Value Domain | String
exposures nfdhtfcov19-dataelement-228 | link
Id | nfdhtfcov19-dataelement-228 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-144 (2023‑12‑05 22:29:29)
Description | Exposures of the [RESOURCE]
### Properties
Design.exposures | Design.exposures
Rationale | Description: Group of items providing information about the exposures of the [RESOURCE].
Source | NFDI4Health
Comment | Additional information: Specification of the exposure(s) associated with each group.
Comment | Cardinality: 0..*, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Non-interventional') OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0
Comment | Cardinality: 0..*, if (Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign == 'C142615') OR Resource.classification.type == ('C61393' OR '178'); otherwise 0..0
name nfdhtfcov19-dataelement-229 |
Id | nfdhtfcov19-dataelement-229 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-145 (2023‑12‑05 22:34:08)
Description | Name of the exposure
### Properties
Design.exposures.name | Design.exposures.name
Rationale | Description: A short descriptive name of the exposure.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 1..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Operationalization | Short input help: If the same exposure is associated with more than one group, please provide the information once and use the field 'Name(s) of the group(s) associated with the given exposure' to associate it with more than one group.
Value Domain | String
type nfdhtfcov19-dataelement-230 |
Id | nfdhtfcov19-dataelement-230 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-146 (2023‑12‑05 22:36:30)
Description | Type of the exposure
### Properties
Design.exposures.type | Design.exposures.type
Rationale | Description: General type of the given exposure.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Drug (including placebo) |  | code "C1909" (Pharmacologic Substance) from code system "FDA RouteOfAdministration"
Device (including sham) |  | code "C62103" (Device) from code system "FDA RouteOfAdministration"
Biological/Vaccine |  | code "C923" (Vaccine) from code system "FDA RouteOfAdministration"
Procedure/Surgery |  | code "C79751" (Procedure) from code system "FDA RouteOfAdministration"
Radiation |  | code "C61398" (Radiation Exposure) from code system "FDA RouteOfAdministration"
Behavioral (e.g., psychotherapy, lifestyle counseling) |  | code "C181743" (Behavioral Counseling) from code system "FDA RouteOfAdministration"
Genetic (including gene transfer, stem cell and recombinant DNA) |  | code "C17938" (Genetic) from code system "FDA RouteOfAdministration"
Dietary supplement (e.g., vitamins, minerals) |  | code "C1505" (Dietary Supplement) from code system "FDA RouteOfAdministration"
Combination product (combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device) |  | code "C54696" (Combination Product) from code system "FDA RouteOfAdministration"
Diagnostic test (e.g., imaging, in-vitro) |  | code "C17454" (Diagnostic Test) from code system "FDA RouteOfAdministration"
Other |  | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Exposure_Type_NCI (version 2024‑01‑03 16:17:07)
description nfdhtfcov19-dataelement-231 |
Id | nfdhtfcov19-dataelement-231 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-147 (2023‑12‑05 22:43:25)
Description | Additional information about the exposure
### Properties
Design.exposures.description | Design.exposures.description
Rationale | Description: If needed, additional descriptive information about the given exposure.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Value Domain | String
groupsLabel nfdhtfcov19-dataelement-232 |
Id | nfdhtfcov19-dataelement-232 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-148 (2023‑12‑05 22:46:23)
Description | Name(s) of the group(s) associated with the given exposure
### Properties
Design.exposures.groupsLabel | Design.exposures.groupsLabel
Rationale | Description: Name(s) of the [RESOURCE] group(s) associated with the given exposure.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..*, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Value Domain | String
outcomes nfdhtfcov19-dataelement-233 | link
Id | nfdhtfcov19-dataelement-233 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Outcome measures in the [RESOURCE]
### Properties
Design.outcomes | Design.outcomes
Relationship | Specialization studyOutcomes ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about outcome measures.
Source | NFDI4Health
Comment | Additional information: The items are optional, especially for non-interventional studies.
Comment | Cardinality: 0..*
title nfdhtfcov19-dataelement-234 |
Id | nfdhtfcov19-dataelement-234 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Name of the outcome measure
### Properties
Design.outcomes.title | Design.outcomes.title
Relationship | Specialization title ( - 2022‑11‑28)
Rationale | Description: Name of the outcome measure. For non-interventional studies, this can be the name of specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1
Operationalization | Short input help: For non-interventional studies, you can provide specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
Value Domain | String
description nfdhtfcov19-dataelement-235 |
Id | nfdhtfcov19-dataelement-235 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Description of the outcome measure
### Properties
Design.outcomes.description | Design.outcomes.description
Relationship | Specialization description ( - 2022‑11‑28)
Rationale | Description: Additional descriptive information about the given outcome.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Value Domain | String
type nfdhtfcov19-dataelement-236 |
Id | nfdhtfcov19-dataelement-236 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Type of the outcome measure
### Properties
Design.outcomes.type | Design.outcomes.type
Relationship | Specialization type ( - 2022‑11‑28)
Rationale | Description: The type indicates the degree of importance of the outcome measure in the [RESOURCE].
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 1..1, if (Design.outcomes.title != Null OR Design.outcomes.description != Null); otherwise 0..0
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Primary | (1) The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s); (2) In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C98772" (Primary Outcome Measure) from code system "FDA RouteOfAdministration"
Secondary | (1) Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s); (2) In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C98781" (Secondary Outcome Measure) from code system "FDA RouteOfAdministration"
Other | Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Outcome_Type_NCI (version 2024‑01‑03 16:20:30)
timeFrame nfdhtfcov19-dataelement-237 |
Id | nfdhtfcov19-dataelement-237 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Time point(s) of assessment
### Properties
Design.outcomes.timeFrame | Design.outcomes.timeFrame
Relationship | Specialization timeFrame ( - 2022‑11‑28)
Rationale | Description: Description of the time point(s) at which the measurement for the outcome is assessed, e.g. the specific duration of time over which each participant is assessed.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
Value Domain | String
comment nfdhtfcov19-dataelement-238 |
Id | nfdhtfcov19-dataelement-238 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional information about the [RESOURCE]
### Properties
Design.comment | Design.comment
Relationship | Specialization comment ( - 2022‑11‑28)
Rationale | Description: Any additional information about specific aspects of the [RESOURCE] that could not be captured by other fields.
Source | NFDI4Health
Comment | Cardinality: 0..1
Operationalization | Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields.
Value Domain | String
assessments nfdhtfcov19-dataelement-239 |
Id | nfdhtfcov19-dataelement-239 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional assessments/measurements in the [RESOURCE]
### Properties
Design.assessments | Design.assessments
Relationship | Specialization assessments ( - 2022‑11‑28)
Rationale | Description: Any additional assessments/measurements included in the [RESOURCE].
Source | NFDI4Health ENPADASI [ https://academic.oup.com/jn/article/148/2/285/4913031]
Comment | Cardinality: 0..*
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Diet/Nutrition | Information about the consumption of food (e.g. type, quantity and frequency of food intake) and associated behaviours. Also see Dom. 7 'Medication and supplements', under 'Medication and supplement intake' for information about the consumption of vitamins and supplements [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "C16011" (Diet and Nutrition) from code system "FDA RouteOfAdministration"
Physical activity | Information about the type, frequency and intensity of physical activity such as exercises and sports (e.g. jogging, playing hockey), daily activities (e.g. household chores, walking the dog) or sedentarity (e.g. lounging on the couch) [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "398636004" (Physical activity assessment (procedure)) from code system "SNOMED Clinical Terms"
Tobacco use | Information about the consumption of tobacco in any form (e.g. quantity and frequency of smoking, chewing or sniffing) and associated behaviors [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "711013002" (Assessment of tobacco use (procedure)) from code system "SNOMED Clinical Terms"
Alcohol consumption | Information about the consumption of alcoholic beverages (e.g. frequency, quantity and type of alcohol consumed) and associated behaviors [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "713127001" (Assessment of alcohol use (procedure)) from code system "SNOMED Clinical Terms"
Body weight | The weight of a subject [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "39857003" (Weighing patient (procedure)) from code system "SNOMED Clinical Terms"
Body height | The distance from the base to the top of a subject's entire body [NIH Dietary Assessment Primer (https://dietassessmentprimer.cancer.gov/profiles/)]. | code "14456009" (Measuring height of patient (procedure)) from code system "SNOMED Clinical Terms"
Waist circumference | A circumferential measurement of the waist, which may be classified as the area immediately below the lowest rib, at the narrowest part of the torso, midpoint between the lowest rib and the iliac crest, or immediately above the iliac crest [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "445396007" (Measurement of circumference of waist (procedure)) from code system "SNOMED Clinical Terms"
Body Mass Index | An individual's weight in kilograms divided by the square of the height in meters [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "698094009" (Measurement of body mass index (procedure)) from code system "SNOMED Clinical Terms"
Body fat percentage | The amount of an individual's total body mass that is fat, expressed as a percent [NCIT (https://github.com/NCI-Thesaurus/thesaurus-obo-edition)]. | code "1230136007" (Method for determining body fat percentage (observable entity)) from code system "SNOMED Clinical Terms"
Sociodemographic information | Information about socio-demographic and economic characteristics [Maelstrom (doi: 10.1371/journal.pone.0200926)]. | code "C62699" (Study of Socioeconomic and Demographic Variables) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Assessments_SCT_NCI (version 2024‑01‑03 16:26:51)
dataSharingPlan nfdhtfcov19-dataelement-240 | link
Id | nfdhtfcov19-dataelement-240 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Data sharing strategy of the [RESOURCE]
### Properties
Design.dataSharingPlan | Design.dataSharingPlan
Relationship | Specialization dataSharingPlan ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the data sharing strategy of the [RESOURCE].
Source | NFDI4Health
Comment | Cardinality: 1..1
generally nfdhtfcov19-dataelement-241 |
Id | nfdhtfcov19-dataelement-241 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Is it planned to share the data?
### Properties
Design.dataSharingPlan.generally | Design.dataSharingPlan.generally
Relationship | Specialization generally ( - 2022‑11‑28)
Rationale | Description: Indication whether there is a plan to make data collected in the [RESOURCE] available. In case of a [RESOURCE] with patients or other individuals, this refers to individual participant data (IPD).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 1..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes, there is a plan to make data available |  | code "C49488" (Yes) from code system "FDA RouteOfAdministration"
No, there is no plan to make data available |  | code "C49487" (No) from code system "FDA RouteOfAdministration"
Undecided, it is not yet known if data will be made available |  | code "C150084" (Undecided) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Yes_No_Undecided_NCI (version 2024‑01‑03 16:33:17)
supportingInformation nfdhtfcov19-dataelement-242 |
Id | nfdhtfcov19-dataelement-242 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Supporting documents available in addition to the data
### Properties
Design.dataSharingPlan.supportingInformation | Design.dataSharingPlan.supportingInformation
Relationship | Specialization supportingInformation ( - 2022‑11‑28)
Rationale | Description: Supporting information/documents which will be made available in addition to the data collected in the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..*, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0
Comment | Cardinality: 0..*, if Design.dataSharingPlan.generally == 'C49488'; otherwise 0..0
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Data dictionary | A document describing the data, including metadata, and their meaning, usage, and relationship to other data [NFDI4Health]. | code "009" (Data dictionary) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Study protocol | The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study; intervention description, and method of data analysis [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C70817" (Study Protocol) from code system "FDA RouteOfAdministration"
Protocol amendment | A written description of a change(s) to, or formal clarification of, a protocol [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C132347" (Protocol Amendment) from code system "FDA RouteOfAdministration"
Statistical analysis plan | A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C115761" (Statistical Analysis Plan) from code system "FDA RouteOfAdministration"
Analytic code | A document that contains a code that extracts, manages, and analyses data [NFDI4Health]. | code "010" (Analytic code) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Informed consent form | A template of a document explaining all the relevant information to assist an individual in understanding the expectations and risks in making a decision about a procedure. This document is presented to and signed by the individual or guardian [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C16468" (Consent Form) from code system "FDA RouteOfAdministration"
Clinical study report | A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C142439" (Clinical study report) from code system "FDA RouteOfAdministration"
Manual of operations (SOP) | Detailed, written instructions to achieve uniformity of the performance of a specific function [EMA (European Medicines Agency - ICH: E 6 (R2): Guideline for good clinical practice - Step 5 (europa.eu))]. | code "C115779" (Standard Operating Procedure List (Intellectual Product)) from code system "FDA RouteOfAdministration"
Case report form (template) | A printed, optical, or electronic document designed to record all of the clinical study-required information stipulated in the protocol to be reported to the sponsor on each clinical trial subject [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C40988" (Case Report Form) from code system "FDA RouteOfAdministration"
Questionnaire (template) | Set of pre-determined questions presented to study participants [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "C17048" (Questionnaire) from code system "FDA RouteOfAdministration"
Code book | Pre-defined categorization scheme used for content coding, a data collection technique to transform qualitative data (textual, video, audio or still-image) originally produced for other purposes into quantitative data [DDI (https://ddialliance.org/Specification/DDI-CV/TypeOfInstrument_1.1.html)]. | code "011" (Codebook) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Other | A study document that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Supporting_Information_NCI_Local (version 2024‑01‑17 22:28:32)
timeFrame nfdhtfcov19-dataelement-243 |
Id | nfdhtfcov19-dataelement-243 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | When and for how long will the data be available?
### Properties
Design.dataSharingPlan.timeFrame | Design.dataSharingPlan.timeFrame
Relationship | Specialization timeFrame ( - 2022‑11‑28)
Rationale | Description: Indication of the time period for which the data and, if applicable, supporting documents will be made available.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0
Comment | Cardinality: 0..1, if Design.dataSharingPlan.generally == 'C49488'; otherwise 0..0
Value Domain | String
accessCriteria nfdhtfcov19-dataelement-244 |
Id | nfdhtfcov19-dataelement-244 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Criteria for data access
### Properties
Design.dataSharingPlan.accessCriteria | Design.dataSharingPlan.accessCriteria
Relationship | Specialization accessCriteria ( - 2022‑11‑28)
Rationale | Description: Indication of the access criteria by which the data will be shared, including: a) with whom; b) for which types of analyses; and c) by what mechanism.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1, if Design.dataSharingPlan.generally == 'Yes, there is a plan to make data available'; otherwise 0..0
Comment | Cardinality: 0..1, if Design.dataSharingPlan.generally == 'C49488'; otherwise 0..0
Operationalization | Short input help: Please provide here with whom, for which types of analyses and by what mechanism the data will be shared.
Value Domain | String
description nfdhtfcov19-dataelement-245 |
Id | nfdhtfcov19-dataelement-245 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional information about data sharing
### Properties
Design.dataSharingPlan.description | Design.dataSharingPlan.description
Relationship | Specialization description ( - 2022‑11‑28)
Rationale | Description: Additional descriptive information providing more details about data sharing, e.g. indication of which data in particular will be shared or why the data will not be shared or why it is not yet decided.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1
Operationalization | Short input help: Please indicate here which data in particular will be shared, or the reasons why it will not be shared or it is not yet decided.
Value Domain | String
datashield nfdhtfcov19-dataelement-246 |
Id | nfdhtfcov19-dataelement-246 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | DataSHIELD/Opal infrastructure available?
### Properties
Design.dataSharingPlan.datashield | Design.dataSharingPlan.datashield
Relationship | Specialization datashield ( - 2022‑11‑28)
Rationale | Description: Indication whether the DataSHIELD/Opal infrastructure is available.
Source | NFDI4Health
Comment | Cardinality: 0..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Pending |  | code "C53470" (Pending) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Data_Sharing_Plan_Datashield_SCT_NCI (version 2024‑01‑17 22:42:43)
requestData nfdhtfcov19-dataelement-247 |
Id | nfdhtfcov19-dataelement-247 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-149 (2023‑12‑07 09:56:48)
Description | Link to data request application
### Properties
Design.dataSharingPlan.requestData | Design.dataSharingPlan.requestData
Rationale | Description: If existing, a link to the web page where the data request form and/or information on data reuse can be found.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Data type in Excel version: url
Value Domain | String
url nfdhtfcov19-dataelement-248 |
Id | nfdhtfcov19-dataelement-248 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Web page with additional information about data sharing
### Properties
Design.dataSharingPlan.url | Design.dataSharingPlan.url
Relationship | Specialization url ( - 2022‑11‑28)
Rationale | Description: If existing, a link to the web page where additional information about data sharing can be found.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] Taichman DB, et al. [doi:10.1001/jama.2017.6514]
Comment | Cardinality: 0..1
Comment | Data type in Excel version: url
Value Domain | String
recordLinkage nfdhtfcov19-dataelement-249 |
Id | nfdhtfcov19-dataelement-249 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-150 (2023‑12‑07 09:59:45)
Description | Record linkage possible?
### Properties
Design.dataSharingPlan.recordLinkage | Design.dataSharingPlan.recordLinkage
Rationale | Description: Indication if record linkage with other data sources is possible.
Source | NFDI4Health UC 5.3 requirements
Comment | Additional information: Record linkage refers to the merging of data on the same person from different databases.
Comment | Cardinality: 1..1, if Resource.provenance.dataSource == 'Manually collected'; otherwise 0..0
Comment | Cardinality: 1..1, if Resource.provenance.dataSource == '06'; otherwise 0..0
Value Domain | Boolean
nonInterventional nfdhtfcov19-dataelement-250 | link
Id | nfdhtfcov19-dataelement-250 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Non-interventional aspects of the [RESOURCE]
### Properties
Design.nonInterventional | Design.nonInterventional
Relationship | Specialization nonInterventional ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about specific non-interventional aspects of the [RESOURCE].
Source | NFDI4Health
Comment | Additional information: Group of items applicable only to non-interventional resources.
Comment | Cardinality: 0..1, if (Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign == 'Non-interventional') OR Resource.classification.type == ('Registry' OR 'Secondary data source'); otherwise 0..0
Comment | Cardinality: 0..1, if (Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign == 'C142615') OR Resource.classification.type == ('C61393' OR '178'); otherwise 0..0
timePerspectives nfdhtfcov19-dataelement-251 |
Id | nfdhtfcov19-dataelement-251 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Temporal design
### Properties
Design.nonInterventional.timePerspectives | Design.nonInterventional.timePerspectives
Relationship | Specialization timePerspectives ( - 2022‑11‑28)
Rationale | Description: Temporal design of the [RESOURCE], i.e. the observation period in relation to the time of participant enrollment.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0
Comment | Cardinality: 0..*, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0
Operationalization | Short input help: Is it a retrospective, prospective or cross-sectional [RESOURCE]?
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Retrospective | Look back using observations collected predominantly prior to subject selection and enrollment [NFDI4Health]. | code "C53312" (Retrospective Study) from code system "FDA RouteOfAdministration"
Prospective | Look forward using periodic observations collected predominantly following subject enrollment [NFDI4Health]. | code "C142646" (Prospective Study) from code system "FDA RouteOfAdministration"
Cross-sectional | Observations or measurements made at a single point in time, usually at subject enrollment [NFDI4Health]. | code "C53310" (Cross-Sectional Study) from code system "FDA RouteOfAdministration"
Other | A time perspective that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Time_Perspectives_NCI (version 2024‑01‑18 12:23:06)
targetFollowUpDuration nfdhtfcov19-dataelement-252 | link
Id | nfdhtfcov19-dataelement-252 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-151 (2023‑12‑07 10:19:02)
Description | Target follow-up duration of the [RESOURCE]
### Properties
Design.nonInterventional.targetFollowUpDuration | Design.nonInterventional.targetFollowUpDuration
Rationale | Description: If applicable, anticipated time period over which each participant would be followed.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1
number nfdhtfcov19-dataelement-253 |
Id | nfdhtfcov19-dataelement-253 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-152 (2023‑12‑07 10:21:41)
Description | Target follow-up duration
### Properties
Design.nonInterventional.targetFollowUpDuration.number | Design.nonInterventional.targetFollowUpDuration.number
Rationale | Description: Numerical value of the target follow-up duration.
Comment | Cardinality: 1..1
Comment | Data type in Excel version: integer
Value Domain | Quantity
timeUnit nfdhtfcov19-dataelement-254 |
Id | nfdhtfcov19-dataelement-254 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-153 (2023‑12‑07 10:22:58)
Description | Unit of time
### Properties
Design.nonInterventional.targetFollowUpDuration.timeUnit | Design.nonInterventional.targetFollowUpDuration.timeUnit
Rationale | Description: Unit of measurement used to describe the follow-up duration.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 1..1
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Years |  | code "a" (year) from code system "UCUM"
Months |  | code "mo" (month) from code system "UCUM"
Weeks |  | code "we" (week) from code system "UCUM"
Days |  | code "d" (day) from code system "UCUM"
Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM (version 2024‑01‑18 12:34:55)
frequency nfdhtfcov19-dataelement-255 |
Id | nfdhtfcov19-dataelement-255 (2024‑03‑06 09:22:58)
Concept inherits from | nfdhtfcov19-dataelement-154 (2023‑12‑07 10:26:22)
Description | Number of follow-ups conducted
### Properties
Design.nonInterventional.targetFollowUpDuration.frequency | Design.nonInterventional.targetFollowUpDuration.frequency
Rationale | Description: The number of follow-ups conducted within the specified duration.
Source | NFDI4Health
Comment | Cardinality: 0..1
Comment | Data type in Excel version: integer
Value Domain | Quantity
biospecimenRetention nfdhtfcov19-dataelement-256 |
Id | nfdhtfcov19-dataelement-256 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Biosamples retained in a biorepository
### Properties
Design.nonInterventional.biospecimenRetention | Design.nonInterventional.biospecimenRetention
Relationship | Specialization biospecimenRetention ( - 2022‑11‑28)
Rationale | Description: Indication whether samples of biomaterials from participants of the [RESOURCE] are retained in a biorepository.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..*
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
None retained |  | code "C127776" (Biospecimens Not Retained) from code system "FDA RouteOfAdministration"
Samples with DNA |  | code "C127777" (Retained Specimens Contain DNA) from code system "FDA RouteOfAdministration"
Samples without DNA |  | code "C127778" (Retained Specimens Do Not Contain DNA) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Biospecimen_Retention_NCI (version 2024‑01‑18 11:54:42)
biospecimenDescription nfdhtfcov19-dataelement-257 |
Id | nfdhtfcov19-dataelement-257 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Specific types of retained biosamples
### Properties
Design.nonInterventional.biospecimenDescription | Design.nonInterventional.biospecimenDescription
Relationship | Specialization biospecimenDescription ( - 2022‑11‑28)
Rationale | Description: Additional information about retained biosamples, i.e. an indication of the specific types of retained biospecimens (e.g. blood, serum, urine, etc.).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1, if Design.nonInterventional.biospecimenRetention != 'None retained'; otherwise 0..0
Comment | Cardinality: 0..1, if Design.nonInterventional.biospecimenRetention != 'C127776'; otherwise 0..0
Operationalization | Short input help: You can provide here specific types of retained biosamples (e.g. blood, serum, urine, etc.).
Value Domain | String
Example | blood
interventional nfdhtfcov19-dataelement-258 | link
Id | nfdhtfcov19-dataelement-258 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Interventional aspects of the [RESOURCE]
### Properties
Design.interventional | Design.interventional
Relationship | Specialization interventional ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about specific interventional aspects of the [RESOURCE].
Source | NFDI4Health
Comment | Additional information: Group of items applicable only to interventional resources.
Comment | Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy') AND Design.primaryDesign =='Interventional'; otherwise 0..0
Comment | Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230') AND Design.primaryDesign =='C98388'; otherwise 0..0
phase nfdhtfcov19-dataelement-259 |
Id | nfdhtfcov19-dataelement-259 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Numerical phase
### Properties
Design.interventional.phase | Design.interventional.phase
Relationship | Specialization phase ( - 2022‑11‑28)
Rationale | Description: If applicable, numerical phase of the [RESOURCE].
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Early-phase-1 | Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies) [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C54721" (Phase 0 Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-1 | Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15600" (Phase I Trial) from code system "FDA RouteOfAdministration"
Phase-1-phase-2 | Trials that are a combination of phases 1 and 2 [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15693" (Phase I/II Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-2 | Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15601" (Phase II Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-2a | A clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49686" (Phase IIa Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-2b | A clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49688" (Phase II b Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-2-phase-3 | Trials that are a combination of phases 2 and 3 [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15694" (Phase II/III Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-3 | Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C15602" (Phase III Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-3a | A classification typically assigned retrospectively to a Phase-3 trial upon determination by regulatory authorities of a need for a Phase-3b trial [DRKS (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49687" (Phase IIIa Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-3b | A type of Phase-3 trial executed near the time of approval to elicit additional findings. This type of trial may be required as a condition of regulatory authority approval [DRKS (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields), NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C49689" (Phase IIIb Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Phase-4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use [DRKS (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields)]. | code "C15603" (Phase IV Trial (Research Activity)) from code system "FDA RouteOfAdministration"
Other | A phase that is not covered by any of the other values in this list [NFDI4Health]. | code "C17649" (Other (Qualitative Concept)) from code system "FDA RouteOfAdministration"
Not applicable | Trials without phases (for example, studies of devices or behavioral interventions) [NFDI4Health]. | code "C48660" (Not Applicable (Qualitative Concept)) from code system "FDA RouteOfAdministration"
Value Set NFDI4Health_VS_MDS_Study_Phase_NCI (version 2024‑01‑18 12:44:08)
masking nfdhtfcov19-dataelement-260 | link
Id | nfdhtfcov19-dataelement-260 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Masking of intervention(s) assignment
### Properties
Design.interventional.masking | Design.interventional.masking
Relationship | Specialization masking ( - 2022‑11‑28)
Rationale | Description: Group of items providing information about the masking of intervention(s) assignment.
Source | NFDI4Health
Comment | Cardinality: 0..1
general nfdhtfcov19-dataelement-261 |
Id | nfdhtfcov19-dataelement-261 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Masking implemented?
### Properties
Design.interventional.masking.general | Design.interventional.masking.general
Relationship | Specialization general ( - 2022‑11‑28)
Rationale | Description: Indication whether a masking (or blinding) of intervention(s) assignment is implemented (i.e., whether someone is prevented from having knowledge of the interventions assigned to individual participants).
Source | NFDI4Health CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Value Domain | Boolean
roles nfdhtfcov19-dataelement-262 |
Id | nfdhtfcov19-dataelement-262 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Who is masked?
### Properties
Design.interventional.masking.roles | Design.interventional.masking.roles
Relationship | Specialization roles ( - 2022‑11‑28)
Rationale | Description: If masking is implemented, the party(ies) who are masked.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..*, if Design.interventional.masking.general == true; otherwise 0..0
Operationalization | Short input help: Select all that apply.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Participant | Someone who takes part in an activity, e.g. a study [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C29867" (Participant) from code system "FDA RouteOfAdministration"
Care provider | A medical professional who provides, coordinates, or helps a patient access a range of health care services [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C16666" (Health Care Provider) from code system "FDA RouteOfAdministration"
Investigator | An individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures [NCI (GitHub - NCI-Thesaurus/thesaurus-obo-edition: OBO Library edition of NCIt)]. | code "C25936" (Investigator) from code system "FDA RouteOfAdministration"
Outcomes assessor | Outcomes accessor is an individual who evaluates the outcome(s) of interest, e.g. a statistician [NFDI4Health]. | code "012" (Outcomes assessor) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Value Set NFDI4Health_VS_MDS_Study_Masking_Roles_NCI_Local (version 2024‑01‑19 10:55:01)
description nfdhtfcov19-dataelement-263 |
Id | nfdhtfcov19-dataelement-263 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Additional information about masking
### Properties
Design.interventional.masking.description | Design.interventional.masking.description
Relationship | Specialization description ( - 2022‑11‑28)
Rationale | Description: If needed, additional descriptive information about masking (e.g. information about other parties who may be masked).
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]
Comment | Cardinality: 0..1, if Design.interventional.masking.general == true; otherwise 0..0
Operationalization | Short input help: You can provide here additional information about masking, e.g. other parties who may be masked.
Value Domain | String
allocation nfdhtfcov19-dataelement-264 |
Id | nfdhtfcov19-dataelement-264 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Type of allocation of participants to an arm
### Properties
Design.interventional.allocation | Design.interventional.allocation
Relationship | Specialization allocation ( - 2022‑11‑28)
Rationale | Description: Type of allocation/assignment of individual participants of the [RESOURCE] to an arm.
Source | CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary] DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Operationalization | Short input help: Select one value from the list.
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Randomized | A type of allocation strategy in which participants are assigned to the arms/groups of a clinical trial by chance [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C0034656" (Randomization) from code system "FDA RouteOfAdministration"
Nonrandomized | A type of allocation strategy in which participants are not assigned to the arms/groups of a clinical trial by chance [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C93043" (Nonrandomized Clinical Trial) from code system "FDA RouteOfAdministration"
Not applicable (for single-arm trials) | Trials with just single arm [CT.gov (https://prsinfo.clinicaltrials.gov/definitions.html, https://www.clinicaltrials.gov/ct2/about-studies/glossary)]. | code "C48660" (Not Applicable) from code system "FDA RouteOfAdministration"
Value Set required NFDI4Health_VS_MDS_Study_Allocation_NCI (version 2024‑01‑18 13:19:48)
offLabelUse nfdhtfcov19-dataelement-265 |
Id | nfdhtfcov19-dataelement-265 (2024‑03‑06 09:22:58)
Concept inherits from | (2023‑12‑04)
Description | Off-label use of a drug product
### Properties
Design.interventional.offLabelUse | Design.interventional.offLabelUse
Relationship | Specialization offLabelUse ( - 2022‑11‑28)
Rationale | Description: Unapproved (off-label) use of a drug product.
Source | DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]
Comment | Cardinality: 0..1
Operationalization | Short input help: Select 'Yes' or 'No' only for a drug [RESOURCE] and 'Not applicable' for any other [RESOURCE].
Value Domain | Code
Choice list |
Concept List
Concept | Description | Assigned references
Yes |  | code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
No |  | code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
Not applicable |  | code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
Value Set required NFDI4Health_VS_MDS_Yes_No_Not_Applicable_SNOMEDCT (version 2023‑08‑28 21:57:28)