| Name |
Details [‑] |
|
  Design
nfdhtfcov19-dataelement-155
|
|
|
| Id |
nfdhtfcov19-dataelement-155 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
 (2023‑12‑04)
|
| Description |
Characteristics of the [RESOURCE]
|
|
|
| Relationship |
|
| 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]?
|
| Design.primaryDesign |
Design.primaryDesign
|
|
| Relationship |
|
| 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
|
|
|
|
|
| interventional
nfdhtfcov19-dataelement-158
|
|
|
|
|
| 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
|
| Design.studyType.nonInterventional |
Design.studyType.nonInterventional
|
|
| Relationship |
|
| 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
|
|
|
| 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]
|
| Design.conditions |
Design.conditions
|
|
| Relationship |
|
| 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
|
|
|
|
|
| classification
nfdhtfcov19-dataelement-162
|
|
|
| Id |
nfdhtfcov19-dataelement-162 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Terminology/classification
|
| Design.conditions.classification |
Design.conditions.classification
|
|
| Relationship |
|
| 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
|
| Design.conditions.code |
Design.conditions.code
|
|
| Relationship |
|
| 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
|
|
|
| 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]
|
| 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
|
|
|
|
|
| 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
|
| 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
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-168 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Groups of diseases or conditions
|
| Design.groupsOfDiseases |
Design.groupsOfDiseases
|
|
| Relationship |
|
| 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?
|
| Design.groupsOfDiseases.generally |
Design.groupsOfDiseases.generally
|
|
| Relationship |
|
| 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?
|
| Design.groupsOfDiseases.conditions |
Design.groupsOfDiseases.conditions
|
|
| Relationship |
|
| 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 |
|
|
|
| mortalityData
nfdhtfcov19-dataelement-171
|
|
|
| Id |
nfdhtfcov19-dataelement-171 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Collects mortality data?
|
| Design.mortalityData |
Design.mortalityData
|
|
| Relationship |
|
| 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
|
|
|
| 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]
|
| 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
|
| Design.administrativeInformation.ethicsCommitteeApproval |
Design.administrativeInformation.ethicsCommitteeApproval
|
|
| Relationship |
|
| 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
|
| Design.administrativeInformation.status |
Design.administrativeInformation.status
|
|
| Relationship |
|
| 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?
|
| Design.administrativeInformation.statusWhenIntervention |
Design.administrativeInformation.statusWhenIntervention
|
|
| Relationship |
|
| 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
|
| Design.administrativeInformation.stageStopped |
Design.administrativeInformation.stageStopped
|
|
| Relationship |
|
| 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
|
| Design.administrativeInformation.reasonStopped |
Design.administrativeInformation.reasonStopped
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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
|
| Design.administrativeInformation.recruitmentStatusRegister |
Design.administrativeInformation.recruitmentStatusRegister
|
|
| Relationship |
|
| 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
|
|
|
|
|
| endDate
nfdhtfcov19-dataelement-181
|
|
|
|
|
| centers
nfdhtfcov19-dataelement-182
|
|
|
|
|
| centersNumber
nfdhtfcov19-dataelement-183
|
|
|
|
|
| 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?
|
| 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
|
| 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
|
| Design.subject |
Design.subject
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-187 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Sampling method
|
| Design.sampling |
Design.sampling
|
|
| Relationship |
|
| 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
|
| Design.sampling.method |
Design.sampling.method
|
|
| Relationship |
|
| 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
|
| Design.sampling.probabilityMethod |
Design.sampling.probabilityMethod
|
|
| Relationship |
|
| 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
|
| Design.sampling.nonProbabilityMethod |
Design.sampling.nonProbabilityMethod
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-191 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Data sources of the [RESOURCE]
|
| Design.dataSource |
Design.dataSource
|
|
| Relationship |
|
| 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
|
| Design.dataSource.general |
Design.dataSource.general
|
|
| Relationship |
|
| 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
|
| Design.dataSource.biosamples |
Design.dataSource.biosamples
|
|
| Relationship |
|
| 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
|
| Design.dataSource.imaging |
Design.dataSource.imaging
|
|
| Relationship |
|
| 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
|
| Design.dataSource.omics |
Design.dataSource.omics
|
|
| Relationship |
|
| 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
|
| Design.dataSource.description |
Design.dataSource.description
|
|
| Relationship |
|
| 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]
|
| Design.primaryPurpose |
Design.primaryPurpose
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-198 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Eligibility criteria for [RESOURCE] participants
|
| Design.eligibilityCriteria |
Design.eligibilityCriteria
|
|
| Relationship |
|
| Rationale |
Description: Group of items providing information about eligibility criteria for [RESOURCE] participants.
|
| Source |
NFDI4Health |
| Comment |
Cardinality: 0..1
|
|
|
| ageMin
nfdhtfcov19-dataelement-199
|
|
|
| Id |
nfdhtfcov19-dataelement-199 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Eligibility criteria: Minimum age
|
| Design.eligibilityCriteria.ageMin |
Design.eligibilityCriteria.ageMin
|
|
| Relationship |
|
| 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
|
|
|
|
|
| timeUnit
nfdhtfcov19-dataelement-201
|
|
|
|
|
| ageMax
nfdhtfcov19-dataelement-202
|
|
|
| Id |
nfdhtfcov19-dataelement-202 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Eligibility criteria: Maximum age
|
| Design.eligibilityCriteria.ageMax |
Design.eligibilityCriteria.ageMax
|
|
| Relationship |
|
| 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
|
|
|
|
|
| timeUnit
nfdhtfcov19-dataelement-204
|
|
|
|
|
| genders
nfdhtfcov19-dataelement-205
|
|
|
|
|
| inclusionCriteria
nfdhtfcov19-dataelement-206
|
|
|
|
|
| exclusionCriteria
nfdhtfcov19-dataelement-207
|
|
|
|
|
| population
nfdhtfcov19-dataelement-208
|
|
|
| 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]
|
| 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
|
| 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
|
|
|
|
|
| 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)
|
| Design.population.region |
Design.population.region
|
|
| Relationship |
|
| 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
|
|
|
|
|
| targetSampleSize
nfdhtfcov19-dataelement-213
|
|
|
|
|
| obtainedSampleSize
nfdhtfcov19-dataelement-214
|
|
|
|
|
| hypothesis
nfdhtfcov19-dataelement-215
|
|
|
| Id |
nfdhtfcov19-dataelement-215 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Research questions/hypotheses
|
| Design.hypotheses |
Design.hypotheses
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-216 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Arms of the [RESOURCE]
|
|
|
| Relationship |
|
| 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
|
|
|
|
|
| type
nfdhtfcov19-dataelement-218
|
|
|
|
|
| description
nfdhtfcov19-dataelement-219
|
|
|
|
|
| groups
nfdhtfcov19-dataelement-220
|
|
|
| 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]
|
| 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
|
|
|
|
|
| description
nfdhtfcov19-dataelement-222
|
|
|
|
|
| interventions
nfdhtfcov19-dataelement-223
|
|
|
| Id |
nfdhtfcov19-dataelement-223 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Interventions of the [RESOURCE]
|
| Design.interventions |
Design.interventions
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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
|
| Design.interventions.type |
Design.interventions.type
|
|
| Relationship |
|
| 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
|
|
|
|
|
| armsLabel
nfdhtfcov19-dataelement-227
|
|
|
|
|
| exposures
nfdhtfcov19-dataelement-228
|
|
|
| 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]
|
| 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
|
| 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
|
| 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
|
|
|
|
|
| groupsLabel
nfdhtfcov19-dataelement-232
|
|
|
|
|
| outcomes
nfdhtfcov19-dataelement-233
|
|
|
| Id |
nfdhtfcov19-dataelement-233 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Outcome measures in the [RESOURCE]
|
| Design.outcomes |
Design.outcomes
|
|
| Relationship |
|
| 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
|
| Design.outcomes.title |
Design.outcomes.title
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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
|
| Design.outcomes.type |
Design.outcomes.type
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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]
|
| Design.comment |
Design.comment
|
|
| Relationship |
|
| 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]
|
| Design.assessments |
Design.assessments
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-240 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Data sharing strategy of the [RESOURCE]
|
| Design.dataSharingPlan |
Design.dataSharingPlan
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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
|
| Design.dataSharingPlan.supportingInformation |
Design.dataSharingPlan.supportingInformation
|
|
| Relationship |
|
| 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?
|
| Design.dataSharingPlan.timeFrame |
Design.dataSharingPlan.timeFrame
|
|
| Relationship |
|
| 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
|
| Design.dataSharingPlan.accessCriteria |
Design.dataSharingPlan.accessCriteria
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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?
|
| Design.dataSharingPlan.datashield |
Design.dataSharingPlan.datashield
|
|
| Relationship |
|
| 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
|
| 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
|
|
|
|
|
| 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?
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-250 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Non-interventional aspects of the [RESOURCE]
|
| Design.nonInterventional |
Design.nonInterventional
|
|
| Relationship |
|
| 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
|
| Design.nonInterventional.timePerspectives |
Design.nonInterventional.timePerspectives
|
|
| Relationship |
|
| 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
|
|
|
|
|
| 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
|
| 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
|
|
|
|
|
| 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
|
| 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
|
| Design.nonInterventional.biospecimenRetention |
Design.nonInterventional.biospecimenRetention
|
|
| Relationship |
|
| 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
|
| Design.nonInterventional.biospecimenDescription |
Design.nonInterventional.biospecimenDescription
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-258 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Interventional aspects of the [RESOURCE]
|
| Design.interventional |
Design.interventional
|
|
| Relationship |
|
| 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
|
| Design.interventional.phase |
Design.interventional.phase
|
|
| Relationship |
|
| 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
|
|
|
| Id |
nfdhtfcov19-dataelement-260 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Masking of intervention(s) assignment
|
| Design.interventional.masking |
Design.interventional.masking
|
|
| Relationship |
|
| Rationale |
Description: Group of items providing information about the masking of intervention(s) assignment.
|
| Source |
NFDI4Health |
| Comment |
Cardinality: 0..1
|
|
|
| general
nfdhtfcov19-dataelement-261
|
|
|
|
|
| roles
nfdhtfcov19-dataelement-262
|
|
|
| Id |
nfdhtfcov19-dataelement-262 (2024‑03‑06 09:22:58)
|
| Concept inherits from |
(2023‑12‑04)
|
| Description |
Who is masked?
|
| Design.interventional.masking.roles |
Design.interventional.masking.roles
|
|
| Relationship |
|
| 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
|
| Design.interventional.masking.description |
Design.interventional.masking.description
|
|
| Relationship |
|
| 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
|
|
|
|
|
| offLabelUse
nfdhtfcov19-dataelement-265
|
|
|
|
|