Group of items relevant for studies, substudies, registries and/or secondary data
sources, including details on targeted health conditions, study population, outcome
measures, and study design.
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
Used by
one transaction, 0 templates, inherited 0 times
This concept is used in transaction NFDI4Health Resource (3.3.1) (0 … 1 Conditional) in scenario Design3.3 (v3.3)
primaryDesign Conditional
Id
(2024‑12‑06 11:28:40)
Cardinality
Conditional
Card/Conf
Condition
1 … 1 Mandatory
1..1, if Resource.classification.type == ("Study" OR "Substudy")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Study" OR "Substudy")
Description
Is the study design non-interventional or 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"
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"
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"
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-sectional
(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-sectional 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"
Register study
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"
The disease, disorder, syndrome, illness, or injury that is being studied. Conditions
may also include other health-related issues, such as lifespan, quality of life, and
health risks.
Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT, ICD,
etc.) is preferred. However, also self-assigned terms are allowed.
Comment
Cardinality: 1..1
Operationalization
Preferably, use terms from terminologies such as SNOMED CT.
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"
Additional information: The use of terms from established terminologies/classifications (e.g. SNOMED CT,
ICD, etc.) is preferred. However, also self-assigned terms are allowed.
Comment
Cardinality: 1..1
Operationalization
Preferably, use terms from terminologies such as SNOMED CT.
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"
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
Select all that apply.
For more information about the ICD-10 codings of groups of diseases/conditions, visit
the WHO's ICD-10 homepage: https://icd.who.int/en.
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
Select all that apply.
Values are based on lower level ICD-10 codes. For more information visit the WHO's
ICD-10 homepage: https://icd.who.int/en.
This concept is inherited by concept conditions in dataset Module Radiomics (3.4)
This concept is inherited by concept conditions in dataset Module Design (3.4)
mortalityData Conditional
Id
(2024‑12‑06 11:28:40)
Cardinality
Conditional
Card/Conf
Condition
0 … 1
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")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND
Design.studyType.nonInterventional != ("Longitudinal" OR "Cohort" OR "Case-cohort"
OR "Birth cohort" OR "Trend" OR "Panel")
Indication whether mortality data are collected in the [RESOURCE].
Source
NFDI4Health
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
Additional information: If at least one study site in a multicenter study has the status 'Ongoing', then the
overall status of the study 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
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"
This concept is used in transaction NFDI4Health Resource (3.3.1) (0 … 1 Conditional) in scenario Design3.3 (v3.3)
This concept is inherited by concept status in dataset Module Design (3.4)
statusWhenIntervention Conditional
Id
(2024‑12‑06 11:28:40)
Cardinality
Conditional
Card/Conf
Condition
0 … 1
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")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign
!= "Interventional" OR 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")
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
This concept is used in transaction NFDI4Health Resource (3.3.1) (0 … 1 Conditional) in scenario Design3.3 (v3.3)
This concept is inherited by concept statusWhenIntervention in dataset Module Design (3.4)
stageStopped Conditional
Id
(2024‑12‑06 11:28:40)
Cardinality
Conditional
Card/Conf
Condition
0 … 1
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")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR 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")
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
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"
This concept is used in transaction NFDI4Health Resource (3.3.1) (0 … 1 Conditional) in scenario Design3.3 (v3.3)
This concept is inherited by concept stageStopped in dataset Module Design (3.4)
reasonStopped Conditional
Id
(2024‑12‑06 11:28:40)
Cardinality
Conditional
Card/Conf
Condition
0 … 1
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")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR 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")
Specification of the reasons why the [RESOURCE] was prematurely stopped, for example
due to toxicity, closed due to lack of study progress, temporarily closed per study
design.
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
Specify the reason why the [RESOURCE] was prematurely stopped.
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
In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of
a completed [RESOURCE], enter the actual end date.
In case of a [RESOURCE] with patients or other participants, it is the date when the
last participant is examined or receives an intervention, or the date of the last
participant’s last visit.
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
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"
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"
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"
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"
If needed, additional descriptive information about the data sources of the [RESOURCE],
for example indication of data sources 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
You can indicate here other data sources not listed in the field 'Types of data sources'
or provide a more detailed description of the selected data sources.
Foremost for interventional studies, please specify the primary purpose why the study
was conducted. For non-interventional studies, this field may be 'Not applicable'
as multiple purposes may be defined as primary ones.
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
Specification of the main purpose of the [RESOURCE].
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"
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"
Additional information: In the case of cohort studies, further participant ages can be indicated in the fields
'Inclusion criteria' or 'Exclusion criteria'.
Comment
Cardinality: 1..1
Comment
Data type in Excel version: integer
Operationalization
If age is less than 1 year, please indicate a value in months, weeks, days, hours,
minutes, or weeks of gestation.
Additional information: In the case of cohort studies, further participant ages can be indicated in the fields
'Inclusion criteria' or 'Exclusion criteria'.
Comment
Cardinality: 1..1
Comment
Data type in Excel version: integer
Operationalization
Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours,
minutes, or weeks of gestation.
Additional information: 'Arm' means a pre-specified group or subgroup of participants in the [RESOURCE] assigned
to receive specific intervention(s) (or no intervention) according to a protocol.
Additional information: If needed, additional descriptive information (including which interventions are administered
in each arm) to differentiate each arm from other arms in the [RESOURCE].
Additional information: Explanation of the nature of the group of participants (for example, participants
with and without a condition, participants with and without an exposure, etc.).
If the same intervention is associated with more than one arm, please provide the
information once and use the field 'Name(s) of the arm(s) associated with the given
intervention' to associate it with more than one arm.
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"
0..*, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Non-interventional") OR Resource.classification.type == ("Registry" OR "Secondary
data source")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND
Design.primaryDesign != "Non-interventional"
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
Used by
one transaction, 0 templates, inherited once
This concept is used in transaction NFDI4Health Resource (3.3.1) (0 … * Conditional) in scenario Design3.3 (v3.3)
This concept is inherited by concept exposures in dataset Module Design (3.4)
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
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.
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"
Name of the outcome measure.
For non-interventional studies, this can be the name of specific measurements or observations
used to describe patterns of diseases or traits or associations with exposures, risk
factors or treatment.
For non-interventional studies, you can provide specific measurements or observations
used to describe patterns of diseases or traits or associations with exposures, risk
factors or treatment.
(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"
Description of the time point(s) at which the measurement for the outcome is assessed,
for example the specific duration of time over which each participant is assessed.
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"
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"
Indication whether there is a plan to make data collected in the [RESOURCE] available.
In case of a [RESOURCE] with patients or other individuals, this refers to individual
participant data (IPD).
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"
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"
Additional descriptive information providing more details about data sharing, for
example indication of which data in particular will be shared or why the data will
not be shared or why it is not yet decided.
0..1, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Non-interventional") OR Resource.classification.type == ("Registry" OR "Secondary
data source")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND
Design.primaryDesign != "Non-interventional"
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
Used by
one transaction, 0 templates, inherited once
This concept is used in transaction NFDI4Health Resource (3.3.1) (0 … 1 Conditional) in scenario Design3.3 (v3.3)
This concept is inherited by concept nonInterventional in dataset Module Design (3.4)
timePerspectives Conditional
Id
(2024‑12‑06 11:28:40)
Cardinality
Conditional
Card/Conf
Condition
0 … *
0..*, if Resource.classification.type == ("Study" OR "Substudy")
0 … 0 Not permitted
0..0, if Resource.classification.type != ("Study" OR "Substudy")
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"
Indication whether a masking (or blinding) of intervention(s) assignment is implemented
(i.e., whether someone is prevented from having knowledge of the interventions assigned
to individual participants).
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"
Transaction NFDI4Health Resource 2.16.840.1.113883.3.1937.777.64.4.28
Design Conditional
Used by
