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draft Data Set Module Radiomics (3.4) 2.16.840.1.113883.3.1937.777.64.1.10

Name Id
draft Module Radiomics (3.4) 2.16.840.1.113883.3.1937.777.64.1.10
Effective date Expiration date
2025‑01‑31 13:58:00
Description

Group of items providing information on imaging data.

Name Details [‑]
folder draft Radiomics
nfdhtfcov19-dataelement-359
Id nfdhtfcov19-dataelement-359 (2025‑02‑03 13:17:30)
Description

Information about imaging data for the [RESOURCE]

Rationale

Group of items providing information on imaging data.

Source

NFDI4Health

Comment

1..1, if Design.dataSource.general == 'Imaging data'; otherwise 0..0

draft modalities
nfdhtfcov19-dataelement-391
Id nfdhtfcov19-dataelement-391 (2025‑03‑25 11:18:00)
Description

Image modalities (DICOM)

Rationale

Image modalities that were collected in the [RESOURCE].

Source

NFDI4Health

FHIR ValueSet 'Modality' published by NEMA MITA DICOM: https://simplifier.net/packages/fhir.dicom/2024.2.20240331/files/2386836

Comment

Cardinality: 1..*

Comment

Additional information: The FHIR ValueSet 'Modality' comprises acquisition (e.g. CT, MR, US) and non-acquisition (e.g. REG, SEG, SR) modalities from Part 16 of the current edition of the DICOM standard: https://www.dicomstandard.org/current

Operationalization

Select all that apply.

Example: [ MR, US, SR ]

Value Domain Code
Choice list
Concept List

Value Set required Modality (version 2025‑03‑26 15:54:34)
folder rejected modalities
nfdhtfcov19-dataelement-387
Id nfdhtfcov19-dataelement-387 (2025‑02‑07 16:09:43)
Description modalities
rejected acquisition
nfdhtfcov19-dataelement-388
Id nfdhtfcov19-dataelement-388 (2025‑02‑07 16:10:26)
Description acquisition
Value Domain Code
rejected nonAcquisition
nfdhtfcov19-dataelement-389
Id nfdhtfcov19-dataelement-389 (2025‑02‑07 16:11:15)
Description nonAcquisition
Value Domain Code
cancelled imagingModalities
nfdhtfcov19-dataelement-360
Id nfdhtfcov19-dataelement-360 (2025‑02‑03 13:19:02)
Description modalities
Value Domain Code
draft bodyPartsExamined
nfdhtfcov19-dataelement-361
Id nfdhtfcov19-dataelement-361 (2025‑02‑03 13:35:15)
Description

Body parts examined

Rationale

Information which body parts are imaged within the [RESOURCE].

Source

NFDI4Health

NEMA MITA DICOM

SNOMED Clinical Terms by SNOMED International

Comment

Cardinality 1..*

Comment

Additional Information: Correspondence between DICOM and SNOMED CT code values: https://dicom.nema.org/medical/dicom/current/output/chtml/part16/chapter_L.html#chapter_L

Operationalization

Select all that apply.

Example:

[ ABDOMEN, BRAIN, CHEST ] with DICOM code values

[ 818981001, 12738006, 43799004 ] with SNOMED CT code values

Value Domain Code
Choice list
Concept List

Value Set required BodyStructures (version 2025‑03‑26 16:03:04)
folder rejected groupsOfDiseases
nfdhtfcov19-dataelement-383
Id nfdhtfcov19-dataelement-383 (2025‑02‑03 14:33:18)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Groups of diseases or conditions

Properties

Design.groupsOfDiseases

Design.groupsOfDiseases

Relationship
Rationale

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

rejected generally
nfdhtfcov19-dataelement-384
Id nfdhtfcov19-dataelement-384 (2025‑02‑03 14:33:45)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Which groups of diseases or conditions were the data collected on?

Properties

Design.groupsOfDiseases.generally

Design.groupsOfDiseases.generally

Relationship
Rationale

General groups of diseases or conditions on which the data were collected.

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

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.

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)
rejected conditions
nfdhtfcov19-dataelement-385
Id nfdhtfcov19-dataelement-385 (2025‑02‑03 14:33:45)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

On which diseases or conditions were the data collected?

Properties

Design.groupsOfDiseases.conditions

Design.groupsOfDiseases.conditions

Relationship
Rationale

Diseases or conditions on which the data were collected in the [RESOURCE].

Source

ICD-10 [ https://icd.who.int/browse10/2019/en]

NFDI4Health

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

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.

Value Domain Code
Choice list
Concept List
Concept Description
Lower level ICD-10 (https://icd.who.int/browse10/2019/en), with autocomplete

Value Set required NFDI4Health_VS_MDS_Study_Groups_Of_Diseases_Generally_Conditions_ICD10 (version 2024‑03‑01 13:36:49)
rejected centers
nfdhtfcov19-dataelement-386
Id nfdhtfcov19-dataelement-386 (2025‑02‑03 14:35:01)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Mono- or multicentric?

Properties

Design.centers

Design.centers

Relationship
Rationale

Specification whether the data are collected at only one or at more than one study center.

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0

Comment

Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Monocentric
code "084" (Monocentric) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Multicentric
code "255206009" (Multicentric (qualifier value)) from code system "SNOMED Clinical Terms"

Value Set required NFDI4Health_VS_MDS_Study_Centers_SNOMEDCT_Local (version 2023‑08‑28 23:15:07)
cancelled groupsOfDiseases
nfdhtfcov19-dataelement-362
Id nfdhtfcov19-dataelement-362 (2025‑02‑03 13:55:22)
Description diseases
Value Domain Code
cancelled centers
nfdhtfcov19-dataelement-363
Id nfdhtfcov19-dataelement-363 (2025‑02‑03 14:07:32)
Description centers
Value Domain String
folder rejected eligibilityCriteria
nfdhtfcov19-dataelement-373
Id nfdhtfcov19-dataelement-373 (2025‑02‑03 14:30:32)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Eligibility criteria

Properties

Design.eligibilityCriteria

Design.eligibilityCriteria

Relationship
Rationale

Group of items providing information about eligibility criteria for participants.

Source NFDI4Health
Comment

Cardinality: 0..1

folder rejected ageMin
nfdhtfcov19-dataelement-374
Id nfdhtfcov19-dataelement-374 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Eligibility criteria: Minimum age

Properties

Design.eligibilityCriteria.ageMin

Design.eligibilityCriteria.ageMin

Relationship
Rationale

Group of items providing information about the minimum eligible age of participants.

Source NFDI4Health
Comment

Cardinality: 0..1

rejected number
nfdhtfcov19-dataelement-375
Id nfdhtfcov19-dataelement-375 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Minimum eligible age

Properties

Design.eligibilityCriteria.ageMin.number

Design.eligibilityCriteria.ageMin.number

Relationship
Rationale

Numerical value of the minimum age of potential participants eligible to participate in the [RESOURCE].

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'.

Comment

Cardinality: 1..1

Comment

Data type in Excel version: integer

Operationalization

If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.

Value Domain Quantity
rejected timeUnit
nfdhtfcov19-dataelement-376
Id nfdhtfcov19-dataelement-376 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Unit of age

Properties

Design.eligibilityCriteria.ageMin.timeUnit

Design.eligibilityCriteria.ageMin.timeUnit

Relationship
Rationale

Unit of measurement used to describe the minimum eligible age.

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 1..1

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Years
code "a" (year) from code system "UCUM"
Months
code "mo" (month) from code system "UCUM"
Weeks
code "we" (week) from code system "UCUM"
Days
code "d" (day) from code system "UCUM"
Hours
code "h" (hour) from code system "UCUM"
Minutes
code "min" (minute) from code system "UCUM"
Weeks of gestation
code "49051-6" (Gestational age in weeks) from code system "LOINC"

Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (version 2024‑01‑05 14:59:31)
folder rejected ageMax
nfdhtfcov19-dataelement-377
Id nfdhtfcov19-dataelement-377 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Eligibility criteria: Maximum age

Properties

Design.eligibilityCriteria.ageMax

Design.eligibilityCriteria.ageMax

Relationship
Rationale

Group of items providing information about the maximum eligible age of participants.

Source NFDI4Health
Comment

Cardinality: 0..1

rejected number
nfdhtfcov19-dataelement-378
Id nfdhtfcov19-dataelement-378 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Maximum eligible age

Properties

Design.eligibilityCriteria.ageMax.number

Design.eligibilityCriteria.ageMax.number

Relationship
Rationale

Description: Numerical value of the maximum age of potential participants eligible to participate in the [RESOURCE].

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Additional information: In the case of cohort studies, further participant ages can be indicated in the fields 'Inclusion criteria' or 'Exclusion criteria'.

Comment

Cardinality: 1..1

Comment

Data type in Excel version: integer

Operationalization

Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.

Value Domain Quantity
rejected timeUnit
nfdhtfcov19-dataelement-379
Id nfdhtfcov19-dataelement-379 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Unit of age

Properties

Design.eligibilityCriteria.ageMax.timeUnit

Design.eligibilityCriteria.ageMax.timeUnit

Relationship
Rationale

Description: Unit of measurement used to describe the maximum eligible age.

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 1..1

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Years
code "a" (year) from code system "UCUM"
Months
code "mo" (month) from code system "UCUM"
Weeks
code "we" (week) from code system "UCUM"
Days
code "d" (day) from code system "UCUM"
Hours
code "h" (hour) from code system "UCUM"
Minutes
code "min" (minute) from code system "UCUM"
Weeks of gestation
code "49051-6" (Gestational age in weeks) from code system "LOINC"

Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (version 2024‑01‑05 14:59:31)
rejected genders
nfdhtfcov19-dataelement-380
Id nfdhtfcov19-dataelement-380 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Eligible gender

Properties

Design.eligibilityCriteria.genders

Design.eligibilityCriteria.genders

Relationship
Rationale

Gender of potential participants eligible to participate in the [RESOURCE].

Source

NFDI4Health

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 0..*

Operationalization

Select all that apply. If no gender was explicitly excluded in the [RESOURCE], 'Male', 'Female', and 'Diverse' should be selected.

Value Domain Code
Choice list
Concept List
Concept Description Assigned references
Male
code "248153007" (Male) from code system "http://hl7.org/fhir/administrative-gender"
Female
code "248152002" (Female) from code system "http://hl7.org/fhir/administrative-gender"
Diverse
code "105" (Diverse) from code system "NFDI4Health_CS_MDS_Remaining_Concepts"
Not applicable
code "385432009" (Not applicable) from code system "http://hl7.org/fhir/administrative-gender"

Value Set NFDI4Health_VS_MDS_Study_Eligibility_Gender_SNOMEDCT_Local (version 2023‑08‑29 14:35:27)
rejected inclusionCriteria
nfdhtfcov19-dataelement-381
Id nfdhtfcov19-dataelement-381 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Inclusion criteria

Properties

Design.eligibilityCriteria.inclusionCriteria

Design.eligibilityCriteria.inclusionCriteria

Relationship
Rationale

Inclusion criteria for participation in the [RESOURCE].

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 0..1

Operationalization

If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.

Value Domain String
Example - First inclusion criterion; - Second inclusion criterion;
rejected exclusionCriteria
nfdhtfcov19-dataelement-382
Id nfdhtfcov19-dataelement-382 (2025‑02‑03 14:31:44)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Exclusion criteria

Properties

Design.eligibilityCriteria.exclusionCriteria

Design.eligibilityCriteria.exclusionCriteria

Relationship
Rationale

Exclusion criteria for participation in the [RESOURCE].

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 0..1

Operationalization

If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.

Value Domain String
Example - First inclusion criterion; - Second inclusion criterion;
folder cancelled eligibilityCriteria
nfdhtfcov19-dataelement-364
Id nfdhtfcov19-dataelement-364 (2025‑02‑03 14:09:36)
Description participantInformation
folder rejected population
nfdhtfcov19-dataelement-366
Id nfdhtfcov19-dataelement-366 (2025‑02‑03 14:27:42)
Concept inherits from final nfdhtfcov19-dataelement-139 (2024‑12‑06 11:28:40)
Description

Population of the [RESOURCE]

Properties

Design.population

Design.population

Relationship
Rationale

Group of items providing information about the population of the [RESOURCE].

Source

NFDI4Health

Comment

Cardinality: 1..1

rejected coverage
nfdhtfcov19-dataelement-367
Id nfdhtfcov19-dataelement-367 (2025‑02‑03 14:28:48)
Concept inherits from final nfdhtfcov19-dataelement-140 (2024‑12‑06 11:28:40)
Description

Coverage

Properties

Design.population.coverage

Design.population.coverage

Relationship
Rationale

Specification of the recruitment area of the [RESOURCE].

Source

NFDI4Health

Comment

Cardinality: 0..1

Operationalization

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)
rejected countries
nfdhtfcov19-dataelement-368
Id nfdhtfcov19-dataelement-368 (2025‑02‑03 14:28:48)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Countries

Properties

Design.population.countries

Design.population.countries

Relationship
Rationale

Country or countries where the [RESOURCE] takes place.

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 1..*

Operationalization

Select all that apply.

Value Domain Code
Choice list
Concept List
Concept Description
Country names from the ISO 3166-1 list

Value Set required http://hl7.org/fhir/ValueSet/country (version 2023‑08‑28 23:09:48)
rejected region
nfdhtfcov19-dataelement-369
Id nfdhtfcov19-dataelement-369 (2025‑02‑03 14:28:48)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Regions and/or cities

Properties

Design.population.region

Design.population.region

Relationship
Rationale

If applicable, regions and/or cities within a country where the [RESOURCE] takes place.

Source NFDI4Health
Comment

Cardinality: 0..1

Value Domain String
rejected description
nfdhtfcov19-dataelement-370
Id nfdhtfcov19-dataelement-370 (2025‑02‑03 14:28:48)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Population description

Properties

Design.population.description

Design.population.description

Relationship
Rationale

Additional descriptive information providing more details about the population of the [RESOURCE].

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

Maelstrom [doi: 10.1371/journal.pone.0200926]

Comment

Cardinality: 0..1

Operationalization

Any information important for the given population can be specified here.

Value Domain String
rejected targetSampleSize
nfdhtfcov19-dataelement-371
Id nfdhtfcov19-dataelement-371 (2025‑02‑03 14:28:48)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Target sample size

Properties

Design.population.targetSampleSize

Design.population.targetSampleSize

Relationship
Rationale

Intended number of observational units for the whole [RESOURCE] (for example intended number of participants at all sites).

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Cardinality: 0..1, if Resource.classification.type == ('Study' OR 'Substudy'); otherwise 0..0

Comment

Cardinality: 0..1, if Resource.classification.type == ('C63536' OR 'C198230'); otherwise 0..0

Comment

Data type in Excel version: integer

Value Domain Quantity
rejected obtainedSampleSize
nfdhtfcov19-dataelement-372
Id nfdhtfcov19-dataelement-372 (2025‑02‑03 14:28:48)
Concept inherits from final  (2024‑12‑06 11:28:40)
Description

Obtained sample size

Properties

Design.population.obtainedSampleSize

Design.population.obtainedSampleSize

Relationship
Rationale

Obtained number of observational units for the whole [RESOURCE] (for example obtained number of participants at all sites).

Source

CT.gov [ https://prsinfo.clinicaltrials.gov/definitions.html], [ https://www.clinicaltrials.gov/ct2/about-studies/glossary]

DRKS [ https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields]

Comment

Additional information: The value is only available after the end of recruitment.

Comment

Cardinality: 0..1

Comment

Data type in Excel version: integer

Value Domain Quantity
cancelled population
nfdhtfcov19-dataelement-365
Id nfdhtfcov19-dataelement-365 (2025‑02‑03 14:21:56)
Description agewMin
Value Domain String
rejected modalities
nfdhtfcov19-dataelement-390
Id nfdhtfcov19-dataelement-390 (2025‑03‑25 11:16:54)
Description modalities
Value Domain Code
cancelled modalities
nfdhtfcov19-dataelement-357
Id nfdhtfcov19-dataelement-357 (2025‑01‑31 13:58:00)
Description Concept
Value Domain String
cancelled bodyPartsExamined
nfdhtfcov19-dataelement-358
Id nfdhtfcov19-dataelement-358 (2025‑02‑03 13:14:31)
Description bodyPartsExamined
Value Domain String