Data Set Module Radiomics (3.4) 2.16.840.1.113883.3.1937.777.64.1.10

Id	nfdhtfcov19-dataelement-359 (2025‑02‑03 13:17:30)
Description	Radiomics

modalities

nfdhtfcov19-dataelement-387

Id	nfdhtfcov19-dataelement-387 (2025‑02‑07 16:09:43)
Description	modalities

acquisition

nfdhtfcov19-dataelement-388

Id	nfdhtfcov19-dataelement-388 (2025‑02‑07 16:10:26)
Description	acquisition
Value Domain	Code

nonAcquisition

nfdhtfcov19-dataelement-389

Id	nfdhtfcov19-dataelement-389 (2025‑02‑07 16:11:15)
Description	nonAcquisition
Value Domain	Code

imagingModalities

nfdhtfcov19-dataelement-360

Id	nfdhtfcov19-dataelement-360 (2025‑02‑03 13:19:02)
Description	modalities
Value Domain	Code

bodyPartsExamined

nfdhtfcov19-dataelement-361

nfdhtfcov19-dataelement-361 (2025‑02‑03 13:35:15)

Description

bodyPartsExamined

Value Domain

Choice list

Concept List
Concept	Description
WHOLEBODY

groupsOfDiseases

nfdhtfcov19-dataelement-383

nfdhtfcov19-dataelement-383 (2025‑02‑03 14:33:18)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Groups of diseases or conditions

Properties

Design.groupsOfDiseases

Relationship

Specialization groupsOfDiseases ( - 2023‑12‑04)

Specialization studyGroupsOfDiseases ( - 2022‑11‑28)

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

generally

nfdhtfcov19-dataelement-384

nfdhtfcov19-dataelement-384 (2025‑02‑03 14:33:45)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

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

Properties

Design.groupsOfDiseases.generally

Relationship

Specialization generally ( - 2023‑12‑04)

Specialization generally ( - 2022‑11‑28)

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..*

Value Domain

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-385

nfdhtfcov19-dataelement-385 (2025‑02‑03 14:33:45)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

On which diseases or conditions were the data collected?

Properties

Design.groupsOfDiseases.conditions

Relationship

Specialization conditions ( - 2023‑12‑04)

Specialization conditions ( - 2022‑11‑28)

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..*

Value Domain

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

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)

centers

nfdhtfcov19-dataelement-386

nfdhtfcov19-dataelement-386 (2025‑02‑03 14:35:01)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Mono- or multicentric?

Properties

Design.centers

Relationship

Specialization centers ( - 2023‑12‑04)

Specialization centers ( - 2022‑11‑28)

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]

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

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)

groupsOfDiseases

nfdhtfcov19-dataelement-362

Id	nfdhtfcov19-dataelement-362 (2025‑02‑03 13:55:22)
Description	diseases
Value Domain	Code

centers

nfdhtfcov19-dataelement-363

Id	nfdhtfcov19-dataelement-363 (2025‑02‑03 14:07:32)
Description	centers
Value Domain	String

eligibilityCriteria

nfdhtfcov19-dataelement-373

nfdhtfcov19-dataelement-373 (2025‑02‑03 14:30:32)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Eligibility criteria

Properties

Design.eligibilityCriteria

Relationship

Specialization eligibilityCriteria ( - 2023‑12‑04)

Specialization eligibilityCriteria ( - 2022‑11‑28)

Rationale

Group of items providing information about eligibility criteria for participants.

Source

NFDI4Health

Comment

Cardinality: 0..1

ageMin

nfdhtfcov19-dataelement-374

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

nfdhtfcov19-dataelement-374 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Eligibility criteria: Minimum age

Properties

Design.eligibilityCriteria.ageMin

Relationship

Specialization ageMin ( - 2022‑11‑28)

Specialization ageMin ( - 2023‑12‑04)

Rationale

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

Source

NFDI4Health

Comment

Cardinality: 0..1

number

nfdhtfcov19-dataelement-375

nfdhtfcov19-dataelement-375 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Minimum eligible age

Properties

Design.eligibilityCriteria.ageMin.number

Relationship

Specialization number ( - 2022‑11‑28)

Specialization number ( - 2023‑12‑04)

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]

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

Value Domain

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

timeUnit

nfdhtfcov19-dataelement-376

nfdhtfcov19-dataelement-376 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Unit of age

Properties

Design.eligibilityCriteria.ageMin.timeUnit

Relationship

Specialization timeUnit ( - 2022‑11‑28)

Specialization timeUnit ( - 2023‑12‑04)

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]

Comment

Cardinality: 1..1

Value Domain

Choice list

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

Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (version 2024‑01‑05 14:59:31)

ageMax

nfdhtfcov19-dataelement-377

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

nfdhtfcov19-dataelement-377 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Eligibility criteria: Maximum age

Properties

Design.eligibilityCriteria.ageMax

Relationship

Specialization ageMax ( - 2022‑11‑28)

Specialization ageMax ( - 2023‑12‑04)

Rationale

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

Source

NFDI4Health

Comment

Cardinality: 0..1

number

nfdhtfcov19-dataelement-378

nfdhtfcov19-dataelement-378 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Maximum eligible age

Properties

Design.eligibilityCriteria.ageMax.number

Relationship

Specialization number ( - 2022‑11‑28)

Rationale

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

Source

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

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

Value Domain

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

timeUnit

nfdhtfcov19-dataelement-379

nfdhtfcov19-dataelement-379 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Unit of age

Properties

Design.eligibilityCriteria.ageMax.timeUnit

Relationship

Specialization timeUnit ( - 2022‑11‑28)

Rationale

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

Source

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

Comment

Cardinality: 1..1

Value Domain

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

Choice list

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

Value Set required NFDI4Health_VS_MDS_Time_Units_UCUM_LOINC (version 2024‑01‑05 14:59:31)

genders

nfdhtfcov19-dataelement-380

nfdhtfcov19-dataelement-380 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Eligible gender

Properties

Design.eligibilityCriteria.genders

Relationship

Specialization genders ( - 2023‑12‑04)

Specialization genders ( - 2022‑11‑28)

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]

Comment

Cardinality: 0..*

Value Domain

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

Choice list

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

Value Set NFDI4Health_VS_MDS_Study_Eligibility_Gender_SNOMEDCT_Local (version 2023‑08‑29 14:35:27)

inclusionCriteria

nfdhtfcov19-dataelement-381

nfdhtfcov19-dataelement-381 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Inclusion criteria

Properties

Design.eligibilityCriteria.inclusionCriteria

Relationship

Specialization inclusionCriteria ( - 2023‑12‑04)

Specialization inclusionCriteria ( - 2022‑11‑28)

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]

Comment

Cardinality: 0..1

Value Domain

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

Example

- First inclusion criterion; - Second inclusion criterion;

exclusionCriteria

nfdhtfcov19-dataelement-382

nfdhtfcov19-dataelement-382 (2025‑02‑03 14:31:44)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Exclusion criteria

Properties

Design.eligibilityCriteria.exclusionCriteria

Relationship

Specialization exclusionCriteria ( - 2023‑12‑04)

Specialization exclusionCriteria ( - 2022‑11‑28)

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]

Comment

Cardinality: 0..1

Value Domain

Example

- First inclusion criterion; - Second inclusion criterion;

eligibilityCriteria

nfdhtfcov19-dataelement-364

Id	nfdhtfcov19-dataelement-364 (2025‑02‑03 14:09:36)
Description	participantInformation

population

nfdhtfcov19-dataelement-366

nfdhtfcov19-dataelement-366 (2025‑02‑03 14:27:42)

Concept inherits from

nfdhtfcov19-dataelement-139 (2024‑12‑06 11:28:40)

Description

Population of the [RESOURCE]

Properties

Design.population

Relationship

Specialization population (nfdhtfcov19-dataelement-139 - 2023‑12‑05 15:32:13)

Rationale

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

Source

NFDI4Health

Comment

Cardinality: 1..1

coverage

nfdhtfcov19-dataelement-367

nfdhtfcov19-dataelement-367 (2025‑02‑03 14:28:48)

Concept inherits from

nfdhtfcov19-dataelement-140 (2024‑12‑06 11:28:40)

Description

Coverage

Properties

Design.population.coverage

Relationship

Specialization coverage (nfdhtfcov19-dataelement-140 - 2023‑12‑05 15:34:17)

Rationale

Specification of the recruitment area of the [RESOURCE].

Source

NFDI4Health

Comment

Cardinality: 0..1

Value Domain

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

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-368

nfdhtfcov19-dataelement-368 (2025‑02‑03 14:28:48)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Countries

Properties

Design.population.countries

Relationship

Specialization countries ( - 2023‑12‑04)

Specialization countries ( - 2022‑11‑28)

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]

Comment

Cardinality: 1..*

Value Domain

Choice list

Concept List
Concept	Description
Country names from the ISO 3166-1 list

Value Set required http://hl7.org/fhir/ValueSet/country (version 2023‑08‑28 23:09:48)

region

nfdhtfcov19-dataelement-369

nfdhtfcov19-dataelement-369 (2025‑02‑03 14:28:48)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Regions and/or cities

Properties

Design.population.region

Relationship

Specialization region ( - 2023‑12‑04)

Specialization region ( - 2022‑11‑28)

Rationale

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

Source

NFDI4Health

Comment

Cardinality: 0..1

Value Domain

description

nfdhtfcov19-dataelement-370

nfdhtfcov19-dataelement-370 (2025‑02‑03 14:28:48)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Population description

Properties

Design.population.description

Relationship

Specialization description ( - 2023‑12‑04)

Specialization population ( - 2022‑11‑28)

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

Value Domain

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

targetSampleSize

nfdhtfcov19-dataelement-371

nfdhtfcov19-dataelement-371 (2025‑02‑03 14:28:48)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Target sample size

Properties

Design.population.targetSampleSize

Relationship

Specialization targetSampleSize ( - 2023‑12‑04)

Specialization targetSampleSize ( - 2022‑11‑28)

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]

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

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

obtainedSampleSize

nfdhtfcov19-dataelement-372

nfdhtfcov19-dataelement-372 (2025‑02‑03 14:28:48)

Concept inherits from

(2024‑12‑06 11:28:40)

Description

Obtained sample size

Properties

Design.population.obtainedSampleSize

Relationship

Specialization obtainedSampleSize ( - 2022‑11‑28)

Specialization obtainedSampleSize ( - 2023‑12‑04)

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]

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