| Name |
Details [‑] |
|
resource
nfdhtfcov19-dataelement-1
|
|
|
| Id |
nfdhtfcov19-dataelement-1 (2020‑01‑15)
|
| Description |
Resource is any object to be published on the study hub. This can be a study, a sub-study,
a study document, a data collection instrument or some other resource types.
|
|
|
resource_classification
nfdhtfcov19-dataelement-23
|
|
|
|
|
resource_type
nfdhtfcov19-dataelement-1.1
|
|
|
| Id |
nfdhtfcov19-dataelement-1.1 (2020‑01‑15)
|
| Synonym |
resource_type
|
| Description |
A term describing the resource.
Select one value from the drop-down list.
The selected value will form a pair with the property “Resource Type (General)”. For
example, the “Resource Type” of “Questionnaire” paired with the “Resource Type (General)”
of “Text” yields
“Text/ Questionnaire”.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Study |
|
code "C0947630" (Scientific Study (Research Activity)) from code system "Unified Medical Language System"
|
| Substudy/Data Collection Event |
|
code "C0010995" (Data Collection (Research Activity)) from code system "Unified Medical Language System"
code "386409003" (Research data collection (procedure)) from code system "SNOMED Clinical Terms"
|
| Dataset |
|
code "C0150098" (Data Set (Intellectual Product)) from code system "Unified Medical Language System"
|
| Study Protocol |
|
code "35528-9" (Clinical trial protocol Clinical trial protocol) from code system "LOINC"
code "C2985594" (Study Protocol Document (Intellectual Product)) from code system "Unified Medical Language System"
code "258049002" (Protocols (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Protocol Amendment |
|
code "C4321383" (Protocol Amendment (Intellectual Product)) from code system "Unified Medical Language System"
|
| Data Dictionary |
|
|
| Informed Consent Form |
|
code "59284-0" (Consent Document) from code system "LOINC"
code "C0009797" (Consent Forms (Intellectual Product)) from code system "Unified Medical Language System"
code "371537001" (Consent report (record artifact)) from code system "SNOMED Clinical Terms"
|
| Patient Information Sheet |
|
code "55188-7" (Patient data Document) from code system "LOINC"
code "C5552264" (Resource information for patient (Intellectual Product)) from code system "Unified Medical Language System"
|
| Manual of Operations (SOPs) |
|
code "89749-6" (Standard operating procedures inventory [CDC Emergency Operations Centers]) from
code system "LOINC"
code "C3889288" (Standard Operating Procedure List (Intellectual Product)) from code system "Unified Medical Language System"
|
| Statistical Analysis Plan |
|
code "C3889277" (Statistical Analysis Plan (Intellectual Product)) from code system "Unified Medical Language System"
|
| Data Management Plan |
|
code "C3899449" (Data Management Plan (Intellectual Product)) from code system "Unified Medical Language System"
|
| Case Report Form |
|
code "75218-8" (Case report) from code system "LOINC"
code "C1516308" (Case Report Form (Intellectual Product)) from code system "Unified Medical Language System"
code "229059009" (Report (record artifact)) from code system "SNOMED Clinical Terms"
|
| Code Book |
|
|
| Questionnaire |
|
code "C0034394" (Questionnaires (Intellectual Product)) from code system "Unified Medical Language System"
|
| Interview Scheme and Themes |
|
|
| Observation Guide |
|
|
| Discussion Guide |
|
code "223482009" (Discussion (procedure)) from code system "SNOMED Clinical Terms"
|
| Participant Tasks |
|
|
| Other Data Collection Instrument |
|
|
| Other Study Document |
|
code "C020539" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Other |
|
|
|
| Value Set NFDI4Health_VS_MDS_Resource_Type_UMLS_Local (version DYNAMIC)
|
|
| Value Set resource_type_SCT (version DYNAMIC)
|
|
| Value Set resource_type_LOINC (version DYNAMIC)
|
|
|
|
resource_type
nfdhtfcov19-dataelement-91
|
|
|
|
|
resource_type_general
nfdhtfcov19-dataelement-1.2
|
|
|
| Id |
nfdhtfcov19-dataelement-1.2 (2020‑01‑15)
|
| Synonym |
resource_type_general
|
| Description |
A more general term describing the resource.
Examples:
1) If “Resource Type” is a “Study”, use “Other” for this property.
2) If “Resource Type” is an “Other study document”, use “Text” for this property.
|
| Operationalization |
Select one value from the
Controlled List.
Text Workflow Other
Example:
If a resource (i.e., resource_type) is a “Study”, use “Other” for this property.
If a resource (i.e., resource_type) is an “Other Study Document”, use “Text” for this
property.
If you are not sure which type to use, select “Other”.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Audiovisual |
|
code "C0681501" (audiovisual document (Intellectual Product)) from code system "Unified Medical Language System"
code "705377002" (Audiovisual device (physical object) ) from code system "SNOMED Clinical Terms"
code "314869000" (Audio and visual equipment (physical object)) from code system "SNOMED Clinical Terms"
|
| Book |
|
code "C0006002" (Books (Intellectual Product)) from code system "Unified Medical Language System"
code "278212002" (Book (physical object) from code system "SNOMED Clinical Terms"
|
| Book chapter |
|
code "C0005990" (Book Chapter (Intellectual Product)) from code system "Unified Medical Language System"
|
| Collection |
|
code "C1704814" (Item Collection (Idea or Concept)) from code system "Unified Medical Language System"
|
| Computational notebook |
|
|
| Conference paper |
|
code "C0814814" (Conference Paper (Intellectual Product)) from code system "Unified Medical Language System"
code "371539003" ( Conference report (record artifact)) from code system "SNOMED Clinical Terms"
|
| Conference proceeding |
|
code "C0009664" (Conference Proceedings as Topic (Intellectual Product)) from code system "Unified Medical Language System"
|
| Data paper |
|
|
| Dataset |
|
code "C0150098" (Data Set (Intellectual Product)) from code system "Unified Medical Language System"
|
| Dissertation |
|
code "C0376645" (Academic Dissertation (Intellectual Product)) from code system "Unified Medical Language System"
|
| Event |
|
code "C0441471" (Event (Event)) from code system "Unified Medical Language System"
code "272379006" (Event (event)) from code system "SNOMED Clinical Terms"
|
| Image |
|
code "C1704922" (Image (Intellectual Product)) from code system "Unified Medical Language System"
code "900000000000520007" (Image (foundation metadata concept)) from code system "SNOMED Clinical Terms"
|
| Interactive resource |
|
|
| Journal |
|
code "C0162443" (Journal (Manufactured Object ; Intellectual Product)) from code system "Unified Medical Language System"
|
| Journal article |
|
code "C0282420" (Journal Article (Intellectual Product)) from code system "Unified Medical Language System"
|
| Model |
|
code "C3161035" (Models (Intellectual Product)) from code system "Unified Medical Language System"
|
| Output management plan |
|
|
| Peer review |
|
code "C0030768" (Peer Review) from code system "Unified Medical Language System"
code "386387004" (Peer review (procedure)) from code system "SNOMED Clinical Terms"
|
| Physical object |
|
code "C0347997" (Physical object) from code system "Unified Medical Language System"
code "260787004" (Physical object (physical object)) from code system "SNOMED Clinical Terms"
|
| Preprint |
|
code "C4704708" (Preprint) from code system "Unified Medical Language System"
|
| Report |
|
code "C0684224" (Report (document)) from code system "Unified Medical Language System"
code "229059009" (Report (record artifact)) from code system "SNOMED Clinical Terms"
|
| Service |
|
code "C0557854" (Services) from code system "Unified Medical Language System"
code "224930009" (Services (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Software |
|
code "C0037585" (Computer software (Manufactured Object ; Intellectual Product)) from code system
"Unified Medical Language System"
code "706687001" (Software (physical object)) from code system "SNOMED Clinical Terms"
|
| Sound |
|
code "C0037709" (Sound - physical agent (Natural Phenomenon or Process)) from code system "Unified Medical Language System"
code "68325009" (Sound, device (physical object)) from code system "SNOMED Clinical Terms"
|
| Standard |
|
code "C2828392" (Standard (document)) from code system "Unified Medical Language System"
|
| Text |
|
code "C1527021" (Text (Intellectual Product)) from code system "Unified Medical Language System"
code "900000000000466004" (Text (foundation metadata concept)) from code system "SNOMED Clinical Terms"
|
| Workflow |
|
code "C1710679" (Workflow (Conceptual Entity)) from code system "Unified Medical Language System"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set ID_resource_type_general_SCT (version DYNAMIC)
|
|
| Value Set ID_resource_type_general_UMLS (version DYNAMIC)
|
|
|
|
resource_titles
nfdhtfcov19-dataelement-2
|
|
|
|
|
language
nfdhtfcov19-dataelement-1.3
|
|
|
| Id |
nfdhtfcov19-dataelement-1.3 (2020‑01‑15)
|
| Synonym |
title_language
|
| Description |
Language of the title.
Please only provide titles that match one of the languages in the drop-down list.
|
| Operationalization |
Select one value from the
Controlled List.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| English |
|
code "C0376245" (English Language) from code system "Unified Medical Language System"
code "297487008" (EN (English)) from code system "SNOMED Clinical Terms"
|
| German |
|
code "C0017477" (German language) from code system "Unified Medical Language System"
code "297490002" (DE (German)) from code system "SNOMED Clinical Terms"
|
| Spanish |
|
code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
code "297510001" (ES (Spanish)) from code system "SNOMED Clinical Terms"
|
| French |
|
code "C0376246" (French language) from code system "Unified Medical Language System"
code "297499001" (FR (French)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other) from code system "SNOMED Clinical Terms"
|
|
| Value Set NFDI4Health_VS_MDS_Language_UMLS (version DYNAMIC)
|
|
| Value Set resource_language_SCT (version DYNAMIC)
|
|
|
|
resource_acronym
nfdhtfcov19-dataelement-3
|
|
|
|
|
language
nfdhtfcov19-dataelement-3.1
|
|
|
| Id |
nfdhtfcov19-dataelement-3.1 (2020‑01‑15)
|
| Description |
Language of the acronym.
Please only provide acronyms that match one of the languages in the drop-down list.
|
| Operationalization |
Only use an acronym that is officially used for the resource. Otherwise, leave this
property empty.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| English |
|
code "C0376245" (English Language) from code system "Unified Medical Language System"
code "297487008" (EN (English)) from code system "SNOMED Clinical Terms"
|
| German |
|
code "C0017477" (German language) from code system "Unified Medical Language System"
code "297490002" (DE (German)) from code system "SNOMED Clinical Terms"
|
| Spanish |
|
code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
code "297510001" (ES (Spanish)) from code system "SNOMED Clinical Terms"
|
| French |
|
code "C0376246" (French language) from code system "Unified Medical Language System"
code "297499001" (FR (French)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other) from code system "SNOMED Clinical Terms"
|
|
| Value Set resource_language_SCT (version DYNAMIC)
|
|
| Value Set NFDI4Health_VS_MDS_Language_UMLS (version DYNAMIC)
|
|
|
|
resource_description_english
nfdhtfcov19-dataelement-18
|
|
|
| Id |
nfdhtfcov19-dataelement-18 (2022‑06‑30 17:38:35)
|
| Description |
A short plain text summary describing the resource in English.
The provided information should be understandable by a scientific audience.
|
|
|
language
nfdhtfcov19-dataelement-17
|
|
|
| Id |
nfdhtfcov19-dataelement-17 (2022‑06‑30 16:54:46)
|
| Rationale |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| EN (English) |
|
code "C0376245" (English Language) from code system "Unified Medical Language System"
code "297487008" (EN (English)) from code system "SNOMED Clinical Terms"
|
|
| Value Set resource_language_SCT (version DYNAMIC)
|
|
| Value Set NFDI4Health_VS_MDS_Language_UMLS (version DYNAMIC)
|
|
|
|
resource_description_non_english
nfdhtfcov19-dataelement-16
|
|
|
|
|
language
nfdhtfcov19-dataelement-99
|
|
|
| Id |
nfdhtfcov19-dataelement-99 (2022‑11‑21 17:04:26)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| DE (German) |
|
code "C0017477" (German language) from code system "Unified Medical Language System"
code "297490002" (DE (German)) from code system "SNOMED Clinical Terms"
|
| ES (Spanish) |
|
code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
code "297510001" (ES (Spanish)) from code system "SNOMED Clinical Terms"
|
| FR (French) |
|
code "C0376246" (French language) from code system "Unified Medical Language System"
code "297499001" (FR (French)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "74964007" (Other) from code system "SNOMED Clinical Terms"
|
|
| Value Set resource_language_SCT (version DYNAMIC)
|
|
| Value Set NFDI4Health_VS_MDS_Language_UMLS (version DYNAMIC)
|
|
|
|
resource_description
nfdhtfcov19-dataelement-4
|
|
|
|
|
description_language
nfdhtfcov19-dataelement-4.2
|
|
|
| Id |
nfdhtfcov19-dataelement-4.2 (2020‑01‑15)
|
| Synonym |
description_language
|
| Description |
The language of the description text.
The description must be provided in English. If the original description of the resource
is non-English, please provide both descriptions: an original description and its
English translation.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| English |
|
code "C0376245" (English Language) from code system "Unified Medical Language System"
code "297487008" (EN (English)) from code system "SNOMED Clinical Terms"
|
| German |
|
code "C0017477" (German language) from code system "Unified Medical Language System"
code "297490002" (DE (German)) from code system "SNOMED Clinical Terms"
|
| Spanish |
|
code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
code "297510001" (ES (Spanish)) from code system "SNOMED Clinical Terms"
|
| French |
|
code "C0376246" (French language) from code system "Unified Medical Language System"
code "297499001" (FR (French)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other) from code system "SNOMED Clinical Terms"
|
|
| Value Set resource_language_SCT (version DYNAMIC)
|
|
| Value Set NFDI4Health_VS_MDS_Language_UMLS (version DYNAMIC)
|
|
|
|
resource_language
nfdhtfcov19-dataelement-1.5
|
|
|
| Id |
nfdhtfcov19-dataelement-1.5 (2020‑01‑15)
|
| Synonym |
resource_language
|
| Description |
Language of the resource, i.e., the language in which a study is conducted, or the
language in which a study document is composed. Please select all languages that apply.
|
| Operationalization |
Select one value from the
Controlled List.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| English |
|
code "C0376245" (English Language) from code system "Unified Medical Language System"
code "297487008" (EN (English)) from code system "SNOMED Clinical Terms"
|
| German |
|
code "C0017477" (German language) from code system "Unified Medical Language System"
code "297490002" (DE (German)) from code system "SNOMED Clinical Terms"
|
| Spanish |
|
code "C0037750" (Spanish Language) from code system "Unified Medical Language System"
code "297510001" (ES (Spanish)) from code system "SNOMED Clinical Terms"
|
| French |
|
code "C0376246" (French language) from code system "Unified Medical Language System"
code "297499001" (FR (French)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other) from code system "SNOMED Clinical Terms"
|
|
| Value Set NFDI4Health_VS_MDS_Language_UMLS (version DYNAMIC)
|
|
| Value Set resource_language_SCT (version DYNAMIC)
|
|
|
|
resource_use_rights
nfdhtfcov19-dataelement-100
|
|
|
|
|
resource_use_rights_label
nfdhtfcov19-dataelement-1.4
|
|
|
| Id |
nfdhtfcov19-dataelement-1.4 (2020‑01‑15)
|
| Synonym |
resource_use_rights_label
|
| Description |
License defining the rights to re-use the resource.
For studies and sub-studies, the selected value is always “Not applicable”, as they
are represented by a simple set of metadata which is not protected by the copyright
law (German: “Urheberrechtsgesetz”).
If “Other” is selected, an explanation of the re-use terms and conditions must be
provided in the property “Resource Use Rights Descriprion”.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| CC0 1.0 (Creative Commons Zero v1.0 Universal) |
|
code "C0009993" (Copyright (Intellectual Product) ) from code system "Unified Medical Language System"
code "C0023636" (License (Regulation or Law) ) from code system "Unified Medical Language System"
|
| CC BY 4.0 (Creative Commons Attribution 4.0 International) |
|
|
| CC BY-NC 4.0 (Creative Commons Attribution Non Commercial 4.0 International) |
|
|
| CC BY-SA 4.0 (Creative Commons Attribution Share Alike 4.0 International) |
|
|
| CC BY-NC-SA 4.0 (Creative Commons Attribution Non Commercial Share Alike 4.0 International) |
|
|
| All rights reserved |
|
|
| N/A |
“N/A” can be selected if a license is not applicable (e.g., for metadata of a resource).
|
code "C1272460" (Not Applicable (Qualitative Concept) ) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Other |
“Other” can be selected in case if another license type is assigned or if it is unknown.
|
code "C1556044" (Other - No Information (Idea or Concept) ) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set time_UMLS (version DYNAMIC)
|
|
| Value Set resource_use_rights_label_UMLS (version DYNAMIC)
|
|
| Value Set resource_use_rights_label_SCT (version DYNAMIC)
|
|
| Value Set Other_and_not_applicable (version DYNAMIC)
|
|
|
|
roles
nfdhtfcov19-dataelement-6
|
|
|
| Id |
nfdhtfcov19-dataelement-6 (2020‑01‑15)
|
| Description |
Function performed by the responsible party, including description of the institution(s)
or person(s) contributing to the development of the resource.
|
|
|
role_name_personal
nfdhtfcov19-dataelement-10
|
|
|
|
|
type
nfdhtfcov19-dataelement-6.1
|
|
|
| Id |
nfdhtfcov19-dataelement-6.1 (2020‑01‑15)
|
| Synonym |
role_type
|
| Description |
Type or role of the resource contributor.
Contributor is a person, a group of persons or an institution contributing to the
development of the resource.
For each resource, there may be multiple contributors, but at least one contributor
must be
specified.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Contact person |
|
code "C0337611" (contact person (Population Group)) from code system "Unified Medical Language System"
code "70862002" (Contact person (person)) from code system "SNOMED Clinical Terms"
|
| Principal investigator |
|
code "C1521895" (Principal Investigator (Professional or Occupational Group)) from code system "Unified Medical Language System"
code "768818001" (Principal investigator (occupation)) from code system "SNOMED Clinical Terms"
|
| Creator/Author |
|
code "C3889686" (Content Item Creator (Qualitative Concept)) from code system "Unified Medical Language System"
code "C3812881" (Author (Professional or Occupational Group)) from code system "Unified Medical Language System"
code "C3853534" (author (originator) (Functional Concept)) from code system "Unified Medical Language System"
|
| Sponsor (primary) |
|
code "C2347675" (Primary Clinical Study Sponsor (Organization)) from code system "Unified Medical Language System"
|
| Sponsor (secondary) |
|
code "C4684768" (Secondary Sponsor (Population Group)) from code system "Unified Medical Language System"
|
| Sponsor-Investigator |
|
code "C4684779" (Sponsor-Investigator (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Data collector |
|
code "C5239262" (Data Contributor ID (Intellectual Product)) from code system "Unified Medical Language System"
|
| Data curator |
|
code "C2348017" (Curator (Occupation or Discipline)) from code system "Unified Medical Language System"
|
| Data manager |
|
code "C1707636" (Data Manager (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Editor |
|
code "C1707883" (Editor (Occupation or Discipline)) from code system "Unified Medical Language System"
|
| Producer |
|
code "C1709696" (Producer (Population Group)) from code system "Unified Medical Language System"
|
| Project leader |
|
|
| Project manager |
|
|
| Project member |
|
|
| Related person |
|
|
| Researcher |
|
code "C0035173" (Research Personnel (Professional or Occupational Group)) from code system "Unified Medical Language System"
code "769038007" (Researcher (occupation)) from code system "SNOMED Clinical Terms"
|
| Rights holder |
|
|
| Supervisor |
|
code "C0403172" (Supervisor (occupation) (Professional of Occupational Group)) from code system
"Unified Medical Language System"
code "236321002" (Supervisor (occupation)) from code system "SNOMED Clinical Terms"
|
| Work package leader |
|
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set role_type_UMLS (version DYNAMIC)
|
|
| Value Set role_type_SCT (version DYNAMIC)
|
|
|
|
role_name_personal_title
nfdhtfcov19-dataelement-6.3
|
|
|
| Id |
nfdhtfcov19-dataelement-6.3 (2020‑01‑15)
|
| Description |
Title of the person.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Mr. |
|
code "C2347167" (Mr. - Title (Conceptual Entity)) from code system "Unified Medical Language System"
|
| Ms. |
|
code "C2349188" (Mrs - title (Conceptual Entity)) from code system "Unified Medical Language System"
|
| Dr. |
|
code "C2348314" (Doctor - Title (Conceptual Entity)) from code system "SNOMED Clinical Terms"
|
| Prof. Dr. |
|
code "C0599518" (Professor (Professional of Occupational Group)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "SNOMED Clinical Terms"
code "C0205394" (Other (Qualitative Concept)) from code system "SNOMED Clinical Terms"
|
|
| Value Set role_name_personal_title UMLS (version DYNAMIC)
|
|
|
|
role_name_identifiers
nfdhtfcov19-dataelement-11
|
|
|
|
|
scheme
nfdhtfcov19-dataelement-6.4
|
|
|
| Id |
nfdhtfcov19-dataelement-6.4 (2020‑01‑15)
|
| Synonym |
role_name_identifier_scheme
|
| Description |
Type of the name identifier scheme. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| ORCID |
|
code "C5239262" (Data Contributor ID (Intellectual Product)) from code system "Unified Medical Language System"
|
| ROR |
|
|
| GRID |
|
|
| ISNI |
|
|
|
|
|
role_affiliation_identifiers
nfdhtfcov19-dataelement-12
|
|
|
|
|
scheme
nfdhtfcov19-dataelement-6.5
|
|
|
| Id |
nfdhtfcov19-dataelement-6.5 (2020‑01‑15)
|
| Synonym |
role_affiliation_identifier_scheme
|
| Description |
If applicable, phone number associated with the role.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
| ROR |
|
| GRID |
|
| ISNI |
|
|
|
|
role_name_type
nfdhtfcov19-dataelement-19
|
|
|
|
|
role_name_type
nfdhtfcov19-dataelement-6.2
|
|
|
| Id |
nfdhtfcov19-dataelement-6.2 (2020‑01‑15)
|
| Synonym |
role_name_type
|
| Description |
Type of the name of the conributor. Organisational name can be used to denote a research group or institution.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Personal |
|
code "C1519021" (Personal Attribute ) from code system "Unified Medical Language System"
|
| Organisational |
|
code "C0220885" (Organizational (Qualitative Concept)) from code system "Unified Medical Language System"
|
|
| Value Set NFDI4Health_VS_MDS_Role_Name_Type_UMLS (version DYNAMIC)
|
|
|
|
role_name_organisational_group
nfdhtfcov19-dataelement-31
|
|
|
|
|
type
nfdhtfcov19-dataelement-32
|
|
|
| Id |
nfdhtfcov19-dataelement-32 (2022‑07‑09 08:35:18)
|
| Description |
Name of the institution or research group. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Contact |
|
code "C0337611" (contact person (Population Group)) from code system "Unified Medical Language System"
code "70862002" (Contact person (person)) from code system "SNOMED Clinical Terms"
|
| Creator/Author |
|
code "C3853534" (author (originator) (Functional Concept)) from code system "Unified Medical Language System"
code "C3812881" (Author (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Sponsor (primary) |
|
code "C2347675" (Primary Clinical Study Sponsor (Organization)) from code system "Unified Medical Language System"
code "C2985689" (Study Legal Sponsor (Professional or Occupational Group)) from code system "SNOMED Clinical Terms"
|
| Sponsor (secondary) |
|
code "C4684768" (Secondary Sponsor (Population Group)) from code system "Unified Medical Language System"
|
| Sponsor-Investigator |
|
code "C4684779" (Sponsor-Investigator (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Data collector |
|
|
| Data curator |
|
code "C2348017" (Curator (Occupation or Discipline)) from code system "Unified Medical Language System"
|
| Data manager |
|
code "C1707636" (Data Manager (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Distributor |
|
code "C1704728" (Distributor (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Hosting institution |
|
|
| Producer |
|
code "C1709696" (Producer (Population Group)) from code system "Unified Medical Language System"
|
| Publisher |
|
code "C1709767" (Publisher (Occupation or Discipline)) from code system "Unified Medical Language System"
|
| Registration agency |
|
|
| Registration authority |
|
code "C2699022" (Registration Authority (Organization)) from code system "Unified Medical Language System"
|
| Research group |
|
code "C0035173" (Research Personnel (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Rights holder |
|
|
| Supervisor |
|
code "C0403172" (Supervisor (occupation) (Professional of Occupational Group)) from code system
"Unified Medical Language System"
code "236321002" (Supervisor (occupation)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Funder (public) |
|
code "C3640788" (Public Funding (Functional Concept)) from code system "Unified Medical Language System"
code "C3640786" (Private Funding (Functional Concept)) from code system "Unified Medical Language System"
|
| Funder (private) |
|
|
|
| Value Set role_type_UMLS (version DYNAMIC)
|
|
| Value Set role_type_SCT (version DYNAMIC)
|
|
|
|
ids
nfdhtfcov19-dataelement-5
|
|
|
|
|
ids_nfdi4health
nfdhtfcov19-dataelement-39
|
|
|
|
|
relation_type
nfdhtfcov19-dataelement-40
|
|
|
| Id |
nfdhtfcov19-dataelement-40 (2022‑07‑09 09:09:54)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| is continued by, |
|
code "367409002" (Followed by (attribute)) from code system "SNOMED Clinical Terms"
|
| continues, |
|
code "363708005" (Temporally follows (attribute)) from code system "SNOMED Clinical Terms"
|
| is described by, |
|
|
| describes, |
|
|
| has version, |
|
|
| is version of, |
|
|
| is new version of, |
|
|
| is previous version of, |
|
|
| is part of, |
|
code "C1292711" (part of (Spatial Concept)) from code system "Unified Medical Language System"
code "774081006" (Proper part of (attribute)) from code system "SNOMED Clinical Terms"
|
| has part, |
|
code "C1554207" (Role Link Type - has part (Intellectual Product)) from code system "Unified Medical Language System"
code "55919000" (Including (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is variant form of, |
|
|
| is original form of, |
|
code "19535007" (Original (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is identical to, |
|
code "20323000" (Identical (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is reviewed by, |
|
code "54776003" (Controlled by (attribute)) from code system "SNOMED Clinical Terms"
|
| reviews, |
|
|
| is derived from, |
|
code "C1550535" (is derived from (Idea or Concept)) from code system "Unified Medical Language System"
|
| is source of, |
|
|
| is obsoleted by, |
|
code "C1299987" (Replaced by (Functional Concept) ) from code system "Unified Medical Language System"
|
| obsoletes, |
|
code "C1553396" ( replaces - RoleLinkType (Idea or Concept)) from code system "Unified Medical Language System"
code "41228009" (Obsolete (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
|
|
ids_alternative
nfdhtfcov19-dataelement-43
|
|
|
| Id |
nfdhtfcov19-dataelement-43 (2022‑07‑09 09:11:17)
|
| Description |
An identifier (ID) related to, or associated with, the resource. This can be ID(s)
of the related resource(s), or an alternate identifier of the given resource provided
by another registering system.
Examples:
a) A Digital Object Identifier (DOI) of the publication associated with the resource.
The format should be a value
beginning with a “10”, for example, 10.3238/arztebl.2020.0861. The value will be automatically
appended to http://dx.doi.org/.
b) A link (URL) to the webpage where supporting information for the resource can be
found.
c) A DRKS-ID assigned to the study by the German Clinical Trials Register (DRKS).
For example, DRKS00023334.
|
|
|
type
nfdhtfcov19-dataelement-44
|
|
|
| Id |
nfdhtfcov19-dataelement-44 (2022‑07‑09 09:11:48)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| DRKS |
|
|
| UTN |
|
|
| ISRCTN |
|
|
| EudraCT |
|
code "C4329800" (European Union Drug Regulating Authorities Clinical Trials Database (Intellectual
Product)) from code system "Unified Medical Language System"
|
| EUDAMED |
|
|
| NCT (ClinicalTrials.gov) |
|
code "C4287891" (Clinicaltrials.gov NCT Number for the Expanded Access Record (Intellectual Product))
from code system "Unified Medical Language System"
|
| KonsortSWD |
|
|
| MDM Portal |
|
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "C1556044" (Other - No Information (Idea or Concept) ) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set Other_and_not_applicable (version DYNAMIC)
|
|
| Value Set ID_type_UMLS (version DYNAMIC)
|
|
| Value Set ID_type_SCT (version DYNAMIC)
|
|
|
|
ids
nfdhtfcov19-dataelement-42
|
|
|
|
|
type
nfdhtfcov19-dataelement-5.1
|
|
|
| Id |
nfdhtfcov19-dataelement-5.1 (2020‑01‑15)
|
| Synonym |
ID_type
|
| Description |
Type of the ID.
Three main groups of ID types are:
(*) IDs usually applied to documents and publications (e.g., DOI, Handle, URL).
(**) IDs applied to studies registered in clinical trials register(s) (e.g., ISRCTN
or NCT number).
(***) other types of IDs (e.g.,
grant number).
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| arXiv |
|
|
| DOI |
|
code "C2348291" (Digital Object Identifier (Intellectual Product)) from code system "Unified Medical Language System"
|
| EAN13 |
|
|
| EISSN |
|
|
| Handle |
|
code "C1708320" (Handle - program access (Conceptual Entity)) from code system "Unified Medical Language System"
|
| ISBN |
|
|
| ISSN |
|
|
| ISTC |
|
|
| LISSN |
|
|
| LSID |
|
code "C1708696" (Life Sciences Identifier (Conceptual Entity)) from code system "Unified Medical Language System"
|
| PMID |
|
code "C4288349" (PubMed Identifier for Citation Used in Study (Intellectual Product)) from code
system "Unified Medical Language System"
|
| PURL |
|
|
| URL |
|
code "C1710546" (Uniform Resource Locator (Intellectual Product)) from code system "Unified Medical Language System"
code "900000000000469006" (Uniform resource locator (foundation metadata concept)) from code system "SNOMED Clinical Terms"
|
| URN |
|
code "C2349021" (Uniform Resource Name (Intellectual Product)) from code system "Unified Medical Language System"
|
| w3id |
|
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set ID_type_UMLS (version DYNAMIC)
|
|
| Value Set ID_type_SCT (version DYNAMIC)
|
|
|
|
relation_type
nfdhtfcov19-dataelement-5.3
|
|
|
| Id |
nfdhtfcov19-dataelement-5.3 (2020‑01‑15)
|
| Synonym |
relation_type
|
| Description |
Type of the relationship of the resource being registered (A) to the related resource
(B).
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| is cited by, |
|
|
| cites, |
|
|
| is supplement to, |
|
code "C1550540" (is appendage - ActRelationshipType (Intellectual Product)) from code system "Unified Medical Language System"
|
| is supplemented by, |
|
|
| is continued by, |
|
code "367409002" (Followed by (attribute)) from code system "SNOMED Clinical Terms"
|
| continues, |
|
code "363708005" (Temporally follows (attribute)) from code system "SNOMED Clinical Terms"
|
| is described by, |
|
|
| describes, |
|
|
| has metadata, |
|
code "C3242305" (has metadata (Intellectual Product)) from code system "Unified Medical Language System"
|
| is metadata for, |
|
|
| has version, |
|
|
| is version of, |
|
|
| is new version of, |
|
code "C1550541" ( Updates (condition) (Idea or Concept) ) from code system "Unified Medical Language System"
|
| is previous version of, |
|
|
| is part of, |
|
code "C1292711" (part of (Spatial Concept)) from code system "Unified Medical Language System"
code "774081006" (Proper part of (attribute)) from code system "SNOMED Clinical Terms"
|
| has part, |
|
code "C1553886" (Concept Code Relationship - has part (Intellectual Product) ) from code system
"Unified Medical Language System"
code "55919000" (Including (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is referenced by, |
|
|
| references, |
|
code "C1551375" (refers to - ActRelationshipType (Idea or Concept)) from code system "Unified Medical Language System"
code "C3243491" (ActRelationshipRefersTo (Intellectual Product)) from code system "Unified Medical Language System"
|
| is documented by, |
|
code "397934002" (Documented (qualifier value)) from code system "SNOMED Clinical Terms"
|
| documents, |
|
code "C1548385" (Act Relationship Type - documents (Idea of Concept)) from code system "Unified Medical Language System"
code "397966007" (Documents (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is compiled by, |
|
code "C1550519" (has component (Idea or Concept)) from code system "Unified Medical Language System"
|
| compiles, |
|
|
| is variant form of, |
|
|
| is original form of, |
|
code "19535007" (Original (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is identical to, |
|
code "20323000" (Identical (qualifier value)) from code system "SNOMED Clinical Terms"
|
| is reviewed by, |
|
code "54776003" (Controlled by (attribute)) from code system "SNOMED Clinical Terms"
|
| reviews, |
|
code "C1550545" (evaluates (goal) (Intellectual Product) ) from code system "Unified Medical Language System"
|
| is derived from, |
|
code "C1550535" (is derived from (Idea or Concept)) from code system "Unified Medical Language System"
|
| is source of, |
|
|
|
| Value Set ID_relation_type_UMLS (version DYNAMIC)
|
|
| Value Set ID_relation_type_SCT (version DYNAMIC)
|
|
|
|
resource_type_general
nfdhtfcov19-dataelement-5.2
|
|
|
| Id |
nfdhtfcov19-dataelement-5.2 (2020‑01‑15)
|
| Description |
Type of the related resource referenced by the ID. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Audiovisual |
|
code "C0681501" (Audiovisual document (Intellectual Product)) from code system "Unified Medical Language System"
code "705377002" (Audiovisual device (physical object)) from code system "SNOMED Clinical Terms"
code "314869000" (Audio and visual equipment (physical object)) from code system "SNOMED Clinical Terms"
|
| Book |
|
code "C0006002" (Books (Intellectual Product)) from code system "Unified Medical Language System"
code "278212002" (Book (physical object)) from code system "SNOMED Clinical Terms"
|
| Book chapter |
|
code "C0005990" (Book Chapter (Intellectual Product)) from code system "Unified Medical Language System"
|
| Collection |
|
code "C1704814" (Item Collection (Idea or Concept)) from code system "Unified Medical Language System"
|
| Computational notebook |
|
|
| Conference paper |
|
code "C0814814" (Conference Paper (Intellectual Product)) from code system "Unified Medical Language System"
|
| Conference proceeding |
|
code "C0009664" (Conference Proceedings as Topic (Intellectual Product)) from code system "Unified Medical Language System"
|
| Data paper |
|
|
| Dataset |
|
code "C0150098" (Data Set (Intellectual Product)) from code system "Unified Medical Language System"
|
| Dissertation |
|
code "C0376645" (Academic Dissertation (Intellectual Product)) from code system "Unified Medical Language System"
|
| Event |
|
code "C0441471" (Event (Event)) from code system "Unified Medical Language System"
code "272379006" (Event (event)) from code system "SNOMED Clinical Terms"
|
| Image |
|
code "C1704922" (Image (Intellectual Product)) from code system "Unified Medical Language System"
code "900000000000520007" (Image (foundation metadata concept)) from code system "SNOMED Clinical Terms"
|
| Interactive resource |
|
|
| Journal |
|
code "C0162443" (Journal (Manufactured Object ; Intellectual Product)) from code system "Unified Medical Language System"
|
| Journal article |
|
code "C0282420" (Journal Article (Intellectual Product)) from code system "Unified Medical Language System"
|
| Model |
|
code "C3161035" (Models (Intellectual Product)) from code system "Unified Medical Language System"
|
| Output management plan |
|
|
| Peer review |
|
code "C0030768" (Peer Review) from code system "Unified Medical Language System"
code "386387004" (Peer review (procedure)) from code system "SNOMED Clinical Terms"
|
| Physical object |
|
code "C0347997" (Physical object) from code system "Unified Medical Language System"
code "260787004" (Physical object (physical object)) from code system "SNOMED Clinical Terms"
|
| Preprint |
|
code "C4704708" (Preprint ) from code system "Unified Medical Language System"
|
| Report |
|
code "C0684224" (Report (document) ) from code system "Unified Medical Language System"
code "229059009" (Report (record artifact)) from code system "SNOMED Clinical Terms"
|
| Service |
|
code "C0557854" (Services ) from code system "Unified Medical Language System"
code "224930009" (Services (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Software |
|
code "C0037585" (Computer software (Manufactured Object ; Intellectual Product)) from code system
"Unified Medical Language System"
code "706687001" (Software (physical object)) from code system "SNOMED Clinical Terms"
|
| Sound |
|
code "C0037709" (Sound - physical agent (Natural Phenomenon or Process)) from code system "Unified Medical Language System"
code "68325009" (Sound, device (physical object)) from code system "SNOMED Clinical Terms"
|
| Standard |
|
code "C2828392" (Standard (document) ) from code system "Unified Medical Language System"
|
| Text |
|
code "C1527021" (Text (Intellectual Product)) from code system "Unified Medical Language System"
code "900000000000466004" (Text (foundation metadata concept)) from code system "SNOMED Clinical Terms"
|
| Workflow |
|
code "C1710679" (Workflow (Conceptual Entity)) from code system "Unified Medical Language System"
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "C1556044" (Other - No Information (Idea or Concept)) from code system "SNOMED Clinical Terms"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set NFDI4Health_VS_MDS_Resource_Type_General_NCI_UMLS_Local (version DYNAMIC)
|
|
| Value Set resource_type_general_SCT (version DYNAMIC)
|
|
|
|
study_design
nfdhtfcov19-dataelement-7
|
|
|
| Id |
nfdhtfcov19-dataelement-7 (2020‑01‑15)
|
| Synonym |
StudyDesign
|
| Description |
Description of a study or sub-study design. The properties should be filled in only
if a study or sub-study is being registered as a resource. The properties refer to
both interventional and non-interventional studies.
|
|
|
study_arms_groups
nfdhtfcov19-dataelement-2.1
|
|
|
| Id |
nfdhtfcov19-dataelement-2.1 (2020‑01‑15)
|
| Operationalization |
The title must be provided in English. If original title of the resource is non-English,
please provide both titles: an original title and its English translation.
|
|
|
study_arm_group_type
nfdhtfcov19-dataelement-2.2
|
|
|
| Id |
nfdhtfcov19-dataelement-2.2 (2020‑01‑15)
|
| Description |
Role of the given arm in the study. |
| Operationalization |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Experimental |
|
code "C5420675" (Investigational Arm (Research Study)) from code system "Unified Medical Language System"
|
| Active comparator |
|
code "C2347177" (Active Comparator (Conceptual Entity)) from code system "Unified Medical Language System"
|
| Placebo comparator |
|
code "C5420677" (Placebo Control Arm (Research Activity)) from code system "Unified Medical Language System"
|
| Sham comparator |
|
code "C5420678" (Sham Comparator Arm (Research Activity)) from code system "Unified Medical Language System"
code "C4553390" (Comparator (Intellectual Product)) from code system "Unified Medical Language System"
|
| No intervention |
|
code "C5420679" (No Intervention Arm (Research Activity)) from code system "Unified Medical Language System"
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_arm_group_type_UMLS (version DYNAMIC)
|
|
| Value Set Other_and_not_applicable (version DYNAMIC)
|
|
|
|
study_data_sharing_plan
nfdhtfcov19-dataelement-77
|
|
|
|
|
study_data_sharing_plan_generally
nfdhtfcov19-dataelement-7.14
|
|
|
| Id |
nfdhtfcov19-dataelement-7.14 (2020‑01‑15)
|
| Description |
Indication whether there is a plan to make data collected in the study available.
In case of studies with patients or other individuals, this refers to individual participant
data (IPD).
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Yes, there is a plan to make data available. |
|
code "C5399964" (Yes (Finding) unpräzise) from code system "Unified Medical Language System"
code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
|
| No, there is no plan to make data available. |
|
code "C1298908" (no (Finding) unpräzise) from code system "Unified Medical Language System"
code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Undecided, it is not yet known if data will be made available. |
|
code "C4534364" (Undecided (Finding)) from code system "Unified Medical Language System"
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_data_sharing_plan_generally_UMLS (version DYNAMIC)
|
|
| Value Set study_data_sharing_plan_generally_SCT (version DYNAMIC)
|
|
|
|
study_data_sharing_plan_datashield
nfdhtfcov19-dataelement-78
|
|
|
| Id |
nfdhtfcov19-dataelement-78 (2022‑07‑11 12:08:18)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Yes |
|
code "C5399964" (Yes (Finding)) from code system "Unified Medical Language System"
code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
|
| No |
|
code "C1298908" (No (Finding)) from code system "Unified Medical Language System"
code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Pending |
|
code "C1611271" (Pending - Status) from code system "Unified Medical Language System"
|
|
| Value Set 2.16.840.1.113883.3.1937.777.64.11.1 (version DYNAMIC)
|
|
|
|
study_data_sharing_plan_supporting_information
nfdhtfcov19-dataelement-7.15
|
|
|
| Id |
nfdhtfcov19-dataelement-7.15 (2020‑01‑15)
|
| Description |
Supporting information which will be made available in addition to the study data. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Data dictionary |
|
|
| Study protocol |
|
code "258049002" (Protocols (qualifier value)) from code system "SNOMED Clinical Terms"
code "C2348563" (Study Protocol (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Protocol amendment |
|
code "C4321383" (Protocol Amendment (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Statistical analysis plan |
|
code "C3889277" (Statistical Analysis Plan (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Analytic code |
|
|
| Informed consent form |
|
code "371537001" (Consent report (record artifact)) from code system "SNOMED Clinical Terms"
code "C0009797" (Consent Forms (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Clinical study report |
|
code "229059009" (Report (record artifact)) from code system "SNOMED Clinical Terms"
code "C4553084" (Clinical study report (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Manual of operations (SOP) |
|
code "C3889288" (Standard Operating Procedure List (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Case report form (template) |
|
code "C1516308" (Case Report Form (Intellectual Product) ) from code system "SNOMED Clinical Terms"
|
| Questionnaire (template) |
|
code "C0034394" (Questionnaires (Intellectual Product)) from code system "SNOMED Clinical Terms"
|
| Code book |
|
|
| Other |
|
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
code "C1556044" (Other - No Information (Idea or Concept)) from code system "SNOMED Clinical Terms"
code "C0205394" (Other (Qualitative Concept)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_data_sharing_plan_supporting_information_SCT (version DYNAMIC)
|
|
| Value Set study_data_sharing_plan_supporting_information_UMLS (version DYNAMIC)
|
|
|
|
study_masking_general
nfdhtfcov19-dataelement-80
|
|
|
|
|
study_masking_roles
nfdhtfcov19-dataelement-8.3
|
|
|
| Id |
nfdhtfcov19-dataelement-8.3 (2020‑01‑15)
|
| Description |
If masking is implemented, the party(ies) who are masked. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Participant |
|
code "C4554048" (Study Participant (Population Group)) from code system "Unified Medical Language System"
code "428024001" (Clinical trial participant (person)) from code system "SNOMED Clinical Terms"
|
| Care Provider |
|
code "C1704312" (Health Professional (Professional or Occupational Group)) from code system "Unified Medical Language System"
|
| Investigator |
|
code "C0025173" (Research Personnel (Professional or Occupational Group)) from code system "Unified Medical Language System"
code "768815003" (Investigative specialist (occupation)) from code system "SNOMED Clinical Terms"
code "768818001" (Principal investigator (occupation)) from code system "SNOMED Clinical Terms"
|
| Outcomes Assessor |
|
code "C0086749" (Outcome Measures (Quantitative Concept) unpräzise) from code system "Unified Medical Language System"
|
|
| Value Set study_masking_roles_SCT (version DYNAMIC)
|
|
| Value Set study_masking_roles_UMLS (version DYNAMIC)
|
|
|
|
study_conditions
nfdhtfcov19-dataelement-7.16
|
|
|
|
|
study_conditions_classification
nfdhtfcov19-dataelement-7.3
|
|
|
| Id |
nfdhtfcov19-dataelement-7.3 (2020‑01‑15)
|
| Synonym |
study_conditions_classification
|
| Description |
Controlled terminology used for the health condition or disease studied in the study,
or the focus of the study.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| MeSH |
|
code "C1135584" (Medical Subject Headings (Intellectual Product)) from code system "Unified Medical Language System"
|
| ICD-10 |
|
code "C1137110" (International Statistical Classification of Diseases and Related Health Problems,
Tenth Revision (ICD-10) (Intellectual Product)) from code system "Unified Medical Language System"
|
| MedDRA |
|
code "C1140263" (Medical Dictionary for Regulatory Activities Terminology (MedDRA) (Intelectual
Product)) from code system "Unified Medical Language System"
|
| SNOMED CT |
|
code "C1623497" (Systematized Nomenclature of Medicine Clinical Terms (Intellectual Product)) from
code system "Unified Medical Language System"
|
| Other vocabulary |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Free text |
|
code "C2066349" (Free text for notes (Intellectual Product)) from code system "Unified Medical Language System"
code "C2348713" (Free Text Format (Qualitative Concept)) from code system "Unified Medical Language System"
code "900000000000466004" (Text (foundation metadata concept)) from code system "SNOMED Clinical Terms"
code "900000000000465000" (String (foundation metadata concept)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_conditions_classification_SCT (version DYNAMIC)
|
|
| Value Set study_conditions_classification_UMLS (version DYNAMIC)
|
|
|
|
study_outcomes
nfdhtfcov19-dataelement-7.17
|
|
|
|
|
study_outcome_type
nfdhtfcov19-dataelement-7.18
|
|
|
| Id |
nfdhtfcov19-dataelement-7.18 (2020‑01‑15)
|
| Synonym |
study_outcome_type
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Primary |
|
code "C4743557" (Primary Outcome Variable (Intellectual Product)) from code system "Unified Medical Language System"
code "63161005" (Principal (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Secondary |
|
code "C4743558" (Secondary Outcome Variable (Intellectual Product)) from code system "Unified Medical Language System"
code "2603003" (Secondary (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_outcome_type_SCT (version DYNAMIC)
|
|
| Value Set study_outcome_type_UMLS (version DYNAMIC)
|
|
|
|
study_design_interventional
nfdhtfcov19-dataelement-79
|
|
|
|
|
study_off_label_use
nfdhtfcov19-dataelement-7.19
|
|
|
| Id |
nfdhtfcov19-dataelement-7.19 (2020‑01‑15)
|
| Description |
Unapproved (off-label) use of a drug product. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Yes |
|
code "C5399964" (Yes (Finding) ) from code system "Unified Medical Language System"
code "C1705108" (Yes (indicator) (Finding)) from code system "Unified Medical Language System"
code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
|
| No |
|
code "C1298908" (No (Finding)) from code system "Unified Medical Language System"
code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Not applicable |
|
code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_off_label_use_SCT (version DYNAMIC)
|
|
| Value Set study_off_label_use_UMLS (version DYNAMIC)
|
|
|
|
study_allocation
nfdhtfcov19-dataelement-4.1
|
|
|
| Id |
nfdhtfcov19-dataelement-4.1 (2020‑01‑15)
|
| Description |
Type of assignment (allocation) of individual participants to an arm. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Randomized |
|
code "C0206034" (Clinical Trials, Randomized (Research Activity)) from code system "Unified Medical Language System"
code "C0282440" (Randomized Controlled Trials as Topic (Intellectual Product)) from code system
"Unified Medical Language System"
code "1156943004" (Randomized clinical trial (procedure)) from code system "SNOMED Clinical Terms"
|
| Nonrandomized |
|
code "C2985410" (Non-Randomized Controlled Trials as Topic (Research Activity)) from code system
"Unified Medical Language System"
code "C0150104" (Nonrandomized Control Trials (Research Activity)) from code system "Unified Medical Language System"
|
| Not applicable (for single-arm trials) |
|
code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_allocation_SCT (version DYNAMIC)
|
|
| Value Set study_allocation_UMLS (version DYNAMIC)
|
|
|
|
study_phase
nfdhtfcov19-dataelement-8.4
|
|
|
| Id |
nfdhtfcov19-dataelement-8.4 (2020‑01‑15)
|
| Description |
If applicable, numerical phase of the study
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Early-phase-1 |
|
code "C1882358" (Phase 0 Trial (Research Activity)) from code system "Unified Medical Language System"
|
| Phase-1 |
|
code "C0920321" (Phase I Clinical Trials (Research Activity)) from code system "Unified Medical Language System"
code "272109004" (Phase 1 (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Phase-1-phase-2 |
|
code "C1519043" (Phase I/II Trial (Research Activity)) from code system "Unified Medical Language System"
|
| Phase-2 |
|
code "C0282460" (Phase 2 Clinical Trials (Research Activity)) from code system "Unified Medical Language System"
code "272110009" (Phase 2 (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Phase-2a |
|
code "C1706446" (Trial Phase 2A (Research Activity) from code system "Unified Medical Language System"
|
| Phase-2b |
|
code "C1706096" (Phase II B Trial (Research Activity)) from code system "Unified Medical Language System"
|
| Phase-2-phase-3 |
|
code "C1519042" (Phase II/III Trial (Research Activity)) from code system "Unified Medical Language System"
|
| Phase-3 |
|
code "C0282461" (Phase 3 Clinical Trials (Research Activity)) from code system "Unified Medical Language System"
code "272111008" (Phase 3 (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Phase-3a |
|
code "C1706447" (Trial Phase 3A (Research Activity)) from code system "Unified Medical Language System"
|
| Phase-3b |
|
code "C170609" (Trial Phase 3B (Research Activity)) from code system "Unified Medical Language System"
|
| Phase-4 |
|
code "C0282462" (Phase 4 Clinical Trials (Research Activity)) from code system "Unified Medical Language System"
code "255271000" (Phase 4 (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Not applicable |
|
code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_phase_SCT (version DYNAMIC)
|
|
| Value Set study_phase_UMLS (version DYNAMIC)
|
|
|
|
study_design_non_interventional
nfdhtfcov19-dataelement-5.4
|
|
|
|
|
study_time_perspectives
nfdhtfcov19-dataelement-6.6
|
|
|
| Id |
nfdhtfcov19-dataelement-6.6 (2020‑01‑15)
|
| Synonym |
study_time_perspective
|
| Description |
Temporal relationship of observation period to time of participant enrollment.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Retrospective |
|
code "C0035363" (Respective Studies (Research Activity)) from code system "Unified Medical Language System"
|
| Prospective |
|
code "C0033522" (Prospective Studies (Research Activty)) from code system "Unified Medical Language System"
|
| Cross-sectional |
|
code "C0010362" (Cross-Sectional Studies (Research Activity)) from code system "Unified Medical Language System"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_time_perspective_UMLS (version DYNAMIC)
|
|
| Value Set Other_and_not_applicable (version DYNAMIC)
|
|
|
|
study_biospecimen_retention
nfdhtfcov19-dataelement-6.7
|
|
|
| Id |
nfdhtfcov19-dataelement-6.7 (2020‑01‑15)
|
| Description |
Indication whether samples of material from study participants are retained in a biorepository.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| None retained |
|
code "C4289918" (Biospecimens Not Retained (Conceptual Entity)) from code system "Unified Medical Language System"
code "260413007" (None (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Samples with DNA |
|
code "C4288286" (Retained Specimens Contain DNA (Conceptual Entity)) from code system "Unified Medical Language System"
|
| Samples without DNA |
|
code "C4288285" (Retained Specimens Do Not Contain DNA (Conceptual Entity)) from code system "Unified Medical Language System"
|
|
| Value Set study_biospecimen_retention_SCT (version DYNAMIC)
|
|
| Value Set study_biospecimen_retention_UMLS (version DYNAMIC)
|
|
|
|
study_type
nfdhtfcov19-dataelement-8
|
|
|
| Id |
nfdhtfcov19-dataelement-8 (2020‑01‑15)
|
| Description |
Description of an interventional study or sub-study design. The properties should
be filled in only if an interventional study or sub-study is being registered.
|
|
|
study_type_noninterventional
nfdhtfcov19-dataelement-7.2
|
|
|
| Id |
nfdhtfcov19-dataelement-7.2 (2020‑01‑15)
|
| Description |
In case of an interventional study, the strategy for assigning interventions to participants.
In case of a non- interventional (observational) study, the primary strategy for participant
identification and follow-up.
|
| Operationalization |
study_type_noninterventional is a conditional on study_primary_design |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Case-control |
|
code "C0007328" (Case-Control Studies (Research Activity)) from code system "Unified Medical Language System"
|
| Nested Case-control |
|
|
| Case-only |
|
code "C0085973" (Case Study (Intellectual Product)) from code system "Unified Medical Language System"
|
| Case-crossover |
|
code "C4288565" (Observational Case-Crossover Study (Research Activity)) from code system "Unified Medical Language System"
|
| Ecologic or community studies |
|
code "C4289598" (Ecologic or Community Based Study (Research Activity)) from code system "Unified Medical Language System"
|
| Family-based |
|
code "C0199236" (Family Study (Diagnostic Procedure)) from code system "Unified Medical Language System"
|
| Twin study |
|
code "C0282476" (Twin Studies as Topic (Research Activity)) from code system "Unified Medical Language System"
|
| Case Cohort |
|
|
| Cohort |
|
code "C0009247" (Cohort Studies (Quantitative Concept)) from code system "Unified Medical Language System"
|
| Birth cohort |
|
code "C5544491" (Birth Cohort Studies (Research Activity)) from code system "Unified Medical Language System"
|
| Trend |
|
code "C0681702" (Trend Analysis (Functional Concept)) from code system "Unified Medical Language System"
|
| Panel |
|
code "C0681848" (Panel Study (Research Activity)) from code system "Unified Medical Language System"
|
| Longitudinal |
|
code "C0023981" (Longitudinal Studies (Research Activity)) from code system "Unified Medical Language System"
code "38717003" (Longitudinal (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Cross-section |
|
code "C0010362" (Cross-Sectional Studies (Research Activity)) from code system "Unified Medical Language System"
|
| Cross-section ad-hoc follow-up |
|
|
| Time series |
|
code "C0814865" (time series study (Research Activity)) from code system "Unified Medical Language System"
|
| Quality control |
|
code "C0034378" (quality control (Functional Concept)) from code system "Unified Medical Language System"
|
| Registry |
|
|
| Other |
|
code "C1556044" (other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Unknown |
|
code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set required study_type_UMLS (version DYNAMIC)
|
|
| Value Set required study_type_SCT (version DYNAMIC)
|
|
|
|
study_type_interventional
nfdhtfcov19-dataelement-98
|
|
|
| Id |
nfdhtfcov19-dataelement-98 (2022‑07‑21 15:11:25)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Single Group |
|
code "C2826346" (Single Group Study (Research Activity)) from code system "Unified Medical Language System"
|
| Parallel |
|
code "C2826345" (Parallel Study (Research Study)) from code system "Unified Medical Language System"
|
| Crossover |
|
code "C0150097" (Cross-Over Studies (Research Activity)) from code system "Unified Medical Language System"
|
| Factorial |
|
code "C2826344" (Factorial Study (Research Study)) from code system "Unified Medical Language System"
|
| Sequential |
|
code "C4553402" (Group Sequential Design (Research Activity)) from code system "Unified Medical Language System"
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Unknown |
|
code "C1556044" (other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set required study_type_UMLS (version DYNAMIC)
|
|
| Value Set required study_type_SCT (version DYNAMIC)
|
|
|
|
study_groups_of_diseases
nfdhtfcov19-dataelement-36
|
|
|
|
|
study_groups_of_diseases_generally
nfdhtfcov19-dataelement-45
|
|
|
|
|
study_groups_of_diseases_incident_outcomes
nfdhtfcov19-dataelement-48
|
|
|
| Id |
nfdhtfcov19-dataelement-48 (2022‑07‑11 10:09:36)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Yes |
|
code "C5399964" (Yes (Finding)) from code system "Unified Medical Language System"
code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
|
| No |
|
code "C1298908" (No (Finding)) from code system "Unified Medical Language System"
code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set 2.16.840.1.113883.3.1937.777.64.11.1 (version DYNAMIC)
|
|
|
|
study_groups_of_diseases_prevalent_outcomes
nfdhtfcov19-dataelement-25
|
|
|
| Id |
nfdhtfcov19-dataelement-25 (2022‑07‑09 08:30:01)
|
| Description |
Any additional descriptive information explaining terms and conditions for the (re-)use
of the resource. For example, if “Other” is selected in the property above, the preferred license or
re-use terms and conditions must be specified here.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Yes |
|
code "C5399964" (Yes (Finding)) from code system "Unified Medical Language System"
code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
|
| No |
|
code "C1298908" (No (Finding)) from code system "Unified Medical Language System"
code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set 2.16.840.1.113883.3.1937.777.64.11.1 (version DYNAMIC)
|
|
|
|
study_groups_of_diseases_generally
nfdhtfcov19-dataelement-37
|
|
|
| Id |
nfdhtfcov19-dataelement-37 (2022‑07‑09 09:07:41)
|
| Description |
If applicable, phone number associated with the contributor. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Certain infectious or parasitic diseases (01) |
|
code "66454-0" (Infectious disease [PhenX]) from code system "LOINC"
code "414022008" (Disorder of cellular component of blood (disorder)) from code system "Unified Medical Language System"
code "C0694449" (Certain infectious and parasitic diseases (A00-B99) ) from code system "Unified Medical Language System"
|
| Neoplasms (02) |
|
code "C0027651" (Neoplasms ) from code system "Unified Medical Language System"
|
| Diseases of the blood or blood-forming organs (03) |
|
code "78044-5" (Disease assessed [Identifier] Blood or Tissue) from code system "LOINC"
code "C0018939" (Hematological Disease ) from code system "Unified Medical Language System"
|
| Diseases of the immune system (04) |
|
code "C0021053" (Immune System Diseases ) from code system "Unified Medical Language System"
|
| Endocrine, nutritional or metabolic diseases (05) |
|
code "C2359470" (Endocrine, metabolic or nutritional diseases or conditions ) from code system "Unified Medical Language System"
|
| Mental, behavioural or neurodevelopmental disorders (06) |
|
code "C3263949" (Mental, Behavioral and Neurodevelopmental disorders (F01-F99) ) from code system
"Unified Medical Language System"
|
| Sleep-wake disorders (07) |
|
code "271794005" (Disorder of sleep-wake cycle (disorder)) from code system "Unified Medical Language System"
code "C0851578" (Sleep Disorders ) from code system "Unified Medical Language System"
|
| Diseases of the nervous system (08) |
|
code "118940003" (Disorder of nervous system (disorder)) from code system "Unified Medical Language System"
code "C0027765" (nervous system disorder ) from code system "Unified Medical Language System"
|
| Diseases of the visual system (09) |
|
code "C0042790" (Vision Disorders ) from code system "Unified Medical Language System"
|
| Diseases of the ear or mastoid process (10) |
|
|
| Diseases of the circulatory system (11) |
|
code "2669950" (History of cardiovascular disease (situation)) from code system "Unified Medical Language System"
code "C0728936" (Disorder of circulatory system ) from code system "Unified Medical Language System"
|
| Diseases of the respiratory system (12) |
|
code "50043002" (Disorder of respiratory system (disorder) ) from code system "Unified Medical Language System"
code "C0035204" (Respiration Disorders ) from code system "Unified Medical Language System"
|
| Diseases of the digestive system (13) |
|
code "53619000" (Disorder of digestive system (disorder)) from code system "Unified Medical Language System"
code "C0012242" (Digestive System Disorders ) from code system "Unified Medical Language System"
|
| Diseases of the skin (14) |
|
code "95320005" (Disorder of skin (disorder) |) from code system "Unified Medical Language System"
code "C0037274" (Dermatologic disorders ) from code system "Unified Medical Language System"
|
| Diseases of the musculoskeletal system or connective tissue (15) |
|
code "128481000" (Acute disease of musculoskeletal system (disorder) |) from code system "Unified Medical Language System"
code "C0026857" (Musculoskeletal Diseases ) from code system "Unified Medical Language System"
|
| Diseases of the genitourinary system (16) |
|
code "C0080276" (Urogenital Diseases ) from code system "Unified Medical Language System"
code "128290005" (Chronic disease of genitourinary system (disorder) ) from code system "SNOMED Clinical Terms"
|
| Conditions related to sexual health (17) |
|
code "C2362326" (Sexual Health ) from code system "Unified Medical Language System"
|
| Pregnancy, childbirth or the puerperium (18) |
|
code "C0694456" (Pregnancy, childbirth and the puerperium ) from code system "Unified Medical Language System"
|
| Certain conditions originating in the perinatal period (19) |
|
code "C0178307" (Certain conditions originating in the perinatal period (P00-P96) ) from code system
"Unified Medical Language System"
|
| Developmental anomalies (20) |
|
|
| Symptoms, signs or clinical findings, not elsewhere classified (21) |
|
code "C0694459" (Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
(R00-R99) ) from code system "Unified Medical Language System"
|
| Injury, poisoning or certain other consequences of external causes (22) |
|
code "71677004" (Injury due to exposure to external cause (disorder) ) from code system "Unified Medical Language System"
code "C0694460" (Injury, poisoning and certain other consequences of external causes ) from code
system "Unified Medical Language System"
|
| External causes of morbidity or mortality (23) |
|
code "C0478681" (External causes of morbidity and mortality ) from code system "Unified Medical Language System"
|
| Factors influencing health status or contact with health services (24) |
|
code "C0178336" (Factors influencing health status and contact with health services (Z00-Z99) )
from code system "Unified Medical Language System"
|
| Other |
|
code "74964007" (Other (qualifier value)) from code system "Unified Medical Language System"
code "C0205394" (Other ) from code system "Unified Medical Language System"
|
| Not applicable |
|
code "385432009" (Not applicable (qualifier value)) from code system "Unified Medical Language System"
code "C1272460" (Not Applicable ) from code system "Unified Medical Language System"
|
| Unknown |
|
code "261665006" (Unknown (qualifier value)) from code system "Unified Medical Language System"
code "C0439673" (Unknown ) from code system "Unified Medical Language System"
|
|
| Value Set study_groups_of_diseases_generally_LOINC (version DYNAMIC)
|
|
| Value Set study_groups_of_diseases_generally_SCT (version DYNAMIC)
|
|
| Value Set study_groups_of_diseases_generally_UMLS (version DYNAMIC)
|
|
|
|
study_status
nfdhtfcov19-dataelement-49
|
|
|
|
|
study_status
nfdhtfcov19-dataelement-7.5
|
|
|
| Id |
nfdhtfcov19-dataelement-7.5 (2020‑01‑15)
|
| Description |
Overall recruitment status for the study. If at least one study site in a multicenter study has the status of "Ongoing," then
the overall status for the study must be "Ongoing."
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| At the planning stage Ongoing (I): Recruitment ongoing, but data collection not yet
started
|
|
code "C2347525" (Planned Clinical Study (Functional Concept)) from code system "Unified Medical Language System"
code "C0681871" (study planning (Research Activity)) from code system "Unified Medical Language System"
|
| Ongoing (II): Recruitment and data collection ongoing |
|
code "C2347179" (Active Study (Functional Concept)) from code system "Unified Medical Language System"
|
| Ongoing (III): Recruitment completed, but data collection ongoing |
|
|
| Ongoing (IV): Recruitment and data collection completed, but data quality management
ongoing
|
|
|
| Suspended: Recruitment, data collection, or data quality management, halted, but potentially
will resume
|
|
|
| Terminated: Recruitment, data collection, data and quality management halted prematurely
and will not resume
|
|
|
| Completed: Recruitment, data collection, and data quality management completed normally
|
|
|
| Other |
|
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set required study_status_UMLS (version DYNAMIC)
|
|
| Value Set required study_status_SCT (version DYNAMIC)
|
|
|
|
study_status_halted_stage
nfdhtfcov19-dataelement-7.8
|
|
|
| Id |
nfdhtfcov19-dataelement-7.8 (2020‑01‑15)
|
| Description |
If the study was stopped prematurely, specification of the stage at what it was halted. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| At the planning stage |
|
code "C0681871" (study planning (Research Activity)) from code system "Unified Medical Language System"
|
| Ongoing (I): Recruitment ongoing, but data collection not yet started |
|
|
| Ongoing (I): Recruitment ongoing, but data collection not yet started |
|
|
| Ongoing (I): Recruitment ongoing, but data collection not yet started |
|
|
| Ongoing (IV): Recruitment and data collection completed, but data quality management
ongoing
|
|
|
|
| Value Set study_status_halted_stage_UMLS (version DYNAMIC)
|
|
|
|
study_status_when_in_intervention
nfdhtfcov19-dataelement-7.7
|
|
|
| Id |
nfdhtfcov19-dataelement-7.7 (2020‑01‑15)
|
| Description |
Specification whether study participants receive intervention or have completed it
but are still being followed according to the primary objective of the study.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Intervention ongoing |
|
code "303350001" (Ongoing episode (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Intervention completed |
|
code "255594003" (Complete (qualifier value)) from code system "SNOMED Clinical Terms"
|
| follow-up ongoing |
|
code "C3846059" (Active Follow-up Case (Finding) ) from code system "Unified Medical Language System"
code "C0589120" (Follow-up status (Finding) ) from code system "Unified Medical Language System"
code "399350006" (Under follow-up (finding)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_status_when_intervention_SCT (version 2022‑07‑06 22:58:08)
|
|
|
|
study_status_enrolling_by_invitation
nfdhtfcov19-dataelement-7.6
|
|
|
| Id |
nfdhtfcov19-dataelement-7.6 (2020‑01‑15)
|
| Description |
Specification whether study participants have been selected from a predetermined population
or enrolled by invitation.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Yes |
|
code "C5399964" (Yes (Finding) ) from code system "Unified Medical Language System"
code "C1705108" (Yes (indicator) (Finding)) from code system "Unified Medical Language System"
code "780816009" (Invitation to participate in research study (procedure)) from code system "SNOMED Clinical Terms"
code "373066001" (Yes (qualifier value)) from code system "SNOMED Clinical Terms"
|
| No |
|
code "C1298908" (No (Finding)) from code system "Unified Medical Language System"
code "373067005" (No (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Not Applicable |
|
code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set Yes_No_Unknown (version DYNAMIC)
|
|
|
|
study_data_source
nfdhtfcov19-dataelement-51
|
|
|
|
|
study_data_sources_general
nfdhtfcov19-dataelement-55
|
|
|
|
|
study_data_sources_biosamples
nfdhtfcov19-dataelement-59
|
|
|
| Id |
nfdhtfcov19-dataelement-59 (2022‑07‑11 10:37:10)
|
| Description |
Sources from which the data are generated or extracted. |
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Blood |
|
code "C0005767" (Blood (Body Substance)) from code system "Unified Medical Language System"
code "119297000" (Blood specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| buccal cells |
|
code "C5419552" (Buccal Cell Sample (Cell)) from code system "Unified Medical Language System"
code "258564008" (Buccal smear sample (specimen)) from code system "SNOMED Clinical Terms"
|
| Cord Blood |
|
code "C0162371" (Umbilical Cord Blood (Body Substance)) from code system "Unified Medical Language System"
code "122556008" (Cord blood specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| DNA |
|
code "C0012854" (DNA (Nucleic Acid, Nucleoside, or Nucleotide · Biologically Active Substance))
from code system "Unified Medical Language System"
|
| Faeces |
|
code "C0015733" (Feces (Body Substance)) from code system "Unified Medical Language System"
code "119339001" (Stool specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Hair |
|
code "C0444095" (Hair Specimen (Body Substance)) from code system "Unified Medical Language System"
code "119326000" (Hair specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Immortalized cell lines |
|
code "C0178708" (immortalized cell (Cell)) from code system "Unified Medical Language System"
|
| Isolated pathogen |
|
|
| Nail |
|
code "C0444077" (Nail Specimen (Body Substance)) from code system "Unified Medical Language System"
code "119327009" (Nail specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Plasma |
|
code "C1609077" (Plasma - SpecimenType (Body Substance)) from code system "Unified Medical Language System"
code "C0032105" (Plasma (Body Substance)) from code system "Unified Medical Language System"
code "119361006" (Plasma specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| RNA |
|
code "C0035668" (RNA (Nucleic Acid, Nucleoside, or Nucleotide)) from code system "Unified Medical Language System"
code "27888000" (Ribonucleic acid (substance)) from code system "SNOMED Clinical Terms"
|
| Saliva |
|
code "C0438730" (Saliva specimen (Body Substance)) from code system "Unified Medical Language System"
code "C0036087" (Saliva (Body Substance)) from code system "Unified Medical Language System"
code "119342007" (Saliva specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Serum |
|
code "C1550100" (Specimen Type - Serum (Body Substance)) from code system "Unified Medical Language System"
code "C0229671" (Serum (Body Substance)) from code system "Unified Medical Language System"
|
| Tissue (Frozen) |
|
code "C4764221" (Frozen Tissue (Tissue)) from code system "Unified Medical Language System"
code "16214131000119104" (Frozen tissue section sample (specimen)) from code system "SNOMED Clinical Terms"
|
| Tissue (FFPE) |
|
code "C2711483" (Formalin-fixed paraffin-embedded tissue specimen (Tissue)) from code system "Unified Medical Language System"
code "C5419553" (Formalin-Fixed Paraffin-Embedded Tissue Sample (Tissue)) from code system "Unified Medical Language System"
code "441652008" (Formalin-fixed paraffin-embedded tissue specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Urine |
|
code "C1610733" (Urine - SpecimenType (Body Substance)) from code system "Unified Medical Language System"
code "C0042036" (Urine (Body Substance)) from code system "Unified Medical Language System"
code "122575003" (Urine specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Other biological samples |
|
code "123038009" (Specimen (specimen)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_data_source_UMLS (version DYNAMIC)
|
|
| Value Set study_data_source_SCT (version DYNAMIC)
|
|
| Value Set study_data_source_LOINC (version DYNAMIC)
|
|
|
|
study_data_sources_imaging
nfdhtfcov19-dataelement-57
|
|
|
| Id |
nfdhtfcov19-dataelement-57 (2022‑07‑11 10:33:04)
|
| Description |
Sources from which the data are generated or extracted. |
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Imaging data (Ultrasound) |
|
code "C3887754" (Ultrasonogram (Manufactured Object)) from code system "Unified Medical Language System"
|
| Imaging data (MRI) |
|
code "C5392999" (Magnetic Resonance Image (Intellectual Product)) from code system "Unified Medical Language System"
code "C3890166" (Magnetic Resonance Imaging Study File (Intellectual Product)) from code system
"Unified Medical Language System"
|
| Imaging data (MRI, radiography) |
|
code "C1306645" (Plain x-ray (Diagnostic Procedure)) from code system "Unified Medical Language System"
code "C3891450" (Radiography Study File (Intellectual Product) ) from code system "Unified Medical Language System"
|
| Imaging data (CT) |
|
code "C1522465" (Tomogram (Manufactured Object)) from code system "Unified Medical Language System"
code "C3888140" (Computed Tomography Study File (Intellectual Product)) from code system "Unified Medical Language System"
|
| Other imaging data |
|
code "C2015796" (other imaging studies (Diagnostic Procedure)) from code system "Unified Medical Language System"
|
|
| Value Set study_data_source_LOINC (version DYNAMIC)
|
|
| Value Set study_data_source_SCT (version DYNAMIC)
|
|
| Value Set study_data_source_UMLS (version DYNAMIC)
|
|
|
|
study_data_sources_omics
nfdhtfcov19-dataelement-56
|
|
|
|
|
study_data_source_general
nfdhtfcov19-dataelement-7.13
|
|
|
| Id |
nfdhtfcov19-dataelement-7.13 (2020‑01‑15)
|
| Description |
Sources from which the data are generated or extracted. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Biological samples |
|
code "123038009" (Specimen (specimen)) from code system "SNOMED Clinical Terms"
|
| Administrative databases |
|
code "C0242356" (Databases (Intellectual Product) C0242356 unpräzise) from code system "Unified Medical Language System"
|
| Cognitive Measurements |
|
code "C2237115" (Assessment of cognitive functions (Health Care Activity) ) from code system "Unified Medical Language System"
code "113024001" (Assessment and interpretation of higher cerebral function, cognitive testing (procedure))
from code system "SNOMED Clinical Terms"
|
| Genealogical records |
|
code "84100007" (History taking (procedure)) from code system "SNOMED Clinical Terms"
code "5491000179105" (Medical record summary (record artifact)) from code system "SNOMED Clinical Terms"
code "129465004" (Medical record, device (physical object)) from code system "SNOMED Clinical Terms"
|
| Imaging data |
|
code "C3887754" (Ultrasonogram (Manufactured Object)) from code system "Unified Medical Language System"
|
| Medical records |
|
code "74735-2" (Health data repository [Identifier]) from code system "LOINC"
code "11503-0" (Medical records) from code system "LOINC"
code "C0025102" (Medical Records (Intellectual Product)) from code system "Unified Medical Language System"
|
| Interview |
|
code "C0021822" (Interview (Activity)) from code system "Unified Medical Language System"
|
| Questionnaire |
|
code "C0034394" (Questionnaires (Intellectual Product)) from code system "Unified Medical Language System"
|
| Physiological/Biochemical measurements |
|
code "C0242485" (Measurement (Functional Concept)) from code system "Unified Medical Language System"
code "64777005" (Physiologic measurement (procedure)) from code system "SNOMED Clinical Terms"
|
| Omics technology |
|
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_data_source_LOINC (version DYNAMIC)
|
|
| Value Set study_data_source_SCT (version DYNAMIC)
|
|
| Value Set study_data_source_UMLS (version DYNAMIC)
|
|
|
|
study_interventions
nfdhtfcov19-dataelement-82
|
|
|
|
|
study_intervention_type
nfdhtfcov19-dataelement-8.1
|
|
|
| Id |
nfdhtfcov19-dataelement-8.1 (2020‑01‑15)
|
| Synonym |
study_intervention_type
|
| Description |
Specification of the intervention(s) associated with each arm or group; at least one
intervention must be specified.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Drug (including placebo) |
|
code "C0013227" (Pharmaceutical Preparations (Pharmacologic Substance)) from code system "Unified Medical Language System"
code "410942007" (Drug or medicament (substance)) from code system "SNOMED Clinical Terms"
|
| Device (including sham) |
|
code "C0699733" (Devices (Manufactured Object)) from code system "Unified Medical Language System"
code "49062001" (Device (physical object)) from code system "SNOMED Clinical Terms"
|
| Biological/Vaccine |
|
code "C3842488" (Other biologicals (Therapeutic or Preventive Procedure)) from code system "Unified Medical Language System"
code "C0541491" (Drugs and Biologicals (Clinical Drug)) from code system "Unified Medical Language System"
code "C0042210" (Vaccines (Amino Acid, Peptide, or Protein, Pharmacologic Substance, Immunologic
Factor)) from code system "Unified Medical Language System"
code "787859002" (Vaccine product (product)) from code system "SNOMED Clinical Terms"
code "115668003" (Biological substance (substance)) from code system "SNOMED Clinical Terms"
|
| Procedure/Surgery |
|
code "387713003" (Surgical procedure (procedure)) from code system "SNOMED Clinical Terms"
code "71388002" (Procedure (procedure)) from code system "SNOMED Clinical Terms"
|
| Radiation |
|
code "C0851346" (Radiation (Natural Phenomenon or Process)) from code system "Unified Medical Language System"
code "108290001" (Radiation oncology AND/OR radiotherapy (procedure)) from code system "SNOMED Clinical Terms"
code "82107009" (Radiation (physical force)) from code system "SNOMED Clinical Terms"
|
| Behavioral (e.g., psychotherapy, lifestyle counseling) |
|
code "C0004939" (Behavioral Research (Research Activity)) from code system "Unified Medical Language System"
code "C0004927" (Behavior (Behavior)) from code system "Unified Medical Language System"
code "75516001" (Psychotherapy (regime/therapy)) from code system "SNOMED Clinical Terms"
code "166001" (Behavioral therapy (regime/therapy)) from code system "SNOMED Clinical Terms"
|
| Genetic (including gene transfer, stem cell and recombinant DNA) |
|
code "C0017296" (Gene therapy (Therapeutic or Preventive Procedure)) from code system "Unified Medical Language System"
code "C0314603" (Genetic (Functional Concept)) from code system "Unified Medical Language System"
|
| Dietary supplement (e.g., vitamins, minerals) |
|
code "C0242295" (Dietary Supplements (Food)) from code system "Unified Medical Language System"
code "709542007" (Administration of nutritional supplement (procedure)) from code system "SNOMED Clinical Terms"
|
| 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 "C1880146" (Combination Product (Manufactured Object)) from code system "Unified Medical Language System"
|
| Diagnostic test (e.g., imaging, in-vitro) |
|
code "C0086143" (Diagnostic tests (Diagnostic Procedure)) from code system "Unified Medical Language System"
code "103693007" (Diagnostic procedure (procedure)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_intervention_type_SCT (version DYNAMIC)
|
|
| Value Set study_intervention_type_UMLS (version DYNAMIC)
|
|
|
|
study_sampling_method
nfdhtfcov19-dataelement-54
|
|
|
|
|
study_sampling_method
nfdhtfcov19-dataelement-52
|
|
|
| Id |
nfdhtfcov19-dataelement-52 (2022‑07‑11 10:15:45)
|
| Description |
Type of the sampling method applied for the selection of study participants. |
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Probability |
|
code "C0033204" (Probability (Qualitative Concept)) from code system "Unified Medical Language System"
|
| Non-probability |
|
code "C4288587" (Non-Probability Sampling Method (Research Activity)) from code system "Unified Medical Language System"
|
| Mixed probability and non-probability |
|
|
| Total universe/Complete enumeration |
|
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Unknown |
|
code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Not applicable |
|
code "C1272460" (Not Applicable (Qualitative Concept)) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_sampling_SCT (version DYNAMIC)
|
|
| Value Set study_sampling_UMLS (version DYNAMIC)
|
|
|
|
study_sampling_method_probability
nfdhtfcov19-dataelement-53
|
|
|
| Id |
nfdhtfcov19-dataelement-53 (2022‑07‑11 10:28:05)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Probability (Simple random) |
|
code "C0681878" (Simple Random Sampling (Quantitative Concept)) from code system "Unified Medical Language System"
|
| Probability (Systematic random) |
|
code "C1710275" (Systematic Sampling (Quantitative Concept)) from code system "Unified Medical Language System"
|
| Probability (Stratified) |
|
code "C0681883" (Stratified Sampling (Research Activity)) from code system "Unified Medical Language System"
|
| Probability (Stratified: Proportional) |
|
code "C2347696" (Proportional Stratified Sampling (Quantitative Concept)) from code system "Unified Medical Language System"
|
| Probability (Stratified: Disproportional) |
|
code "C2348304" (Disproportional Stratified Sampling (Quantitative Concept)) from code system "Unified Medical Language System"
|
| Probability (Cluster) |
|
code "C2347812" (Cluster Random Sampling (Quantitative Concept)) from code system "Unified Medical Language System"
|
| Probability (Cluster: Simple random) |
|
code "C2347394" (One-Stage Cluster Random Sampling (Research Activity)) from code system "Unified Medical Language System"
|
| Probability (Cluster: Stratified random) |
|
code "C0681879" (Stratified Random Sampling) from code system "Unified Medical Language System"
|
| Probability (Multistage) |
|
code "C2347298" (Multi-Stage Cluster Random Sampling (Research Activity)) from code system "Unified Medical Language System"
code "C0814873" (multistage sampling design (Research Activity) (C0814873)) from code system "Unified Medical Language System"
|
|
| Value Set study_sampling_SCT (version DYNAMIC)
|
|
| Value Set study_sampling_UMLS (version DYNAMIC)
|
|
|
|
study_sampling_method_non_probability
nfdhtfcov19-dataelement-7.12
|
|
|
| Id |
nfdhtfcov19-dataelement-7.12 (2020‑01‑15)
|
| Description |
Type of the sampling method applied for the selection of study participants. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Non-probability (Availability) |
|
code "C0150095" (Convenience Sampling (Research Activity)) from code system "Unified Medical Language System"
|
| Non-probability (Purposive) |
|
code "C0681880" (Matched Sampling (Research Activity)) from code system "Unified Medical Language System"
|
| Non-probability (Quota) |
|
code "C2347740" (Quota Sampling (Research Activity)) from code system "Unified Medical Language System"
|
| Non-probability (Respondent-assisted) |
|
|
|
| Value Set study_sampling_SCT (version DYNAMIC)
|
|
| Value Set study_sampling_UMLS (version DYNAMIC)
|
|
|
|
study_eligibility_age_min
nfdhtfcov19-dataelement-60
|
|
|
|
|
time_unit
nfdhtfcov19-dataelement-65
|
|
|
| Id |
nfdhtfcov19-dataelement-65 (2022‑07‑11 11:58:14)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Years |
|
code "C0439234" (Year ) from code system "Unified Medical Language System"
code "258707000" (year (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Months |
|
code "C0439231" (Month ) from code system "Unified Medical Language System"
code "258706009" (month (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks |
|
code "C0439230" (Week ) from code system "Unified Medical Language System"
code "258705008" (week (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Days |
|
code "C0439228" (Day ) from code system "Unified Medical Language System"
code "258703001" (day (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Hours |
|
code "C0439227" (Hour ) from code system "Unified Medical Language System"
code "258702006" (hour (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Minutes |
|
code "C0439232" (Minute of time ) from code system "Unified Medical Language System"
code "1156209001" (minute (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks of gestation |
|
code "C1135241" (Weeks pregnant ) from code system "Unified Medical Language System"
|
|
| Value Set time_SCT (version DYNAMIC)
|
|
| Value Set time_UMLS (version DYNAMIC)
|
|
|
|
study_eligibility_age_max
nfdhtfcov19-dataelement-61
|
|
|
|
|
time_unit
nfdhtfcov19-dataelement-68
|
|
|
| Id |
nfdhtfcov19-dataelement-68 (2022‑07‑11 11:59:47)
|
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Years |
|
code "C0439234" (Year ) from code system "Unified Medical Language System"
code "258707000" (year (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Months |
|
code "C0439231" (Month ) from code system "Unified Medical Language System"
code "258706009" (month (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks |
|
code "C0439230" (Week ) from code system "Unified Medical Language System"
code "258705008" (week (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Days |
|
code "C0439228" (Day ) from code system "Unified Medical Language System"
code "258703001" (day (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Hours |
|
code "C0439227" (Hour ) from code system "Unified Medical Language System"
code "258702006" (hour (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Minutes |
|
code "C0439232" (Minute of time ) from code system "Unified Medical Language System"
code "1156209001" (minute (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks of gestation |
|
code "C1135241" (Weeks pregnant ) from code system "Unified Medical Language System"
|
|
| Value Set time_UMLS (version DYNAMIC)
|
|
| Value Set time_SCT (version DYNAMIC)
|
|
|
|
study_eligibility_age_min_examined
nfdhtfcov19-dataelement-62
|
|
|
|
|
time_unit
nfdhtfcov19-dataelement-67
|
|
|
| Id |
nfdhtfcov19-dataelement-67 (2022‑07‑11 11:59:23)
|
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Years |
|
code "C0439234" (Year ) from code system "Unified Medical Language System"
code "258707000" (year (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Months |
|
code "C0439231" (Month ) from code system "Unified Medical Language System"
code "258706009" (month (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks |
|
code "C0439230" (Week ) from code system "Unified Medical Language System"
code "258705008" (week (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Days |
|
code "C0439228" (Day ) from code system "Unified Medical Language System"
code "258703001" (day (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Hours |
|
code "C0439227" (Hour ) from code system "Unified Medical Language System"
code "258702006" (hour (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Minutes |
|
code "C0439232" (Minute of time ) from code system "Unified Medical Language System"
code "1156209001" (minute (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks of gestation |
|
code "C1135241" (Weeks pregnant ) from code system "Unified Medical Language System"
|
|
| Value Set time_SCT (version DYNAMIC)
|
|
| Value Set time_UMLS (version DYNAMIC)
|
|
|
|
study_eligibility_age_max_examined
nfdhtfcov19-dataelement-63
|
|
|
|
|
time_unit
nfdhtfcov19-dataelement-66
|
|
|
| Id |
nfdhtfcov19-dataelement-66 (2022‑07‑11 11:58:45)
|
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Years |
|
code "C0439234" (Year ) from code system "Unified Medical Language System"
code "258707000" (year (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Months |
|
code "C0439231" (Month ) from code system "Unified Medical Language System"
code "258706009" (month (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks |
|
code "C0439230" (Week ) from code system "Unified Medical Language System"
code "258705008" (week (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Days |
|
code "C0439228" (Day ) from code system "Unified Medical Language System"
code "258703001" (day (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Hours |
|
code "C0439227" (Hour ) from code system "Unified Medical Language System"
code "258702006" (hour (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Minutes |
|
code "C0439232" (Minute of time ) from code system "Unified Medical Language System"
code "1156209001" (minute (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Weeks of gestation |
|
code "C1135241" (Weeks pregnant ) from code system "Unified Medical Language System"
|
|
| Value Set time_SCT (version DYNAMIC)
|
|
| Value Set time_UMLS (version DYNAMIC)
|
|
|
|
study_primary_design
nfdhtfcov19-dataelement-7.1
|
|
|
| Id |
nfdhtfcov19-dataelement-7.1 (2020‑01‑15)
|
| Description |
The primary design of a study. Select between interventional and non- interventional
study design.
Non-interventional study design refers to a study that does not aim to alter study
outcomes of interest.
Interventional study design refers to a study that aims to alter study outcomes of
interest.
|
| Relationship |
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Non-interventional |
|
code "C4684718" (Non-Interventional Study (Research Activity)) from code system "Unified Medical Language System"
|
| Interventional |
|
code "C3274035" (Interventional Study (Research Study)) from code system "Unified Medical Language System"
|
|
| Value Set required study_primary_design_UMLS (version DYNAMIC)
|
|
|
|
study_primary_purpose
nfdhtfcov19-dataelement-8.2
|
|
|
| Id |
nfdhtfcov19-dataelement-8.2 (2020‑01‑15)
|
| Description |
The main objective of the intervention(s) being evaluated by the study.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Treatment |
|
code "C3161471" (Treatment Study (Research Study)) from code system "SNOMED Clinical Terms"
code "262202000" (Therapeutic intent (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Prevention |
|
code "C1706420" (Prevention Study (Research Study)) from code system "SNOMED Clinical Terms"
code "129428001" (Preventive - procedure intent (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Prognostic |
|
code "C0220901" (prognostic (Intellectual Product)) from code system "SNOMED Clinical Terms"
code "20481000" (Determination of prognosis (procedure)) from code system "SNOMED Clinical Terms"
code "170967006" (Prognosis/outlook (observable entity)) from code system "SNOMED Clinical Terms"
|
| Diagnostic |
|
code "C1704656" (Diagnosis Study (Research Study)) from code system "SNOMED Clinical Terms"
code "261004008" (Diagnostic intent (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Supportive |
|
code "C2348611" (Supportive Care Study (Research Study)) from code system "SNOMED Clinical Terms"
code "399707004" (Supportive - procedure intent (qualifier value)) from code system "SNOMED Clinical Terms"
code "243114000" (Support (regime/therapy)) from code system "SNOMED Clinical Terms"
|
| Care |
|
|
| Screening |
|
code "C2348164" (Screening Study (Research Activity)) from code system "SNOMED Clinical Terms"
code "360156006" (Screening - procedure intent (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Health Services Research |
|
code "C0018757" (Health Services Research (Research Activity)) from code system "SNOMED Clinical Terms"
|
| Basic Science/Physiological study |
|
code "C0681833" (Basic Research (Research Activity)) from code system "SNOMED Clinical Terms"
|
| Device Feasibility |
|
code "C4528315" (Device Feasibility Study (Research Activity)) from code system "SNOMED Clinical Terms"
|
| Pharmacogenetics |
|
code "C0031325" (Pharmacogenetics (Biomedical Occupation or Discipline)) from code system "SNOMED Clinical Terms"
|
| Pharmacogenomics |
|
code "C1138555" (Pharmacogenomics (Biomedical Occupation or Discipline)) from code system "SNOMED Clinical Terms"
|
| Health Economics |
|
code "C5241252" (Health Economics (Occupational Activity)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "SNOMED Clinical Terms"
code "C0205394" (Other (Qualitative Concept)) from code system "SNOMED Clinical Terms"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_primary_purpose_SCT (version DYNAMIC)
|
|
| Value Set study_primary_purpose_UMLS (version DYNAMIC)
|
|
|
|
study_ethics_commitee_approval
nfdhtfcov19-dataelement-7.4
|
|
|
| Id |
nfdhtfcov19-dataelement-7.4 (2020‑01‑15)
|
| Description |
Status of the study approval from the (leading) ethics commitee.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Request for approval not yet submitted |
|
|
| Request submitted, approval pending |
|
code "C2347793" (Clinical Study Site Pending IRB Approval (Functional Concept)) from code system
"Unified Medical Language System"
|
| Request submitted, approval granted |
|
code "C2346846" (Approved Protocol - clinical study status (Functional Concept)) from code system
"Unified Medical Language System"
|
| Request submitted, exempt granted |
|
|
| Request submitted, approval denied |
|
code "C2347711" (Protocol Disapproved (Functional Concept)) from code system "Unified Medical Language System"
|
| Approval not required |
|
code "410529002" (Not needed (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Study withdrawn prior to decision on approval |
|
code "C2348571" (Study Withdrawn (Functional Concept)) from code system "Unified Medical Language System"
|
| Unknown |
|
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_ethics_commitee_approval_SCT (version DYNAMIC)
|
|
| Value Set study_ethics_commitee_approval_UMLS (version DYNAMIC)
|
|
|
|
study_recruitment_status_register
nfdhtfcov19-dataelement-9
|
|
|
| Id |
nfdhtfcov19-dataelement-9 (2022‑06‑28 20:08:36)
|
| Description |
If the study was stopped prematurely, specification of the reason(s) why it was halted. If at least one study site in a multicenter study has the recruitment status of "Recruiting,"
then the overall recruitment status for the study must be "Recruiting."
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Not yet recruiting |
|
code "410532004" (Under consideration, not yet offered (qualifier value)) from code system "SNOMED Clinical Terms"
code "410524007" (Was not started (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Enrolling by invitation |
|
code "780816009" (Invitation to participate in research study (procedure)) from code system "SNOMED Clinical Terms"
|
| Active, not recruiting |
|
code "C1561510" (Entity Status - active (Idea or Concept)) from code system "Unified Medical Language System"
code "303350001" ( Ongoing episode (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Completed |
|
code "C3854010" (completed - RoleLinkStatus (Idea or Concept)) from code system "Unified Medical Language System"
code "255594003" (Complete (qualifier value)) from code system "SNOMED Clinical Terms"
code "385656004" (Ended (qualifier value)) from code system "SNOMED Clinical Terms"
code "385658003" (Done (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Suspended |
|
code "385655000" (Suspended (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Terminated |
|
code "C1553407" (terminated - EntityStatus (Finding)) from code system "Unified Medical Language System"
code "410546004" (Discontinued (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Withdrawn |
|
code "C0424092" (Withdrawn (Finding)) from code system "Unified Medical Language System"
|
| Other |
|
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_recruitment_status_register_SCT (version DYNAMIC)
|
|
| Value Set study_recruitment_status_register_UMLS (version DYNAMIC)
|
|
|
|
study_countries
nfdhtfcov19-dataelement-7.9
|
|
|
| Id |
nfdhtfcov19-dataelement-7.9 (2020‑01‑15)
|
| Synonym |
study_country
|
| Description |
Country or countries in which the study takes place. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Country names from the ISO 3166-1 list |
|
code "C0454664" (Country (Geographic Area)) from code system "Unified Medical Language System"
code "C5421500" (ISO 3166 Part 1 Country Codes, 2nd Edition (Intellectual Product)) from code system
"Unified Medical Language System"
code "223369002" (Country (geographic location)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_countries_UMLS (version DYNAMIC)
|
|
| Value Set study_countries_SCT (version DYNAMIC)
|
|
|
|
study_centers
nfdhtfcov19-dataelement-7.10
|
|
|
| Id |
nfdhtfcov19-dataelement-7.10 (2020‑01‑15)
|
| Synonym |
study_centers
|
| Description |
Indication, whether a study is conducted at one study site (monocenter study) or at
more than one study site (multicenter study).
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Monocentric |
|
code "C1552456" (Clinic / Center - Research (Manufactured Object ; Health Care Related Organization))
from code system "Unified Medical Language System"
|
| Multicentric |
|
code "255206009" (Multicentric (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_centers_SCT (version DYNAMIC)
|
|
| Value Set study_centers_UMLS (version DYNAMIC)
|
|
|
|
study_subject
nfdhtfcov19-dataelement-7.11
|
|
|
| Id |
nfdhtfcov19-dataelement-7.11 (2020‑01‑15)
|
| Synonym |
study_subject
|
| Description |
Primary unit of operational and/or administrative interest in the study. |
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Person |
|
code "C0681850" (Study Subject (Group)) from code system "Unified Medical Language System"
code "C0027361" (Persons (Population Group)) from code system "Unified Medical Language System"
code "C2349001" (Human Study Subject (Population Group)) from code system "Unified Medical Language System"
code "125676002" (Person (person)) from code system "SNOMED Clinical Terms"
|
| Animal |
|
code "C0003062" (Animals (Animal)) from code system "Unified Medical Language System"
code "387961004" (Kingdom Animalia (organism)) from code system "SNOMED Clinical Terms"
|
| Other |
|
code "C1556044" (Other - No Information (Idea or Concept)) from code system "Unified Medical Language System"
code "C0205394" (Other (Qualitative Concept)) from code system "Unified Medical Language System"
code "74964007" (Other (qualifier value)) from code system "SNOMED Clinical Terms"
|
| Unknown |
|
code "C0439673" (Unknown (Qualitative Concept)) from code system "Unified Medical Language System"
code "261665006" (Unknown (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set study_subject_LOINC (version DYNAMIC)
|
|
| Value Set study_subject_SCT (version DYNAMIC)
|
|
| Value Set study_subject_UMLS (version DYNAMIC)
|
|
|
|
study_eligibility_gender
nfdhtfcov19-dataelement-58
|
|
|
| Id |
nfdhtfcov19-dataelement-58 (2022‑07‑11 10:34:20)
|
| Description |
Gender of the potential participants eligible to participate in the study.
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Male |
|
code "C1706428" (Male Phenotype ) from code system "Unified Medical Language System"
code "248153007" (Male (finding)) from code system "SNOMED Clinical Terms"
|
| Female |
|
code "C1705498" (Female Phenotype ) from code system "Unified Medical Language System"
code "248152002" (Female (finding)) from code system "SNOMED Clinical Terms"
|
| Diverse |
|
|
| Not applicable |
|
code "C1272460" (Not Applicable ) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set gender_UMLS (version DYNAMIC)
|
|
| Value Set gender_SCT (version DYNAMIC)
|
|
|
|
study_eligibility_criteria
nfdhtfcov19-dataelement-64
|
|
|
| Id |
nfdhtfcov19-dataelement-64 (2022‑07‑11 11:57:36)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
Assigned references |
| Male |
|
code "C1706428" (Male Phenotype ) from code system "Unified Medical Language System"
code "248153007" (Male (finding)) from code system "SNOMED Clinical Terms"
|
| Female |
|
code "C1705498" (Female Phenotype ) from code system "Unified Medical Language System"
code "248152002" (Female (finding)) from code system "SNOMED Clinical Terms"
|
| Diverse |
|
|
| Not applicable |
|
code "C1272460" (Not Applicable ) from code system "Unified Medical Language System"
code "385432009" (Not applicable (qualifier value)) from code system "SNOMED Clinical Terms"
|
|
| Value Set gender_SCT (version DYNAMIC)
|
|
| Value Set gender_UMLS (version DYNAMIC)
|
|
|
|
provenance
nfdhtfcov19-dataelement-13
|
|
|
|
|
data_source
nfdhtfcov19-dataelement-14
|
|
|
| Id |
nfdhtfcov19-dataelement-14 (2022‑06‑30 15:18:47)
|
| Value Domain |
Code |
| Choice list |
| Concept List |
| Concept |
Description |
| Automatically uploaded: ClinicalTrials.gov |
|
| Automatically uploaded: DRKS |
|
| Automatically uploaded: |
|
| ICTRP |
|
| Automatically uploaded: MDM Portal |
|
| Automatically uploaded: Other |
|
| Manually collected |
|
|
|
|
empty_items
nfdhtfcov19-dataelement-50
|
|
|
|
|
nfdhtfcov19-dataelement-15
|
|
|
|
|
nfdhtfcov19-dataelement-27
|
|
|
|
|
nfdhtfcov19-dataelement-26
|
|
|
|
|
nfdhtfcov19-dataelement-87
|
|
|
|
|
nfdhtfcov19-dataelement-88
|
|
|
|
|
nfdhtfcov19-dataelement-85
|
|
|
|
|
nfdhtfcov19-dataelement-90
|
|
|
|
|
nfdhtfcov19-dataelement-93
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|
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nfdhtfcov19-dataelement-97
|
|
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nfdhtfcov19-dataelement-86
|
|
|
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nfdhtfcov19-dataelement-95
|
|
|
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nfdhtfcov19-dataelement-94
|
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|
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nfdhtfcov19-dataelement-47
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|
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nfdhtfcov19-dataelement-81
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|
|
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nfdhtfcov19-dataelement-96
|
|
|
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nfdhtfcov19-dataelement-69
|
|
|
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nfdhtfcov19-dataelement-84
|
|
|
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nfdhtfcov19-dataelement-70
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|
|
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nfdhtfcov19-dataelement-46
|
|
|
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|
nfdhtfcov19-dataelement-83
|
|
|
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nfdhtfcov19-dataelement-22
|
|
|
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|
nfdhtfcov19-dataelement-72
|
|
|
|
|
nfdhtfcov19-dataelement-92
|
|
|
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|
nfdhtfcov19-dataelement-73
|
|
|
|
|
nfdhtfcov19-dataelement-75
|
|
|
|
|
nfdhtfcov19-dataelement-74
|
|
|
|
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nfdhtfcov19-dataelement-76
|
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|
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nfdhtfcov19-dataelement-35
|
|
|
|
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nfdhtfcov19-dataelement-71
|
|
|
|
|
nfdhtfcov19-dataelement-24
|
|
|
|
|
nfdhtfcov19-dataelement-41
|
|
|
|
|
nfdhtfcov19-dataelement-29
|
|
|
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nfdhtfcov19-dataelement-28
|
|
|
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nfdhtfcov19-dataelement-33
|
|
|
|
|
nfdhtfcov19-dataelement-21
|
|
|
|
|
nfdhtfcov19-dataelement-38
|
|
|
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nfdhtfcov19-dataelement-20
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|
|
|
|
nfdhtfcov19-dataelement-34
|
|
|
|
|
nfdhtfcov19-dataelement-89
|
|
|
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|
empty_folders
nfdhtfcov19-dataelement-30
|
|
|
|
|