Selected Cell
Cell:
Value:
MDS-to-FHIR Mapping
Legends
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
| NFDI4Health Task Force COVID-19 Metadata Schema (MDS) | FHIR ResearchStudy | FHIR Questionnaire | FHIR DocumentReference | ||||||||||||||||||||||
| NFDI4Health.Entity | NFDI4Health.Entity.Item | Obligation: Mandatory / Recommended | Field type | Allowed Values | Data item description | General NFDI.Items (applicable for each type of NFDI resources) | NFDI.Items related to Studies only | FHIR element name | FHIR element Cardinality | FHIR element type | Values / Value Set / Terminologies | Binding strength | Studies_ Mapping_high_level | FHIR element name | FHIR element Cardinality | FHIR element type | Values / Value Set / Terminologies | Binding strength | Questionnaires_ Mapping_high_level | FHIR element name | FHIR element Cardinality | FHIR element type | Values / Value Set / Terminologies | Binding strength | Documents _Mapping_high_level |
| Resource | resource_type | Mandatory | Drop-down | Study, Substudy, Dataset, StudyProtocol, ProtocolAmendment, DataDictionary, InformedConsentForm, PatientInformationSheet, Manual of Operations (SOPs), StatisticalAnalysisPlan, DataManagementPlan, CaseReportForm, CodeBook, Questionnaire, InterviewSchemeAndThemes, ObservationGuide, DiscussionGuide, ParticipantTasks, OtherDataCollectionInstrument, OtherStudyDocument, Other | A short description of the resource. | 1 | 0 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
| Resource | resource_type_general | Mandatory | Drop-down | Audiovisual, Collection, DataPaper, Dataset, Event, Image, InteractiveResource, Model, PhysicalObject, Service, Software, Sound, Text, Workflow, Other | A more general description of the resource. It is used to enable DOI-assignment. The categories are predefined by DataCite. For category definitions and examples, see the latest version of the DataCite Metadata Schema at https://schema.datacite.org/. | 1 | 0 | ResearchStudy.extension[Resource_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.extension[Resource_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.extension[Resource_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 |
| Resource | resource_language | Recommended | Drop-down | EN (English), DE (German), ES (Spanish), FR (French) | The primary language of the resource. | 1 | 0 | ResearchStudy.language | 0..1 | Code | Common Languages | Preferred | 0 | Questionnaire.language | 0..1 | Code | Common Languages | Preferred | 0 | DocumentReference.language | 0..1 | Code | Common Languages | Preferred | 0 |
| Resource | resource_use_rights | Mandatory | Text | CC BY 4.0, CC BY-ND 4.0, N/A, Other | License defining the rights to re-use the resource. In lines with the FAIR Guiding Principles, an open license is preferred. | 1 | 0 | ResearchStudy.extension[Use_rights].valueString | 0..1 | String | -9 | -9 | 1 | Questionnaire.copyright | 0..1 | markdown | -9 | -9 | 0 | DocumentReference.extension[Use_rights].valueString | 0..1 | String | -9 | -9 | 1 |
| Resource | resource_web_page | Recommended | Text | - | If existing, the web page directly relevant to the resource. | 1 | 0 | ResearchStudy.RelatedArtifact.type + ResearchStudy.RelatedArtifact.url + ResearchStudy.RelatedArtifact.label | 1..1 / 0..1 / 0..1 | code / url / String | RelatedArtifactType: documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of / -9 / -9 | Required / -9 / -9 | 0 | Questionnaire.extension[Webpage].valueUrl | 0..1 | url | url | Required | 1 | DocumentReference.Content.attachment | 1..1 | Attachment | Document or URL | Required | 0 |
| ResourceDescription | description_text | Mandatory | Text | - | A short plain text summary describing the resource in English. The provided information should be understandable by a scientific audience. The description must be written in English. Additionally, text in German can be provided. | 1 | 0 | ResearchStudy.description | 0..1 | markdown | -9 | -9 | 0 | Questionnaire.description | 0..1 | markdown | -9 | -9 | 0 | DocumentReference.Description | 0..1 | string | -9 | -9 | 0 |
| ResourceDescription | description_language | Mandatory | Drop-down | EN (English), DE (German) | Language of the description. | 1 | 0 | ResearchStudy.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | Questionnaire.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | DocumentReference.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 |
| ResourceTitle | title | Mandatory | Text | - | Scientific unabbreviated title of the resource. The title must be provided in English language. If original title of the resource is non-English, please provide both titles: an original title and its English translation. | 1 | 0 | ResearchStudy.title | 0..1 | string | -9 | -9 | 0 | Questionnaire.title | 0..1 | string | -9 | -9 | 0 | Extension[document_title].valueString | 0..1 | string | -9 | -9 | 1 |
| ResourceTitle | title_language | Mandatory | Drop-down | EN (English), DE (German), ES (Spanish), FR (French) | The language of the title. | 1 | 0 | ResearchStudy.title.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | Questionnaire.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 | DocumentReference.description.extension[Translation].valueString | Tranlation 0..* ; Lang 1..1 / Content 1..1 | code / string, markdown | -9 / -9 | -9 / -9 | 1 |
| ResourceAcronym | acronym | Recommended | Text | - | If existing, the acronym of the resource. | 1 | 0 | ResearchStudy.extension[Acronym].valueString | 0..1 | string | -9 | -9 | 1 | Questionnaire.extension[Acronym].valueString | 0..1 | string | -9 | -9 | 1 | DocumentReference.extension[Acronym].valueString | 0..1 | string | -9 | -9 | 1 |
| ID | ID | Recommended | Text | - | Any identifiers (IDs) associated with the resource. This can be an identifier or identifiers of the related resource(s), contributor(s), institution(s), or an alternate identifier of the given resource provided by another registering system. | 1 | 0 | ResearchStudy.Identifier with related Types, System, Assigner, etc | 0..* | identifier | -9 | -9 | 0 | Questionnaire.Identifier | 0..* | identifier | -9 | -9 | 0 | DocumentReference.Identifier DocumentReference.related | 0..* / 0..* | identifier / Reference | -9 / any | -9 / -9 | 0 |
| ID | ID_type | Recommended | Drop-down | arXiv, bibcode, DOI, EAN13, EISSN, ISBN, ISSN, ISTC, LISSN, LSID, PMID, PURL, URL, URN, w3id, ORCID, ISNI, ROR, GRID, DRKS, ISRCTN, EudraCT, NCT (clinicaltrials.gov), Other | The type of the ID. Four main groups of ID types are: (*) IDs usually applied to documents and publications; (**) IDs applied to persons or institutions; (***) IDs applied to clinical trials registered in clinical trials register(s); (****) any other related identifiers (e.g., grant number). Controlled List Values: (*) arXiv, bibcode, DOI, EAN13, EISSN, ISBN, ISSN, ISTC, LISSN, LSID, PMID, PURL, URL, URN; (**) ORCID, ISNI, ROR, GRID; (***) DRKS, UTN, ISRCTN, EudraCT, EUDAMED, NCT (clinicaltrials.gov); (****) Other | 1 | 0 | ResearchStudy.identifier.type | 0..1 | CodeableConcept | IdentifierType | Extensible | 0 | Questionnaire.identifier.type | 0..1 | CodeableConcept | IdentifierType | Extensible | 0 | DocumentReference.identifier.type | 0..1 | CodeableConcept | IdentifierType | Extensible | 0 |
| ID | ID_date | Recommended | Date | - | If known, the date when the ID was assigned. Please, enter the date in the following format: DD.MM.YYYY. | 1 | 0 | ResearchStudy.identifier.period | 0..1 | Period | dateTime | Required | 0 | Questionnaire.identifier.period | 0..1 | Period | dateTime | Required | 0 | DocumentReference.identifier.period | 0..1 | Period | dateTime | Required | 0 |
| ID | RelationType | Recommended | Drop-down | IsCitedBy, Cites IsSupplementTo, IsSupplementedBy IsContinuedBy, Continues IsDescribedBy, Describes HasMetadata, IsMetadataFor HasVersion, IsVersionOf IsNewVersionOf, IsPreviousVersionOf IsPartOf, HasPart IsReferencedBy, References IsDocumentedBy, Documents IsCompiledBy, Compiles IsVariantFormOf, IsOriginalFormOf IsIdenticalTo IsReviewedBy, Reviews IsDerivedFrom, IsSourceOf IsRequiredBy, Requires IsObsoletedBy, Obsoletes | Description of the relationship of the given resource and an related resource, person, or institution. Alternate identifiers can be also included. For definitions, examples and usage notes, see the latest version of the DataCite Metadata Schema at https://schema.datacite.org/. | 1 | 0 | ResearchStudy.extension[Relation_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.extension[Relation_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.extension[Relation_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 |
| Roles | role_type | Mandatory | Drop-down | Contributor, ContactPerson, DataCollector, DataCurator, DataManager, Distributor, Editor, HostingInstitution, Producer, ProjectLeader, ProjectManager, ProjectMember, RegistrationAgency, RegistrationAuthority, RelatedPerson, Researcher, ResearchGroup, RightsHolder, Supervisor, WorkPackageLeader, Sponsor, Sponsor-Investigator, Funder, Publisher, Other | The type of the role, i.e. the type of the resource contributor. For each resource, there may be multiple contributors, but at least one contributor must be specified. For definitions, see the latest version of the DataCite Metadata Schema at https://schema.datacite.org/. Please note that the following terms have the meanings which can be different from DataCite definitions: “Sponsor” is an organization or person who takes responsibility for and initiates a study. “Sponsor-Investigator” is the person who both initiates and conducts the study. “Funder” is an organization or person providing financial support for a study. “ProjectLeader” is equivalent to the Principal Investigator of a study, i.e. the person who both initiates and conducts the study . | 1 | 0 | ResearchStudy.Contact.ContactDetail.extension[Role_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.Contact.ContactDetail.extension[Role_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.author.extension[Role_type].valueCodeableConcept / DocumentReference.authenticator.extension[Role_type] / DocumentReference.custodian.extension[Role_type] or set by default when selecting one of these items | 0..1 | CodeableConcept | -9 | -9 | 1 |
| Roles | role_name | Mandatory | Text | - | Name associated with the role. This may be a personal or an institutional name. For the personal name, format should be: family name, given name. | 1 | 0 | ResearchStudy.Contact.ContactDetail.name | 0..1 | string | -9 | -9 | 0 | Questionnaire.Contact.ContactDetail.name | 0..1 | string | -9 | -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with name in related Reference (Practioner, PractitionerRole, Organization) | 0..1 | string | -9 | -9 | 0 |
| Roles | role_email | Recommended | Text | - | If applicable, the email address associated with a role. | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_phone | Recommended | Text | - | If applicable, the phone number associated with a role. Please, use the International ITU-T E.164-number structure for geographic areas. Example: +49 (0)153 1112233. | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_web_page | Recommended | Text | - | If applicable, the web-page associated with a role. | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_address | Recommended | Text | - | If applicable, the address associated with a role. The address should include the institution/affiliation name and the elements of a postal address, i.e. street, house number, city, postal code, (if applicable) state/province, and country. | 1 | 0 | ResearchStudy.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | Questionnaire.Contact.ContactDetail.telecom | 0..* | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 | DocumentReference.author / DocumentReference.authenticator / DocumentReference.custodian with telecom in related Reference (Practioner, PractitionerRole, Organization) | 0..* / 0..1 / 0..1 | ContactPoint -> ContactPoint.system (code, 0..1) + ContactPoint.value (string, 0..1) | ContactPointSystem: phone, fax, email, pager, url, sms, other / -9 | Required / -9 | 0 |
| Roles | role_specific_type | Recommended | Drop-down | Sponsor: primary, secondary Funder: public/private | The classification of the role types “Sponsor” and “Funder” into a predefined list of specific role types. | 1 | 0 | ResearchStudy.Contact.ContactDetail.extension[Role_specific_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | Questionnaire.Contact.ContactDetail.extension[Role_specific_type].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | DocumentReference.author.extension[Role_specific_type].valueCodeableConcept / DocumentReference.authenticator.extension[Role_specific_type] / DocumentReference.custodian.extension[Role_specific_type] | 0..1 | CodeableConcept | -9 | -9 | 1 |
| StudyDesign | study_primary_design | Mandatory | Drop-down | Interventional Non-interventional | The primary design of a study. Select between non-interventionl and interventional study design. An interventional study refers to a study that aims to alter study outcomes of interest. A non-interventional study refers to a study that does not aim to alter study outcomes of interest. | 0 | 1 | ResearchStudy.category | 0..* | CodeableConcept | ResearchStudyFocus | -8 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_type | Mandatory | Drop-down | Interventional study models: Single Group, Parallel, Crossover, Factorial, Sequential, Other Non-interventionl study models: Cohort, Case-Control, Case-Only, Case-Crossover, Cross-Sectional, Ecologic or Community Studies, Family-Based, Other | In case of an interventional study, the strategy for assigning interventions to participants. In case of a non-interventional study, the primary strategy for participant identification and follow-up. | 0 | 1 | ResearchStudy.category | 0..* | CodeableConcept | ResearchStudyFocus | -8 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_hypothesis | Recommended | Text | - | A statement of the hypotheses underlying the study. | 0 | 1 | ResearchStudy.objective.name, ResearchStudy.objective.type | 0..1 / 0..1 | string / CodeableConcept | -9 / ResearchStudyObjectiveType | -9 / Preferred | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_analysis_unit | Recommended | Drop-down | Individual, Organization, Family, Household, Event/Process, Geographic Unit, Time Unit, Text Unit, Group, Object, Pathogens, Twins, Other | The primary unit of operational and/or administrative interest in a study. For definitions, see the DDI Controlled Vocabulary: https://ddialliance.org/Specification/DDI-CV/AnalysisUnit_1.0.0.html. | 0 | 1 | ResearchStudy.extension[Study_analysis_unit].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_status | Mandatory | Drop-down | Not yet recruiting, Recruiting, Enrolling by invitation, Active, not recruiting, Completed, Suspended, Terminated, Withdrawn | Overall recruitment status for the study. | 0 | 1 | ResearchStudy.status | 1..1 | code | ResearchStudyStatus: active, administratively-completed, approved, closed-to-accrual, closed-to-accrual-and-intervention, completed, disapproved, in-review, temporarily-closed-to-accrual, temporarily-closed-to-accrual-and-intervention, withdrawn | Required | 2 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_eligibility | Mandatory | Text | - | Eligibility criteria for the study, if possible organized by inclusion and exclusion criteria. | 0 | 1 | ResearchStudy.enrollment.extension[Study_eligibility].valueString | 0..1 | string | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_sampling | Recommended | Drop-down | TotalUniverseCompleteEnumeration, Probability, Probability.SimpleRandom, Probability.SystematicRandom, Probability.Stratified, Probability.Stratified.Proportional, Probability.Stratified.Disproportional, Probability.Cluster, Probability.Cluster.SimpleRandom, Probability.Cluster.StratifiedRandom, Probability.Multistage, Nonprobability, Nonprobability.Availability, Nonprobability.Purposive, Nonprobability.Quota, Nonprobability.RespondentAssisted, MixedProbabilityNonprobability, Other | Applied sampling method. For definitions, see DDI Controlled Vocabulary: https://ddialliance.org/Specification/DDI-CV/SamplingProcedure_1.1.html. | 0 | 1 | ResearchStudy.extension[Study_sampling].valueCodeableConcept or ResearchStudy.enrollment.extension[Study_sampling].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_country | Mandatory | Multiselect | Country names from the ISO 3166-1 list | Country or countries in which a study takes place. | 0 | 1 | ResearchStudy.location | 0..* | CodeableConcept | Jurisdiction | Extensible | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_region | Recommended | Text | - | If applicable, region(s) and/or cities within a country, in which a study takes place. | 0 | 1 | ResearchStudy.location | 0..* | CodeableConcept | Jurisdiction | Extensible | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_conditions | Recommended | Text | - | Primary health condition(s) or problem(s) studied. | 0 | 1 | ResearchStudy.condition | 0..* | CodeableConcept | Condition/Problem/Diagnosis Codes | Example | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_population | Mandatory | Text | - | Detailed description of the study population. Any information important for the given study can be specified here. | 0 | 1 | ResearchStudy.extension[General_description_study_population].valueString or ResearchStudy.enrollment.extension[General_description_study_population].valueString | 0..1 | String | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_target_sample_size | Recommended | Integer | - | Intended number of observational units of a study (e.g., intended number of study participants). | 0 | 1 | ResearchStudy.enrollment.extension[Study_target_sample_size].valueUnsignedInt | 0..* | unsignedInt | -9 | Any non-negative integer in the range 0..2,147,483,647 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_obtained_sample_size | Recommended | Integer | - | Obtained number of observational units of a study (e.g., obtained number of study participants). The values are only available after end of recruitment. | 0 | 1 | ResearchStudy.Enrollment: Reference(Group) -> Group.quantity | 0..* | unsignedInt | -9 | Any non-negative integer in the range 0..2,147,483,647 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_age_min | Recommended | Float | - | Minimum age of participants for inclusion provided in years. | 0 | 1 | ResearchStudy.Enrollment: Reference(Group) -> Group.characteristic.code (CodeableConcept)+ Group.characteristic.value.Quantity (Quantity) + Group.characteristic.value.Exclude (boolean) | 0..* | CodeableConcept / Quantity / boolean | -9 / decimal / boolean | -9 / decimal / includes or excludes | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_age_max | Recommended | Float | - | Maximum age of participants for inclusion provided in years. | 0 | 1 | ResearchStudy.Enrollment: Reference(Group) -> Group.characteristic.code (CodeableConcept)+ Group.characteristic.value.Quantity (Quantity) + Group.characteristic.value.Exclude (boolean) | 0..* | CodeableConcept / Quantity / boolean | -9 / decimal / boolean | -9 / decimal / includes or excludes | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_start_date | Recommended | Date | - | Start date of data collection for the study. In case of a planned study, it is the intended start date; in case of an ongoing study — the actual start date. Please enter the date in the following format: DD.MM.YYYY. | 0 | 1 | ResearchStudy.period | 0..1 | Period | dateTime | Starting time with inclusive boundary | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_end_date | Recommended | Date | - | End date of data collection for the study. In case of a planned or ongoing study, it is the intended end date; in case of a completed study — the actual end date. | 0 | 1 | ResearchStudy.period | 0..1 | Period | dateTime | End time with inclusive boundary, if not ongoing | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_datasource | Recommended | Multiselect | Questionnaires, Physical measures, Blood, Urine, Saliva, Cord blood, Tissues, Buccal cells, Hair, Nail, Cognitive measures, Imaging, Administrative databases, Other | Sources from which the data are generated or extracted. | 0 | 1 | ResearchStudy.extension[Study_data_source].valueCodeableConcept | 0..1 | CodeableConcept | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| StudyDesign | study_design_comment | Recommended | Text | - | Any information on the specific study design aspects that cannot be captured by other fields. | 0 | 1 | ResearchStudy.note | 0..* | Annotation | -9 | -9 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| InterventionalStudyDesign | study_interventions | Mandatory | Text | - | Specification of the intervention(s) associated with each arm or group; at least one intervention must be specified. If possible, please indicate the type and the name of intervention(s). For definition of intervention types, see the ClinicalTrials.gov Protocol Registration Data Element Definitions at https://prsinfo.clinicaltrials.gov/definitions.html (Section “8. Arms, Groups, and Interventions” -> “Interventions” -> “Intervention Type”) | 0 | 1 | ResearchStudy.arm.name, ResearchStudy.arm.type, ResearchStudy.arm.descriptions | 1..1 / 0..1 / 0..1 | string / CodeableConcept / String | -9 / -9 / -9 | -9 / -9 / -9 | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| InterventionalStudyDesign | study_primary_outcomes | Mandatory | Text | - | Description of each primary outcome measure. If possible, arrange the information as follows: Title, Description, Time Frame. | 0 | 1 | ResearchStudy.extension[Outcome].valueString + ResearchStudy.extension[Primary_outcome] | 0..1 | string | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| InterventionalStudyDesign | study_secondary_outcomes | Recommended | Text | - | Description of each secondary outcome measure. If possible, arrange the information as follows: Title, Description, Time Frame. | 0 | 1 | ResearchStudy.extension[Outcome].valueString + ResearchStudy.extension[Secondary_outcome] | 0..1 | string | -9 | -9 | 1 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| InterventionalStudyDesign | study_phase | Recommended | Drop-down | Preclinical, early-phase-1,phase-1, phase-1-phase-2, phase-2, phase-2-phase-3, phase-3, phase-4, N/A, Other | If applicable, numerical phase of a study. For definitions, see the ClinicalTrials.gov Protocol Registration Data Element Definitions at https://prsinfo.clinicaltrials.gov/definitions.html (Section “7. Study Design” -> “Study Phase”). | 0 | 1 | ResearchStudy.phase | 0..1 | CodeableConcept | ResearchStudyPhase | Example | 0 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 | -7 |
| DocumentReference.status | 1..1 | code | DocumentReferenceStatus: current, superseded, entered-in-error | Required | x | ||||||||||||||||||||
| Questionnaire.status | 1..1 | code | PublicationStatus: draft, active, retired, unknown | Required | x | ||||||||||||||||||||
| Group.type | 1..1 | Code | GroupType: person, animal, practitioner, device, medication,substance | Required | x | ||||||||||||||||||||
| Group.actual | 1..1 | boolean | Descriptive or actual | Descriptive or actual | x | ||||||||||||||||||||
A
B
C
D
E
F
G
H
I
J
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
| Binary System to classify into general items and study specific items | |||||||||
| Category | Description | ||||||||
| 0 | FALSE | ||||||||
| 1 | TRUE | ||||||||
| Mapping_high_level | |||||||||
| Category | Description | ||||||||
| 0 | Available as standard resource | ||||||||
| 1 | Available as extension | ||||||||
| 2 | Mapping to FHIR not possible | ||||||||
| x | To be added to the MDS | ||||||||
| -7 | Item not applicable for this resource type | ||||||||
| The value "-9" has been used in the mapping table to describe, that there were no known constraints for element types or value sets. | |||||||||
