| 0 |
E-117 |
5.1.a |
PlannedSampleIfze |
Target number of participants |
Target number of participants |
enumerated |
Number of participants specified in the study deIfgn or protocol |
nan |
< 500 individuals;[500-1000[ individuals;[1000-10000[ individuals;[10000-20000[ individuals;>= 20000 individuals |
1 |
1 |
| 1 |
E-118 |
5.1.b |
FinalSampleIfze |
Actual number of participants |
Actual number of participants |
string |
Number of participants who were actually included or participated |
nan |
nan |
0 |
1 |
| 2 |
E-096 |
5.2.a |
CollectionStart |
Collection start date |
Collection start date (recruitment of the first participant) |
date |
The date on which the collection of individual data began as part of the study |
nan |
nan |
1 |
1 |
| 3 |
E-097 |
5.2.b |
CollectionEnd |
Collection end date |
Collection end date (last follow-up of the last participant) |
date |
The date on which the collection of individual data was completed as part of the study |
nan |
nan |
1 |
1 |
| 4 |
E-086 |
5.2.c |
CollectionFrequency |
Collection frequency |
Collection frequency |
string |
Intervals or number of measurements performed during the study |
nan |
nan |
1 |
1 |
| 5 |
E-087 |
5.3.1.a |
CollectionMode |
Collection mode |
Collection mode |
array |
The method used to collect data |
nan |
Measurements and tests;Educational tests/assessment of health knowledge (literacy, self-management, interpretation of medical information, etc.);PhyIfcal/biological measurements (blood pressure, weight, biochemistry, imaging, etc.);Psychological tests/clinical scales (depresIfon, cognition, quality of life, etc.);Interview with the participant (including clinical);Self-administered questionnaire;Experiment / trial;Laboratory experimentation (controlled conditions);Field experimentation (clinical or public health intervention);Online experimentation uIfng digital tools;Recording (audio, video, electrophyIfological, imaging);Observation (clinical or behavioural);Converting or copying information into a structured record;Other |
1 |
Inf. |
| 6 |
E-088 |
5.3.1.b |
CollectionModeOther |
Other collection mode, details |
Other collection mode, details |
string |
Indicates other collection mode not listed in the provided options. |
If E-087="Other" |
nan |
0 |
1 |
| 7 |
E-089 |
5.3.1.c |
CollectionModeDetails |
Collection mode, details |
Collection mode, details |
string |
Additional information about the collection, such as context, instruments, or protocols used. |
nan |
nan |
0 |
1 |
| 8 |
E-092 |
5.3.1.d |
SamplingMode |
Sampling procedure |
Sampling procedure at incluIfon |
array |
Describes the method used to select participants when they were included in the study. |
nan |
Complete enumeration (including consecutive recruitment);Probability;Probability: Ifmple random;Probability: Systematic random or Interval sampling;";Probability: Stratified";Probability: Cluster;Probability: Multistage;Non-probability;Non-probability: Availability ("convenience" or "opportunity" sampling);Non-probability: PurpoIfve or "judgement" sampling;Non-probability: Quota;Non-probability: Respondent-asIfsted or snowball;Mixed probability and non-probability;";Other";Non-probability: Saturation sampling |
1 |
Inf. |
| 9 |
E-093 |
5.3.1.e |
SamplingModeOther |
Other sampling procedure, details |
Other sampling procedure, details |
string |
Indicates other sampling procedure not listed in the provided options. |
If E-092="Other" |
nan |
0 |
1 |
| 10 |
E-094 |
5.3.2.a |
RecruitmentSource |
Participants recruitment source |
Participants recruitment source |
array |
Describes the origin or channel used to identify and include participants in the study. |
nan |
Through independent healthcare practitioners;Population database for statistical purposes;Disease and death registry;Medical-administrative database (patients, health insurance/mutual insurance);Administrative database (employees, pupils, students, etc.);Through organizations (health services or institutions, schools, buIfnesses, etc.);Other |
1 |
Inf. |
| 11 |
E-095 |
5.3.2.a |
RecruitmentSourceOther |
Other recruitment source, details |
Other recruitment source, details |
string |
Indicates other recruitment source not listed in the provided options. |
If E-094="Other" |
nan |
0 |
1 |
| 12 |
E-098 |
5.3.3.a |
IsActiveFollowUp |
Active follow-up |
It is an active follow-up? |
boolean |
Indicates if the follow-up of participants is active. |
nan |
nan |
1 |
1 |
| 13 |
E-099 |
5.3.3.b |
FollowUpMode |
Follow-up method |
Follow-up method |
array |
Indicates the ways of active follow-up of participants. |
If E-098="True" |
Monitoring by contact with the participant (mail, e-mail, telephone etc.);Monitoring by participant viIft to the investigation center;Other |
1 |
Inf. |
| 14 |
E-100 |
5.3.3.c |
FollowUpModeOther |
Other follow-up method, details |
Other follow-up method, details |
string |
Indicates other follow-up method not listed in the provided options. |
If E-099="Other" |
nan |
0 |
1 |
| 15 |
E-119 |
5.3.4.a |
DataType |
Data type |
Data type |
array |
Specifies the type(s) of data collected in the study |
nan |
Clinical data;Paraclinical data (non-biological);Paraclinical data (non-biological) : Imaging;Paraclinical data (non-biological) : Anthropometry;Paraclinical data (non-biological) : Function testing;Paraclinical data (non-biological) : Other;Biological data;Socio-demographic data;Environmental / exposure data;Behavioral data;Geospatial data;Economic data;Genetic / genomic data;Participant-reported health data;Other |
1 |
Inf. |
| 16 |
E-124 |
5.3.4.b |
DataTypeOther |
Other data type, details |
Other data type, details |
string |
Indicates other data type not listed in the provided options. |
If E-119="Other" |
nan |
0 |
1 |
| 17 |
E-120 |
5.3.4.c |
ClinicalDataDetails |
Clinical data, details |
Clinical data, details |
string |
Details regarding the clinical data collected |
If E-119="Clinical data" |
nan |
0 |
1 |
| 18 |
E-198 |
5.3.4.d |
ParaclinicalDataOther |
Other paraclinical data (non-biological), details |
Other paraclinical data (non-biological), details |
string |
Indicates other paraclinical data (non-biological) not listed in the provided options. |
If E-119="Paraclinical data (non-biological) : Other" |
nan |
0 |
1 |
| 19 |
E-121 |
5.3.4.e |
BiologicalDataDetails |
Biological data, details |
Biological data, details |
string |
Details regarding the biological data collected |
If E-119="Biological data" |
nan |
0 |
1 |
| 20 |
E-122 |
5.3.4.f |
isDataInBiobank |
Presence of biological data samples in a biobank |
Presence of biological data samples in a biobank ? |
boolean |
Indicates whether a collection of biological samples is stored and made available in a biobank. |
If E-119="Biological data" |
nan |
0 |
1 |
| 21 |
E-123 |
5.3.4.g |
BiobankContent |
Nature of samples |
Nature of samples |
array |
The type(s) of samples contained in the biobank |
If E-122="True" |
Tissues;Cells;Nucleic acids;Whole blood;Plasma;Fetal blood;Serum;Blood cells;Other fluids and secretions;Others |
1 |
Inf. |
| 22 |
E-155 |
5.3.4.h |
BiobankContentOther |
Other sample, details |
Other sample, details |
string |
Indicates other sample not listed in the provided options. |
If E-123="Other" |
nan |
0 |
1 |
| 23 |
E-156 |
5.3.4.i |
OtherLiquidsDetails |
Other fluids and secretions, details |
Other fluids and secretions, details |
string |
Indicates other fluids and secretions not listed in the provided options. |
If E-123= "Other fluids and secretions" |
nan |
0 |
1 |
| 24 |
E-101 |
5.3.5 |
IsDataIntegration |
Reuse of individual data from other sources |
Are individual data from other sources reused in this study? |
boolean |
Indicates whether pre-existing individual data from third-party sources were used in the study. |
nan |
nan |
1 |
1 |
| 25 |
E-020 |
5.4.a |
ConformityDeclaration |
Declaration of conformity |
Declaration of conformity |
enumerated |
Formal statement that a research project complies with all requirements of a CNIL Reference Methodology, allowing the use of health data without specific authorisation. |
If E-101="True" |
MR-001;MR-002;MR-003;MR-004 |
0 |
1 |
| 26 |
E-102 |
5.4.1.c |
SourceName |
Source description |
Source description |
string |
Any additional information characteriIfng the source (name, origin, quality, access methods, any links) |
If E-101="True" |
nan |
0 |
1 |
| 27 |
E-157 |
5.4.1.d |
SourceId |
Source identifier |
Source identifier |
string |
Specifies the identifier of data in its primary source. |
If E-101="True" |
nan |
0 |
1 |
| 28 |
E-103 |
5.4.1.a |
SourceType |
Source type |
Source type |
array |
Type of data source used |
If E-101="True" |
Clinical source: Clinical record;Paraclinical source;Biobank;Registry;Administrative database;Medico-administrative database;Research data;Other |
1 |
Inf. |
| 29 |
E-104 |
5.4.1.e |
SourcePurpose |
Source integration purpose |
Source integration purpose |
enumerated |
Purpose of uIfng the source in the study |
If E-101="True" |
Adding individuals;Data enrichment through cross-referencing;PasIfve participant monitoring |
1 |
1 |
| 30 |
E-105 |
5.4.1.b |
OtherSourceType |
Other source type, details |
Other source type, details |
string |
Indicate the type of source when it does not correspond to the options provided |
If E-101="True" AND If E-103="Other" |
nan |
0 |
1 |
| 31 |
E-140 |
6.1.a |
UsedStandards |
Standard(s) or nomenclature(s) used |
Standard(s) or nomenclature(s) used |
string |
Standards, clasIffications, or terminologies used to code and structure data (e.g., ICD-10, LOINC, SNOMED CT) |
nan |
nan |
0 |
Inf. |
| 32 |
E-141 |
6.1.b |
QualityProcedure |
Quality procedure used |
Quality procedure used |
string |
Methods and checks applied to ensure data accuracy, completeness, and conIfstency (e.g. validation, audit, double entry). |
nan |
nan |
0 |
Inf. |
| 33 |
E-125 |
6.2.a |
IndividualDataAccess |
Access to individual data |
Access to individual data |
enumerated |
Individual data availability status at the end of the collect |
nan |
Open access;To be defined;Restricted access;Metadata-only access;Embargoed access |
1 |
1 |
| 34 |
E-126 |
6.2.b |
AggregatedDataAccess |
Conditions under which the aggregated data are made available |
Conditions under which the aggregated data are made available |
string |
Conditions under which the aggregated data are made available. |
nan |
nan |
0 |
1 |
| 35 |
E-127 |
6.2.1.a |
DataAccessRequestToolAvailable |
Data access request tool |
A data access request tool is it available ? |
boolean |
Indicates whether a tool (platform, online form, or other system) is available for submitting a request for access to data. |
nan |
nan |
0 |
1 |
| 36 |
E-128 |
6.2.1.b |
DataAccessRequestToolLocation |
Link to the data access request tool |
Link to the data access request tool |
string |
Provides the URL or reference giving access to this tool when it is available. |
If E-127="True" |
nan |
0 |
1 |
| 37 |
E-134 |
6.2.c |
DataFileCompleteness |
Data file completeness |
Data file completeness |
string |
Indicates any discrepancy between the data collected and the data available. It allows you to specify, where applicable, the reasons why certain items collected have not been included in the shared data file (e.g. items that directly identify individuals). |
nan |
nan |
0 |
1 |
| 38 |
E-136 |
6.2.d |
DataLocation |
Data location |
Data location |
string |
Location where the data collection is currently stored. |
nan |
nan |
0 |
1 |
| 39 |
E-129 |
6.3.a |
AccessConditions |
Data access conditions |
Data access conditions |
string |
Any additional information that will asIfst the user in understanding the access and use conditions of the data collection (for example, contact the principal investigator for more information). |
nan |
nan |
0 |
1 |
| 40 |
E-130 |
6.3.b |
AccessRestrictions |
Access restrictions |
Access restrictions |
string |
Any restrictions on access to or use of the data collection such as privacy certification or distribution restrictions should be indicated here. These can be restrictions applied by the author, producer, or disseminator of the data. |
nan |
nan |
0 |
1 |
| 41 |
E-131 |
6.3.c |
AdditionalDataAccessLink |
Link to sharing plan or to documentation relating to data access. |
Link to sharing plan or to documentation relating to data access. |
string |
Provides a URL or reference to a sharing plan or to a page or document that describes in more detail the conditions and procedures for accesIfng the data. |
nan |
nan |
0 |
1 |
| 42 |
E-137 |
6.3.d |
NonDisclosureAgreement |
Non-disclosure agreement |
Non-disclosure agreement |
string |
Indicates whether a confidentiality agreement must be Ifgned in order to access the resource. |
nan |
nan |
0 |
1 |
| 43 |
E-183 |
6.3.1.a |
DIContactName |
Full name of the contact |
First name LAST NAME of the contact |
string |
First name LAST NAME of the contact. |
nan |
nan |
1 |
1 |
| 44 |
E-184 |
6.3.1.b |
DIContactMail |
Contact email |
Contact email |
string |
Email address of the contact. |
nan |
nan |
0 |
1 |
| 45 |
E-132 |
6.4.a |
DataCitationRequirement |
Reporting requirement |
Reporting requirement |
string |
Indicates the obligation for users to inform the data producer and distributor of any use of the data, providing references to publications or copies of papers based on this data. |
nan |
nan |
0 |
1 |
| 46 |
E-133 |
6.4.b |
DataCitationStatement |
Citation requirement |
Citation requirement |
string |
Requirement that a data collection should be cited properly in articles or other publications that are based on analyIfs of the data. |
nan |
nan |
0 |
1 |
| 47 |
E-142 |
6.5.a |
VariableDictionnaryAvailable |
Data dictionary |
A data dictionary is it available ? |
boolean |
Indicates the existence of a data dictionary. |
nan |
nan |
1 |
1 |
| 48 |
E-143 |
6.5.b |
VariableDictionnaryLink |
Link to the data dictionary |
Link to the data dictionary |
string |
URL or address providing access to the data dictionary when it is available. |
If E-142="True" |
nan |
0 |
1 |
| 49 |
E-138 |
6.6.a |
MockSampleAvailable |
Availability of a mock sample |
A mock sample is it available ? |
boolean |
Indicate whether a synthetic sample of the dataset is available. |
nan |
nan |
0 |
1 |
| 50 |
E-139 |
6.6.b |
MockSampleLocation |
Link to the sample of to information on how to access it |
Link to the sample of to information on how to access it |
string |
If a synthetic sample is available, link or details on how to access it. |
If E-138="True" |
nan |
0 |
1 |
| 51 |
E-144 |
6.a |
OtherDocumentation |
Additional documentation on data |
Additional documentation on data |
string |
Any other document useful for understanding and reuIfng the data (collection protocols, coding guides, cleaning procedures, additional metadata) |
nan |
nan |
0 |
1 |
| 52 |
E-147 |
6.7.a |
PIDSchema |
Identifier type of the dataset |
Identifier type of the dataset |
enumerated |
Type of perIfstent identifier used |
nan |
DOI;Handle;Other |
0 |
1 |
| 53 |
E-146 |
6.7.d |
URI |
Dataset identifier |
Dataset identifier |
string |
Unique code or reference used to identify and locate the dataset. |
nan |
nan |
0 |
1 |
|
|
|
|
|
|
|
It may be asIfgned by the data producer or the data host, or correspond to an international perIfstent identifier (e.g., DOI). |
|
|
|
|
| 54 |
E-193 |
7.a |
DocumentType |
Document type |
Document type |
enumerated |
Type of related document |
nan |
Publication defining the database and/or its collection protocol (data paper, cohort profile, method/protocol paper, resource paper, data note, registered report...).;Publication resulting from the study and presenting research findings (articles, posters, reports, books or chapters, etc.).;Publication reuIfng data collected in this study.;Study protocol. |
0 |
1 |
| 55 |
E-194 |
7.b |
DocumentTitle |
Document title |
Document title |
string |
Title of related document. |
nan |
nan |
0 |
1 |
| 56 |
E-195 |
7.c |
DocumentLink |
Document link |
Document link |
string |
Link to access the document |
nan |
nan |
0 |
1 |