| Concept |
Card/Conf |
Id |
 |
Design |
|
0 … 1 Conditional |
|
|
Characteristics of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.classification.type == ("Study" OR "Substudy" OR "Registry" OR "Secondary
data source")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy" OR "Registry" OR "Secondary
data source")
|
|
|
 |
|
primaryDesign |
|
0 … 1 Conditional |
|
|
Is it an interventional or non-interventional [RESOURCE]?
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
 |
 |
studyType |
|
0 … 1 Conditional |
|
|
Specification of the type of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
0 … * Conditional |
|
|
Interventional [RESOURCE] type
|
|
| Card/Conf |
Condition |
| 1 … * Mandatory |
1..*, if Design.primaryDesign == "Interventional" |
| 0 … 0 Not permitted |
0..0, if Design.primaryDesign != "Interventional" |
|
|
|
|
0 … * Conditional |
|
|
Non-interventional [RESOURCE] type
|
|
| Card/Conf |
Condition |
| 1 … * Mandatory |
1..*, if Design.primaryDesign == "Non-interventional" |
| 0 … 0 Not permitted |
0..0, if Design.primaryDesign != "Non-interventional" |
|
|
 |
 |
conditions |
|
0 … * |
|
|
Primary health condition(s) or disease(s) considered in the [RESOURCE]
|
|
|
1 … 1 Mandatory |
|
|
Primary health condition or disease name
|
|
|
1 … 1 Mandatory |
|
|
Terminology/classification
|
|
|
0 … 1 |
|
|
Code of the health condition or disease
|
 |
 |
focus |
|
0 … * |
nfdhtfcov19-dataelement-132 link
|
|
Primary focus of the [RESOURCE]
|
|
|
1 … 1 Mandatory |
nfdhtfcov19-dataelement-133 link
|
|
Focus area
|
|
|
1 … 1 Mandatory |
nfdhtfcov19-dataelement-134 link
|
|
Terminology/classification
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-135 link
|
|
Code of the focus area
|
 |
 |
groupsOfDiseases |
|
1 … 1 Mandatory |
|
|
Groups of diseases or conditions
|
|
|
1 … * Mandatory |
|
|
Which groups of diseases or conditions were the data collected on?
|
|
|
0 … * |
|
|
On which diseases or conditions were the data collected?
|
 |
|
mortalityData |
|
0 … 1 Conditional |
|
|
Collects mortality data?
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.studyType.nonInterventional
== ("Longitudinal" OR "Cohort" OR "Case-cohort" OR "Birth cohort" OR "Trend" OR "Panel"))
OR Resource.classification.type == ("Registry" OR
"Secondary data source")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND
Design.studyType.nonInterventional != ("Longitudinal" OR "Cohort" OR "Case-cohort"
OR "Birth cohort" OR "Trend" OR "Panel")
|
|
|
 |
 |
administrativeInformation |
|
0 … 1 Conditional |
nfdhtfcov19-dataelement-136 link
|
|
Administrative information about the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 1 |
0..1, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
0 … 1 |
|
|
Status of the ethics committee approval
|
|
|
0 … 1 Conditional |
|
|
Overall [RESOURCE] status
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
0 … 1 Conditional |
|
|
Participants receive an intervention?
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Interventional" AND Design.administrativeInformation.status == ("At the planning
stage" OR "Ongoing (I): Recruitment ongoing, but data collection not yet
started" OR "Ongoing (II): Recruitment and data collection ongoing" OR "Ongoing (III):
Recruitment completed, but data collection ongoing" OR "Ongoing (IV): Recruitment
and data collection completed, but data quality management ongoing")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign
!= "Interventional" OR Design.administrativeInformation.status != ("At the planning
stage" OR "Ongoing (I): Recruitment ongoing, but data
collection not yet started" OR "Ongoing (II): Recruitment and data collection ongoing"
OR "Ongoing (III): Recruitment completed, but data collection ongoing" OR "Ongoing
(IV): Recruitment and data collection completed, but data quality management ongoing")
|
|
|
|
|
0 … 1 Conditional |
|
|
Stopping stage
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.administrativeInformation.status
== ("Suspended: Recruitment, data collection, or data quality management, halted,
but potentially will resume" OR "Terminated: Recruitment, data
collection, data and quality management halted prematurely and will not resume")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.administrativeInformation.status
!= ("Suspended: Recruitment, data collection, or data quality management, halted,
but potentially will resume" OR "Terminated:
Recruitment, data collection, data and quality management halted prematurely and will
not resume")
|
|
|
|
|
0 … 1 Conditional |
|
|
Stopping reason
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.administrativeInformation.status
== ("Suspended: Recruitment, data collection, or data quality management, halted,
but potentially will resume" OR "Terminated: Recruitment, data
collection, data and quality management halted prematurely and will not resume")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.administrativeInformation.status
!= ("Suspended: Recruitment, data collection, or data quality management, halted,
but potentially will resume" OR "Terminated:
Recruitment, data collection, data and quality management halted prematurely and will
not resume")
|
|
|
 |
 |
|
statusEnrollingByInvitation |
|
0 … 1 Conditional |
|
|
Participants enrolled by invitation?
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
 |
 |
|
recruitmentStatusRegister |
|
0 … 1 Conditional |
|
|
Overall recruitment status from the register of clinical trials
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Resource.provenance.dataSource
!= "Manually collected"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Resource.provenance.dataSource
== "Manually collected"
|
|
|
|
|
0 … 1 |
|
|
Start date
|
|
|
0 … 1 |
|
|
End date
|
 |
|
centers |
|
0 … 1 Conditional |
|
|
Mono- or multicentric?
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
 |
|
centersNumber |
|
0 … 1 Conditional |
|
|
Number of centers
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.centers
== "Multicentric"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.centers
!= "Multicentric"
|
|
|
 |
|
dataProviders |
|
0 … 1 Conditional |
nfdhtfcov19-dataelement-137 link
|
|
One or more data providers?
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Registry" OR "Secondary data source") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") |
|
|
 |
|
dataProvidersNumber |
|
0 … 1 Conditional |
nfdhtfcov19-dataelement-138 link
|
|
Number of data providers
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Registry" OR "Secondary data source") AND
Design.dataProviders == "Several data providers"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") OR
Design.dataProviders != "Several data providers"
|
|
|
 |
|
subject |
|
1 … 1 Mandatory |
|
|
Primary subject
|
 |
 |
sampling |
|
0 … 1 Conditional |
|
|
Sampling method
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
1 … 1 Mandatory |
|
|
Applied sampling method
|
|
|
0 … 1 Conditional |
|
|
Specific type of probability sampling
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Design.sampling.method == "Probability" |
| 0 … 0 Not permitted |
0..0, if Design.sampling.method != "Probability" |
|
|
|
|
0 … 1 Conditional |
|
|
Specific type of non-probability sampling
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Design.sampling.method == "Non-probability" |
| 0 … 0 Not permitted |
0..0, if Design.sampling.method != "Non-probability" |
|
|
 |
 |
dataSource |
|
0 … 1 |
|
|
Data sources of the [RESOURCE]
|
|
|
0 … * |
|
|
Type(s) of data sources
|
|
|
0 … * Conditional |
|
|
Biosamples collected
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Design.dataSource.general == "Biological samples" |
| 0 … 0 Not permitted |
0..0, if Design.dataSource.general != "Biological samples" |
|
|
|
|
0 … * Conditional |
|
|
Imaging data collected
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Design.dataSource.general == "Imaging data" |
| 0 … 0 Not permitted |
0..0, if Design.dataSource.general != "Imaging data" |
|
|
|
|
0 … * Conditional |
|
|
Omics technology used
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Design.dataSource.general == "Omics technology" |
| 0 … 0 Not permitted |
0..0, if Design.dataSource.general != "Omics technology" |
|
|
|
|
0 … 1 |
|
|
Additional information about data sources
|
 |
|
primaryPurpose |
|
0 … 1 Conditional |
|
|
Primary purpose of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
 |
 |
eligibilityCriteria |
|
0 … 1 |
|
|
Eligibility criteria for [RESOURCE] participants
|
|
|
0 … 1 |
|
|
Eligibility criteria: Minimum age
|
|
|
1 … 1 Mandatory |
|
|
Minimum eligible age
|
|
|
1 … 1 Mandatory |
|
|
Unit of age
|
|
|
0 … 1 |
|
|
Eligibility criteria: Maximum age
|
|
|
1 … 1 Mandatory |
|
|
Maximum eligible age
|
|
|
1 … 1 Mandatory |
|
|
Unit of age
|
|
|
0 … * |
|
|
Eligible gender
|
|
|
0 … 1 |
|
|
Inclusion criteria
|
|
|
0 … 1 |
|
|
Exclusion criteria
|
 |
 |
population |
|
1 … 1 Mandatory |
nfdhtfcov19-dataelement-139 link
|
|
Population of the [RESOURCE]
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-140 link
|
|
Coverage
|
|
|
1 … * Mandatory |
|
|
Country(ies)
|
|
|
0 … 1 |
|
|
Region(s) and/or city(ies)
|
|
|
0 … 1 |
|
|
Population description
|
|
|
0 … 1 Conditional |
|
|
Target sample size
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
0 … 1 |
|
|
Obtained sample size
|
 |
 |
ageMinExamined |
|
1 … 1 Required |
|
|
Actual minimum age of participants
|
|
|
1 … 1 Required |
|
|
Actual minimum age of participants
|
|
|
1 … 1 Required |
|
|
Unit of time
|
 |
 |
ageMaxExamined |
|
1 … 1 Required |
|
|
Actual maximum age of participants
|
|
|
1 … 1 Required |
|
|
Actual maximum age of participants
|
|
|
1 … 1 Required |
|
|
Unit of time
|
 |
|
hypothesis |
|
0 … * Conditional |
|
|
Research questions/hypotheses
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
 |
 |
arms |
|
0 … * Conditional |
|
|
Arms of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Interventional"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign
!= "Interventional"
|
|
|
|
|
1 … 1 Mandatory |
|
|
Name of the arm
|
|
|
1 … 1 Mandatory |
|
|
Role of the arm
|
|
|
0 … 1 |
|
|
Additional information about the arm
|
 |
 |
groups |
|
0 … * Conditional |
nfdhtfcov19-dataelement-141 link
|
|
Groups/cohorts of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Non-interventional"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign
!= "Non-interventional"
|
|
|
|
|
1 … 1 Mandatory |
nfdhtfcov19-dataelement-142 link
|
|
Name of the group
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-143 link
|
|
Additional information about the group
|
 |
 |
interventions |
|
0 … * Conditional |
|
|
Interventions of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Interventional"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign
!= "Interventional"
|
|
|
|
|
1 … 1 Mandatory |
|
|
Name of the intervention
|
|
|
0 … 1 |
|
|
Type of the intervention
|
|
|
0 … 1 |
|
|
Additional information about the intervention
|
|
|
0 … * |
|
|
Name(s) of the arm(s) associated with the given intervention
|
 |
 |
exposures |
|
0 … * Conditional |
nfdhtfcov19-dataelement-144 link
|
|
Exposures of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Non-interventional") OR Resource.classification.type == ("Registry" OR "Secondary
data source")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND
Design.primaryDesign != "Non-interventional"
|
|
|
|
|
0 … 1 Conditional |
nfdhtfcov19-dataelement-145 link
|
|
Name of the exposure
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-146 link
|
|
Type of the exposure
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-147 link
|
|
Additional information about the exposure
|
|
|
0 … * Conditional |
nfdhtfcov19-dataelement-148 link
|
|
Name(s) of the group(s) associated with the given exposure
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
 |
 |
outcomes |
|
0 … * |
|
|
Outcome measures in the [RESOURCE]
|
|
|
1 … 1 Mandatory |
|
|
Name of the outcome measure
|
|
|
0 … 1 |
|
|
Description of the outcome measure
|
|
|
0 … 1 Conditional |
|
|
Type of the outcome measure
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Design.outcomes.title != Null OR Design.outcomes.description != Null |
| 0 … 0 Not permitted |
0..0, if Design.outcomes.title == Null AND Design.outcomes.description == Null |
|
|
|
|
0 … 1 |
|
|
Time point(s) of assessment
|
 |
|
comment |
|
0 … 1 |
|
|
Additional information about the [RESOURCE]
|
 |
|
assessments |
|
0 … * |
|
|
Additional assessments/measurements in the [RESOURCE]
|
 |
 |
dataSharingPlan |
|
1 … 1 Mandatory |
|
|
Data sharing strategy of the [RESOURCE]
|
|
|
1 … 1 Mandatory |
|
|
Is it planned to share the data?
|
|
|
0 … * Conditional |
|
|
Supporting documents available in addition to the data
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Design.dataSharingPlan.generally == "Yes, there is a plan to make data available" |
| 0 … 0 Not permitted |
0..0, if Design.dataSharingPlan.generally != "Yes, there is a plan to make data available" |
|
|
|
|
0 … 1 Conditional |
|
|
When and for how long will the data be available?
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Design.dataSharingPlan.generally == "Yes, there is a plan to make data available" |
| 0 … 0 Not permitted |
0..0, if Design.dataSharingPlan.generally != "Yes, there is a plan to make data available" |
|
|
|
|
0 … 1 Conditional |
|
|
Criteria for data access
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Design.dataSharingPlan.generally == "Yes, there is a plan to make data available" |
| 0 … 0 Not permitted |
0..0, if Design.dataSharingPlan.generally != "Yes, there is a plan to make data available" |
|
|
|
|
0 … 1 |
|
|
Additional information about data sharing
|
|
|
0 … 1 |
|
|
DataSHIELD/Opal infrastructure available?
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-149 link
|
|
Link to data request application
|
|
|
0 … 1 |
|
|
Web page with additional information about data sharing
|
|
|
0 … 1 Conditional |
nfdhtfcov19-dataelement-150 link
|
|
Record linkage possible?
|
|
| Card/Conf |
Condition |
| 1 … 1 Mandatory |
1..1, if Resource.provenance.dataSource == "Manually collected" |
| 0 … 0 Not permitted |
0..0, if Resource.provenance.dataSource != "Manually collected" |
|
|
 |
 |
nonInterventional |
|
0 … 1 Conditional |
|
|
Non-interventional aspects of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if (Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
== "Non-interventional") OR Resource.classification.type == ("Registry" OR "Secondary
data source")
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Registry" OR "Secondary data source") AND
Design.primaryDesign != "Non-interventional"
|
|
|
|
|
0 … * Conditional |
|
|
Temporal design
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Resource.classification.type == ("Study" OR "Substudy") |
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") |
|
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-151 link
|
|
Target follow-up duration of the [RESOURCE]
|
|
|
1 … 1 Mandatory |
nfdhtfcov19-dataelement-152 link
|
|
Target follow-up duration
|
|
|
1 … 1 Mandatory |
nfdhtfcov19-dataelement-153 link
|
|
Unit of time
|
|
|
0 … 1 |
nfdhtfcov19-dataelement-154 link
|
|
Number of follow-ups conducted
|
|
|
1 … 1 Required |
|
|
Target follow-up duration
|
|
|
0 … * |
|
|
Biosamples retained in a biorepository
|
|
|
0 … 1 Conditional |
|
|
Specific types of retained biosamples
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Design.nonInterventional.biospecimenRetention != "None retained" |
| 0 … 0 Not permitted |
0..0, if Design.nonInterventional.biospecimenRetention == "None retained" |
|
|
 |
 |
interventional |
|
0 … 1 Conditional |
|
|
Interventional aspects of the [RESOURCE]
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Resource.classification.type == ("Study" OR "Substudy") AND Design.primaryDesign
=="Interventional"
|
| 0 … 0 Not permitted |
0..0, if Resource.classification.type != ("Study" OR "Substudy") OR Design.primaryDesign
!="Interventional"
|
|
|
|
|
0 … 1 |
|
|
Numerical phase
|
|
|
0 … 1 |
|
|
Masking of intervention(s) assignment
|
|
|
0 … 1 |
|
|
Masking implemented?
|
|
|
0 … * Conditional |
|
|
Who is masked?
|
|
| Card/Conf |
Condition |
| 0 … * |
0..*, if Design.interventional.masking.general == true |
| 0 … 0 Not permitted |
0..0, if Design.interventional.masking.general == false |
|
|
|
|
0 … 1 Conditional |
|
|
Additional information about masking
|
|
| Card/Conf |
Condition |
| 0 … 1 |
0..1, if Design.interventional.masking.general == true |
| 0 … 0 Not permitted |
0..0, if Design.interventional.masking.general == false |
|
|
|
|
0 … 1 |
|
|
Type of allocation of participants to an arm
|
|
|
0 … 1 |
|
|
Off-label use of a drug product
|
 |
Resource |
|
0 … * |
|
|
Resource
|
 |
 |
provenance |
|
1 … 1 Required |
|
|
Information about provenance aspects of the data entry
|
|
|
1 … 1 Required |
|
|
Source of information about the [RESOURCE]
|
|
|
1 … 1 Required |
|
|
Verfication date
|
|
|
1 … 1 Required |
|
|
User who last verified the [RESOURCE]
|
|
|
1 … 1 Required |
|
|
Date when the [RESOURCE] was first submitted for publication
|
|
|
1 … 1 Required |
|
|
User who first submitted the [RESOURCE] for publication
|
|
|
1 … 1 Required |
|
|
Date when the [RESOURCE] was first posted/published
|
|
|
1 … 1 Required |
|
|
User who first posted/published the [RESOURCE]
|
|
|
1 … 1 Required |
|
|
Date when the last update of the resource was submitted for publication. |
|
|
1 … 1 Required |
|
|
User who submitted the last update of the [RESOURCE]
|
|
|
1 … 1 Required |
|
|
Date when the last update of the [RESOURCE] was posted/published
|
|
|
1 … 1 Required |
|
|
User who posted/published the last update
|
|
|
1 … 1 Required |
|
|
Version number of the resource within the portal/system
|