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# Scenario Design3.3 2.16.840.1.113883.3.1937.777.64.3.4

Name | Details [‑]
--- | ---
Design3.3 nfdhtfcov19-scenario-4
Version / effective date | v3.3 - 2023‑12‑21
NFDI4Health Resource nfdhtfcov19-transaction-7link
Version / effective date | v3.3 - 2023‑12‑21 |  |
NFDI4Health Resource nfdhtfcov19-transaction-8link
Version / effective date | v3.3 - 2023‑12‑21 |  |
| Actor | Sender (person) Researcher
| Associations | Data Set (for transaction) Module Design (V3.3) v3.3(2.16.840.1.113883.3.1937.777.64.1.2 / 2023‑12‑04)
| Contained concepts
Concept | Card/Conf | Id
--- | --- | ---
| Design
| 0 … 1 Conditional | link
| 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 | link
| Is it an interventional or non-interventional [RESOURCE]? Short input help: Select between non-interventional and interventional design for the given [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 | link
| 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")
|  |  | interventional
| 0 … * Conditional | link
| Interventional [RESOURCE] type Short input help: Select all that apply.If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'.
Card/Conf | Condition
--- | ---
1 … * Mandatory | 1..*, if Design.primaryDesign == "Interventional"
0 … 0 Not permitted | 0..0, if Design.primaryDesign != "Interventional"
|  |  | nonInterventional
| 0 … * Conditional | link
| Non-interventional [RESOURCE] type Short input help: Select all that apply.If 'Other' is selected, please specify the type of the [RESOURCE] in the field 'Additional information about the [RESOURCE]'.
Card/Conf | Condition
--- | ---
1 … * Mandatory | 1..*, if Design.primaryDesign == "Non-interventional"
0 … 0 Not permitted | 0..0, if Design.primaryDesign != "Non-interventional"
|  | conditions
| 0 … * | link
| Primary health condition(s) or disease(s) considered in the [RESOURCE]
|  |  | label
| 1 … 1 Mandatory | link
| Primary health condition or disease name Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
|  |  | classification
| 1 … 1 Mandatory | link
| Terminology/classification Short input help: If used, name of the terminology/classification.
|  |  | code
| 0 … 1 | link
| Code of the health condition or disease Short input help: If known, you can provide the code from the terminology/classification used.
|  | focus
| 0 … * | nfdhtfcov19-dataelement-132link
| Primary focus of the [RESOURCE]
|  |  | label
| 1 … 1 Mandatory | nfdhtfcov19-dataelement-133link
| Focus area Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
|  |  | classification
| 1 … 1 Mandatory | nfdhtfcov19-dataelement-134link
| Terminology/classification Short input help: If used, name of the terminology/classification.
|  |  | code
| 0 … 1 | nfdhtfcov19-dataelement-135link
| Code of the focus area Short input help: If known, you can provide the code from the terminology/classification used.
|  | groupsOfDiseases
| 1 … 1 Mandatory | link
| Groups of diseases or conditions
|  |  | generally
| 1 … * Mandatory | link
| Which groups of diseases or conditions were the data collected on? Short input help: Select all that apply.For more information about the groups of diseases/conditions, visit the WHO's ICD-10 homepage: https://icd.who.int/en.
|  |  | conditions
| 0 … * | link
| On which diseases or conditions were the data collected? Short input help: Select all that apply.Values are based on lower level ICD-10. For more information visit the WHO's ICD-10 homepage: https://icd.who.int/en.
|  | mortalityData
| 0 … 1 Conditional | link
| 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-136link
| 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")
|  |  | ethicsCommiteeApproval
| 0 … 1 | link
| Status of the ethics committee approval
|  |  | status
| 0 … 1 Conditional | link
| Overall [RESOURCE] status Short input help: Select one value from the list.
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")
|  |  | statusWhenIntervention
| 0 … 1 Conditional | link
| Participants receive an intervention? Short input help: Select one value from the list.
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")
|  |  | stageStopped
| 0 … 1 Conditional | link
| Stopping stage Short input help: Select one value from the list.
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")
|  |  | reasonStopped
| 0 … 1 Conditional | link
| Stopping reason Short input help: You can provide reasons such as closed due to toxicity, closed due to lack of [RESOURCE] progress, temporarily-closed per [RESOURCE] design, etc.
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 | link
| 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 | link
| 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"
|  |  | startDate
| 0 … 1 | link
| Start date Short input help: In case of a planned [RESOURCE], enter the intended start date. In case of an ongoing [RESOURCE], enter the actual start date.
|  |  | endDate
| 0 … 1 | link
| End date Short input help: In case of a planned or ongoing [RESOURCE], enter the intended end date. In case of a completed [RESOURCE], enter the actual end date.
|  | centers
| 0 … 1 Conditional | link
| 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 | link
| 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-137link
| 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-138link
| 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 | link
| Primary subject Short input help: Select one value from the list.
|  | sampling
| 0 … 1 Conditional | link
| 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")
|  |  | method
| 1 … 1 Mandatory | link
| Applied sampling method Short input help: Select one value from the list.
|  |  | probabilityMethod
| 0 … 1 Conditional | link
| Specific type of probability sampling Short input help: If known, select one value from the list.
Card/Conf | Condition
--- | ---
0 … 1 | 0..1, if Design.sampling.method == "Probability"
0 … 0 Not permitted | 0..0, if Design.sampling.method != "Probability"
|  |  | nonProbabilityMethod
| 0 … 1 Conditional | link
| Specific type of non-probability sampling Short input help: If known, select one value from the list.
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 | link
| Data sources of the [RESOURCE]
|  |  | general
| 0 … * | link
| Type(s) of data sources Short input help: Select all that apply.
|  |  | biosamples
| 0 … * Conditional | link
| Biosamples collected Short input help: Select all that apply.
Card/Conf | Condition
--- | ---
0 … * | 0..*, if Design.dataSource.general == "Biological samples"
0 … 0 Not permitted | 0..0, if Design.dataSource.general != "Biological samples"
|  |  | imaging
| 0 … * Conditional | link
| Imaging data collected Short input help: Select all that apply.
Card/Conf | Condition
--- | ---
0 … * | 0..*, if Design.dataSource.general == "Imaging data"
0 … 0 Not permitted | 0..0, if Design.dataSource.general != "Imaging data"
|  |  | omics
| 0 … * Conditional | link
| Omics technology used Short input help: Select all that apply.
Card/Conf | Condition
--- | ---
0 … * | 0..*, if Design.dataSource.general == "Omics technology"
0 … 0 Not permitted | 0..0, if Design.dataSource.general != "Omics technology"
|  |  | description
| 0 … 1 | link
| Additional information about data sources Short input help: You can indicate here other data source(s) not listed in the field 'Type(s) of data sources' or provide a more detailed description of the selected data sources.
|  | primaryPurpose
| 0 … 1 Conditional | link
| Primary purpose of the [RESOURCE] Short input help: Foremost for interventional studies, please specify the primary purpose why the [RESOURCE] was conducted. For non-interventional studies, this field may be 'Not applicable' as multiple purposes may be defined as primary ones.
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 | link
| Eligibility criteria for [RESOURCE] participants
|  |  | ageMin
| 0 … 1 | link
| Eligibility criteria: Minimum age
|  |  |  | number
| 1 … 1 Mandatory | link
| Minimum eligible age Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.
|  |  |  | timeUnit
| 1 … 1 Mandatory | link
| Unit of age
|  |  | ageMax
| 0 … 1 | link
| Eligibility criteria: Maximum age
|  |  |  | number
| 1 … 1 Mandatory | link
| Maximum eligible age Short input help: If age is less than 1 year, please indicate a value in months, weeks, days, hours, minutes, or weeks of gestation.
|  |  |  | timeUnit
| 1 … 1 Mandatory | link
| Unit of age
|  |  | genders
| 0 … * | link
| Eligible gender Short input help: Select all that apply. If no gender was explicitly excluded in the [RESOURCE], 'Male', 'Female', and 'Diverse' should be selected.
|  |  | inclusionCriteria
| 0 … 1 | link
| Inclusion criteria Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.
|  |  | exclusionCriteria
| 0 … 1 | link
| Exclusion criteria Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.
|  | population
| 1 … 1 Mandatory | nfdhtfcov19-dataelement-139link
| Population of the [RESOURCE]
|  |  | coverage
| 0 … 1 | nfdhtfcov19-dataelement-140link
| Coverage Short input help: Select one value from the list.
|  |  | countries
| 1 … * Mandatory | link
| Country(ies) Short input help: Select all that apply.
|  |  | region
| 0 … 1 | link
| Region(s) and/or city(ies)
|  |  | description
| 0 … 1 | link
| Population description Short input help: Any information important for the given [RESOURCE] population can be specified here.
|  |  | targetSampleSize
| 0 … 1 Conditional | link
| 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")
|  |  | obtainedSampleSize
| 0 … 1 | link
| Obtained sample size
|  | ageMinExamined
| 1 … 1 Required | link
| Actual minimum age of participants
|  |  | number
| 1 … 1 Required | link
| Actual minimum age of participants
|  |  | timeUnit
| 1 … 1 Required | link
| Unit of time
|  | ageMaxExamined
| 1 … 1 Required | link
| Actual maximum age of participants
|  |  | number
| 1 … 1 Required | link
| Actual maximum age of participants
|  |  | timeUnit
| 1 … 1 Required | link
| Unit of time
|  | hypothesis
| 0 … * Conditional | link
| 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 | link
| 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"
|  |  | label
| 1 … 1 Mandatory | link
| Name of the arm
|  |  | type
| 1 … 1 Mandatory | link
| Role of the arm Short input help: Select one value from the list.
|  |  | description
| 0 … 1 | link
| Additional information about the arm
|  | groups
| 0 … * Conditional | nfdhtfcov19-dataelement-141link
| 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"
|  |  | label
| 1 … 1 Mandatory | nfdhtfcov19-dataelement-142link
| Name of the group
|  |  | description
| 0 … 1 | nfdhtfcov19-dataelement-143link
| Additional information about the group
|  | interventions
| 0 … * Conditional | link
| 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"
|  |  | name
| 1 … 1 Mandatory | link
| Name of the intervention Short input help: If the same intervention is associated with more than one arm, please provide the information once and use the field 'Name(s) of the arm(s) associated with the given intervention' to associate it with more than one arm.
|  |  | type
| 0 … 1 | link
| Type of the intervention
|  |  | description
| 0 … 1 | link
| Additional information about the intervention
|  |  | armsLabel
| 0 … * | link
| Name(s) of the arm(s) associated with the given intervention
|  | exposures
| 0 … * Conditional | nfdhtfcov19-dataelement-144link
| 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"
|  |  | name
| 0 … 1 Conditional | nfdhtfcov19-dataelement-145link
| Name of the exposure Short input help: If the same exposure is associated with more than one group, please provide the information once and use the field 'Name(s) of the group(s) associated with the given exposure' to associate it with more than one group.
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")
|  |  | type
| 0 … 1 | nfdhtfcov19-dataelement-146link
| Type of the exposure
|  |  | description
| 0 … 1 | nfdhtfcov19-dataelement-147link
| Additional information about the exposure
|  |  | groupsLabel
| 0 … * Conditional | nfdhtfcov19-dataelement-148link
| 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 … * | link
| Outcome measures in the [RESOURCE]
|  |  | title
| 1 … 1 Mandatory | link
| Name of the outcome measure Short input help: For non-interventional studies, you can provide specific measurement(s) or observation(s) used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
|  |  | description
| 0 … 1 | link
| Description of the outcome measure
|  |  | type
| 0 … 1 Conditional | link
| 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
|  |  | timeFrame
| 0 … 1 | link
| Time point(s) of assessment
|  | comment
| 0 … 1 | link
| Additional information about the [RESOURCE] Short input help: You can provide here specific aspects of the [RESOURCE] that could not be captured by other fields.
|  | assessments
| 0 … * | link
| Additional assessments/measurements in the [RESOURCE] Short input help: Select all that apply.
|  | dataSharingPlan
| 1 … 1 Mandatory | link
| Data sharing strategy of the [RESOURCE]
|  |  | generally
| 1 … 1 Mandatory | link
| Is it planned to share the data? Short input help: Select one value from the list.
|  |  | supportingInformation
| 0 … * Conditional | link
| Supporting documents available in addition to the data Short input help: Select all that apply.
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"
|  |  | timeFrame
| 0 … 1 Conditional | link
| 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"
|  |  | accessCriteria
| 0 … 1 Conditional | link
| Criteria for data access Short input help: Please provide here with whom, for which types of analyses and by what mechanism the data will be shared.
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"
|  |  | description
| 0 … 1 | link
| Additional information about data sharing Short input help: Please indicate here which data in particular will be shared, or the reasons why it will not be shared or it is not yet decided.
|  |  | datashield
| 0 … 1 | link
| DataSHIELD/Opal infrastructure available?
|  |  | requestData
| 0 … 1 | nfdhtfcov19-dataelement-149link
| Link to data request application
|  |  | url
| 0 … 1 | link
| Web page with additional information about data sharing
|  |  | recordLinkage
| 0 … 1 Conditional | nfdhtfcov19-dataelement-150link
| 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 | link
| 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"
|  |  | timePerspectives
| 0 … * Conditional | link
| Temporal design Short input help: Is it a retrospective, prospective or cross-sectional [RESOURCE]?
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")
|  |  | targetFollowUpDuration
| 0 … 1 | nfdhtfcov19-dataelement-151link
| Target follow-up duration of the [RESOURCE]
|  |  |  | number
| 1 … 1 Mandatory | nfdhtfcov19-dataelement-152link
| Target follow-up duration
|  |  |  | timeUnit
| 1 … 1 Mandatory | nfdhtfcov19-dataelement-153link
| Unit of time
|  |  |  | frequency
| 0 … 1 | nfdhtfcov19-dataelement-154link
| Number of follow-ups conducted
|  |  | targetFollowUpDuration
| 1 … 1 Required | link
| Target follow-up duration Short input help: The value must be provided in years.
|  |  | biospecimenRetention
| 0 … * | link
| Biosamples retained in a biorepository Short input help: Select all that apply.
|  |  | biospecimenDescription
| 0 … 1 Conditional | link
| Specific types of retained biosamples Short input help: You can provide here specific types of retained biosamples (e.g. blood, serum, urine, etc.).
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 | link
| 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"
|  |  | phase
| 0 … 1 | link
| Numerical phase Short input help: Select one value from the list.
|  |  | masking
| 0 … 1 | link
| Masking of intervention(s) assignment
|  |  |  | general
| 0 … 1 | link
| Masking implemented?
|  |  |  | roles
| 0 … * Conditional | link
| Who is masked? Short input help: Select all that apply.
Card/Conf | Condition
--- | ---
0 … * | 0..*, if Design.interventional.masking.general == true
0 … 0 Not permitted | 0..0, if Design.interventional.masking.general == false
|  |  |  | description
| 0 … 1 Conditional | link
| Additional information about masking Short input help: You can provide here additional information about masking, e.g. other parties who may be masked.
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
|  |  | allocation
| 0 … 1 | link
| Type of allocation of participants to an arm Short input help: Select one value from the list.
|  |  | offLabelUse
| 0 … 1 | link
| Off-label use of a drug product Short input help: Select 'Yes' or 'No' only for a drug [RESOURCE] and 'Not applicable' for any other [RESOURCE].
| Resource
| 0 … * | link
| Resource
|  | provenance
| 1 … 1 Required | link
| Information about provenance aspects of the data entry
|  |  | dataSource
| 1 … 1 Required | link
| Source of information about the [RESOURCE]
|  |  | verificationDate
| 1 … 1 Required | link
| Verfication date
|  |  | verificationUser
| 1 … 1 Required | link
| User who last verified the [RESOURCE]
|  |  | firstSubmittedDate
| 1 … 1 Required | link
| Date when the [RESOURCE] was first submitted for publication
|  |  | firstSubmittedUser
| 1 … 1 Required | link
| User who first submitted the [RESOURCE] for publication
|  |  | firstPostedDate
| 1 … 1 Required | link
| Date when the [RESOURCE] was first posted/published
|  |  | firstPostedUser
| 1 … 1 Required | link
| User who first posted/published the [RESOURCE]
|  |  | lastUpdateSubmittedDate
| 1 … 1 Required | link
| Date when the last update of the resource was submitted for publication.
|  |  | lastUpdateSubmittedUser
| 1 … 1 Required | link
| User who submitted the last update of the [RESOURCE]
|  |  | lastUpdatePostedDate
| 1 … 1 Required | link
| Date when the last update of the [RESOURCE] was posted/published
|  |  | lastUpdatePostedUser
| 1 … 1 Required | link
| User who posted/published the last update
|  |  | resourceVersion
| 1 … 1 Required | link
| Version number of the resource within the portal/system