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final Scenario Design3.3 2.16.840.1.113883.3.1937.777.64.3.4

Name Details [‑]
final Design3.3
nfdhtfcov19-scenario-4
Version / effective date v3.3 - 2023‑12‑21
final doublearrow NFDI4Health Resource
nfdhtfcov19-transaction-7link
Version / effective date v3.3 - 2023‑12‑21    
final arrowright NFDI4Health Resource
nfdhtfcov19-transaction-8link
Version / effective date v3.3 - 2023‑12‑21    
Actor
Sender (person) Researcher
Associations
Contained concepts
Concept Card/Conf Id
folder 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")
treetree final  primaryDesign
0 … 1 Conditional

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")
treetree folder 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")
treeblank treetree final  interventional
0 … * Conditional

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"
treeblank treetree final  nonInterventional
0 … * Conditional

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"
treetree folder conditions
0 … *

Primary health condition(s) or disease(s) considered in the [RESOURCE]
treeblank treetree final  label
1 … 1 Mandatory

Primary health condition or disease name

Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
treeblank treetree final  classification
1 … 1 Mandatory

Terminology/classification

Short input help: If used, name of the terminology/classification.
treeblank treetree final  code
0 … 1

Code of the health condition or disease

Short input help: If known, you can provide the code from the terminology/classification used.
treetree folder focus
0 … *
nfdhtfcov19-dataelement-132link

Primary focus of the [RESOURCE]
treeblank treetree final  label
1 … 1 Mandatory
nfdhtfcov19-dataelement-133link

Focus area

Short input help: Preferably, use terms from SNOMED CT (https://browser.ihtsdotools.org).
treeblank treetree final  classification
1 … 1 Mandatory
nfdhtfcov19-dataelement-134link

Terminology/classification

Short input help: If used, name of the terminology/classification.
treeblank treetree final  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.
treetree folder groupsOfDiseases
1 … 1 Mandatory

Groups of diseases or conditions
treeblank treetree final  generally
1 … * Mandatory

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.
treeblank treetree final  conditions
0 … *

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.
treetree final  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")
treetree folder 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")
treeblank treetree final  ethicsCommiteeApproval
0 … 1

Status of the ethics committee approval
treeblank treetree final  status
0 … 1 Conditional

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")
treeblank treetree final  statusWhenIntervention
0 … 1 Conditional

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")
treeblank treetree final  stageStopped
0 … 1 Conditional

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")
treeblank treetree final  reasonStopped
0 … 1 Conditional

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")
treeblank treetree final  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")
treeblank treetree final  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"
treeblank treetree final  startDate
0 … 1

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.
treeblank treetree final  endDate
0 … 1

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.
treetree final  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")
treetree final  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"
treetree final  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")
treetree final  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"
treetree final  subject
1 … 1 Mandatory

Primary subject

Short input help: Select one value from the list.
treetree folder 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")
treeblank treetree final  method
1 … 1 Mandatory

Applied sampling method

Short input help: Select one value from the list.
treeblank treetree final  probabilityMethod
0 … 1 Conditional

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"
treeblank treetree final  nonProbabilityMethod
0 … 1 Conditional

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"
treetree folder dataSource
0 … 1

Data sources of the [RESOURCE]
treeblank treetree final  general
0 … *

Type(s) of data sources

Short input help: Select all that apply.
treeblank treetree final  biosamples
0 … * Conditional

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"
treeblank treetree final  imaging
0 … * Conditional

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"
treeblank treetree final  omics
0 … * Conditional

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"
treeblank treetree final  description
0 … 1

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.
treetree final  primaryPurpose
0 … 1 Conditional

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")
treetree folder eligibilityCriteria
0 … 1

Eligibility criteria for [RESOURCE] participants
treeblank treetree folder ageMin
0 … 1

Eligibility criteria: Minimum age
treeblank treeblank treetree final  number
1 … 1 Mandatory

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.
treeblank treeblank treetree final  timeUnit
1 … 1 Mandatory

Unit of age
treeblank treetree folder ageMax
0 … 1

Eligibility criteria: Maximum age
treeblank treeblank treetree final  number
1 … 1 Mandatory

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.
treeblank treeblank treetree final  timeUnit
1 … 1 Mandatory

Unit of age
treeblank treetree final  genders
0 … *

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.
treeblank treetree final  inclusionCriteria
0 … 1

Inclusion criteria

Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.
treeblank treetree final  exclusionCriteria
0 … 1

Exclusion criteria

Short input help: If possible, use an enumerated or bulleted list for each criterion, starting with '-' and finishing with ';'.
treetree folder population
1 … 1 Mandatory
nfdhtfcov19-dataelement-139link

Population of the [RESOURCE]
treeblank treetree final  coverage
0 … 1
nfdhtfcov19-dataelement-140link

Coverage

Short input help: Select one value from the list.
treeblank treetree final  countries
1 … * Mandatory

Country(ies)

Short input help: Select all that apply.
treeblank treetree final  region
0 … 1

Region(s) and/or city(ies)
treeblank treetree final  description
0 … 1

Population description

Short input help: Any information important for the given [RESOURCE] population can be specified here.
treeblank treetree final  targetSampleSize
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")
treeblank treetree final  obtainedSampleSize
0 … 1

Obtained sample size
treetree folder ageMinExamined
1 … 1 Required

Actual minimum age of participants
treeblank treetree cancelled  number
1 … 1 Required

Actual minimum age of participants
treeblank treetree cancelled  timeUnit
1 … 1 Required

Unit of time
treetree folder ageMaxExamined
1 … 1 Required

Actual maximum age of participants
treeblank treetree cancelled  number
1 … 1 Required

Actual maximum age of participants
treeblank treetree cancelled  timeUnit
1 … 1 Required

Unit of time
treetree final  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")
treetree folder 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"
treeblank treetree final  label
1 … 1 Mandatory

Name of the arm
treeblank treetree final  type
1 … 1 Mandatory

Role of the arm

Short input help: Select one value from the list.
treeblank treetree final  description
0 … 1

Additional information about the arm
treetree folder 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"
treeblank treetree final  label
1 … 1 Mandatory
nfdhtfcov19-dataelement-142link

Name of the group
treeblank treetree final  description
0 … 1
nfdhtfcov19-dataelement-143link

Additional information about the group
treetree folder 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"
treeblank treetree final  name
1 … 1 Mandatory

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.
treeblank treetree final  type
0 … 1

Type of the intervention
treeblank treetree final  description
0 … 1

Additional information about the intervention
treeblank treetree final  armsLabel
0 … *

Name(s) of the arm(s) associated with the given intervention
treetree folder 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"
treeblank treetree final  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")
treeblank treetree final  type
0 … 1
nfdhtfcov19-dataelement-146link

Type of the exposure
treeblank treetree final  description
0 … 1
nfdhtfcov19-dataelement-147link

Additional information about the exposure
treeblank treetree final  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")
treetree folder outcomes
0 … *

Outcome measures in the [RESOURCE]
treeblank treetree final  title
1 … 1 Mandatory

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.
treeblank treetree final  description
0 … 1

Description of the outcome measure
treeblank treetree final  type
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
treeblank treetree final  timeFrame
0 … 1

Time point(s) of assessment
treetree final  comment
0 … 1

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.
treetree final  assessments
0 … *

Additional assessments/measurements in the [RESOURCE]

Short input help: Select all that apply.
treetree folder dataSharingPlan
1 … 1 Mandatory

Data sharing strategy of the [RESOURCE]
treeblank treetree final  generally
1 … 1 Mandatory

Is it planned to share the data?

Short input help: Select one value from the list.
treeblank treetree final  supportingInformation
0 … * Conditional

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"
treeblank treetree final  timeFrame
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"
treeblank treetree final  accessCriteria
0 … 1 Conditional

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"
treeblank treetree final  description
0 … 1

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.
treeblank treetree final  datashield
0 … 1

DataSHIELD/Opal infrastructure available?
treeblank treetree final  requestData
0 … 1
nfdhtfcov19-dataelement-149link

Link to data request application
treeblank treetree final  url
0 … 1

Web page with additional information about data sharing
treeblank treetree final  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"
treetree folder 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"
treeblank treetree final  timePerspectives
0 … * Conditional

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")
treeblank treetree folder targetFollowUpDuration
0 … 1
nfdhtfcov19-dataelement-151link

Target follow-up duration of the [RESOURCE]
treeblank treeblank treetree final  number
1 … 1 Mandatory
nfdhtfcov19-dataelement-152link

Target follow-up duration
treeblank treeblank treetree final  timeUnit
1 … 1 Mandatory
nfdhtfcov19-dataelement-153link

Unit of time
treeblank treeblank treetree final  frequency
0 … 1
nfdhtfcov19-dataelement-154link

Number of follow-ups conducted
treeblank treetree cancelled  targetFollowUpDuration
1 … 1 Required

Target follow-up duration

Short input help: The value must be provided in years.
treeblank treetree final  biospecimenRetention
0 … *

Biosamples retained in a biorepository

Short input help: Select all that apply.
treeblank treetree final  biospecimenDescription
0 … 1 Conditional

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"
treetree folder 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"
treeblank treetree final  phase
0 … 1

Numerical phase

Short input help: Select one value from the list.
treeblank treetree folder masking
0 … 1

Masking of intervention(s) assignment
treeblank treeblank treetree final  general
0 … 1

Masking implemented?
treeblank treeblank treetree final  roles
0 … * Conditional

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
treeblank treeblank treetree final  description
0 … 1 Conditional

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
treeblank treetree final  allocation
0 … 1

Type of allocation of participants to an arm

Short input help: Select one value from the list.
treeblank treetree final  offLabelUse
0 … 1

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].
folder Resource
0 … *

Resource
treetree folder provenance
1 … 1 Required

Information about provenance aspects of the data entry
treeblank treetree cancelled  dataSource
1 … 1 Required

Source of information about the [RESOURCE]
treeblank treetree cancelled  verificationDate
1 … 1 Required

Verfication date
treeblank treetree cancelled  verificationUser
1 … 1 Required

User who last verified the [RESOURCE]
treeblank treetree cancelled  firstSubmittedDate
1 … 1 Required

Date when the [RESOURCE] was first submitted for publication
treeblank treetree cancelled  firstSubmittedUser
1 … 1 Required

User who first submitted the [RESOURCE] for publication
treeblank treetree cancelled  firstPostedDate
1 … 1 Required

Date when the [RESOURCE] was first posted/published
treeblank treetree cancelled  firstPostedUser
1 … 1 Required

User who first posted/published the [RESOURCE]
treeblank treetree cancelled  lastUpdateSubmittedDate
1 … 1 Required
Date when the last update of the resource was submitted for publication.
treeblank treetree cancelled  lastUpdateSubmittedUser
1 … 1 Required

User who submitted the last update of the [RESOURCE]
treeblank treetree cancelled  lastUpdatePostedDate
1 … 1 Required

Date when the last update of the [RESOURCE] was posted/published
treeblank treetree cancelled  lastUpdatePostedUser
1 … 1 Required

User who posted/published the last update
treeblank treetree cancelled  resourceVersion
1 … 1 Required

Version number of the resource within the portal/system