Release v5.0.0

Major Updates:

• Add ClinicalTrial Class
  • Note that clinicalStudyDesign and eligibilityCriteria slots have been removed
• Add ParticipantDataFileManifest Class for and add slot participantDataFileManifestLocation to DataFile

Minor Updates

• Add enums to enum_researchDomain:
  • Auditory Perception
  • Embryonic and Fetal Development
  • Neurodevelopmental Disorders
  • Nutritional and Metabolic Diseases
  • Psychiatric Disorders
  • Respiratory Tract Diseases
  • Social Determinants of Health
• Add enums to enum_studyDesign:
  • Trial Readiness Study
  • Technology Development
• Add enums to enum_dataCategory
  • Adherence
  • changed "Sleep Study" to "Sleep"
  • removed "Harmonized" from "Harmonized Demographic/Clinical Data" for use in Study::Expected Data Category (continue to use "Unharmonized Demographic/Clinical Data" for Datasets and DataFiles)
• Add enums to enum_clinicalDataSourceType:
  • Wearable
• Add enums to enum_studyCode:
  • APAP21
  • ASPIRE
  • ARC-DS
  • DS-HPBM
  • EACH-DS
  • HomeGrown
  • MOSAIC-DS
  • TOPS-DS
• Make the following slots multivalued = true:
  • studyWebsite
  • dataType
  • otherRepository
• Add enum_Unknown to range for ageAtFirstParticipantEngagement and ageAtBiospecimenCollection
• Update description of Family ID to specify not required for Proband-only individuals
• Clarify in slot descriptions that Parent and Collection info is required for each Sample, and that each Parent and Collection must also be listed as a Sample
• change title of guidMapped from "GUIDs Mapped?" to "GUID Mapped"

Known Bugs:

Auto-generation of the documentation site for this model is currently broken and still shows the previous release (v4.0.0). A fix is in progress.

---

Full Changelog: v4.0.0...v5.0.0