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Sidebar Menu (Revised)

Study

  1. Dashboard
  2. Study overview, enrollment, data completeness, quality and safety signals
  3. Participants
  4. Participant enrollment, consent status, eligibility, withdrawal
  5. Entry point for participant-centric actions
  6. Data Entry
  7. Role-centric data entry (CRFs, ClinRO, ObsRO)
  8. Forms to complete, in progress, or reopened
  9. Assessments
  10. Participant-completed assessments (jsPsych / eCOA)
  11. Quality, compliance, and issue-centric operational view
  12. eConsent
  13. Consent execution and status monitoring
  14. Participant signatures, re-consent tracking, withdrawals
  15. Visits / Schedule
  16. Study calendar and visit spine
  17. Visit windows, missed/out-of-window visits, unscheduled events
  18. Queries & Safety
  19. Data queries and discrepancy management
  20. Adverse Events, Serious Adverse Events, expedited safety workflows
  21. Data Review
  22. Review → clean + coding (MedDRA / WHO-DD) → lock → export
  23. Data manager–centric workflows
  24. Reports & Exports
  25. Operational and regulatory reports
  26. Data extracts (ODM, SDTM, ADaM, OMOP)
  27. Audit Trail (global and item-level access)

Configure

  1. Study Design
  2. Authoring and configuration of study structure
  3. Visits, forms, eligibility, protocol logic
  4. Links to Metadata Versions (lifecycle, diffing, approvals)
  5. Assessments Designer
  6. jsPsych module and battery authoring
  7. Battery composition, event binding, versioning
  8. eConsent Designer
  9. Consent document authoring and configuration
  10. Versioning, language variants, signature requirements
  11. Binding to study events and re-consent triggers
  12. Data Standards
  13. Metadata governance and standards management
  14. Includes links to:
    1. Standards & Terminology (CodeLists, Units, Dictionaries)
    2. Rules & Derivations (Edit checks, calculations)
    3. Mappings (ODM ↔ internal model, ODM ↔ SDTM/ADaM/OMOP)

Operations

  1. Sites
  2. Site registry, activation status, performance indicators
  3. Users & Roles
  4. Role assignments, delegation logs, training status
  5. Integrations
  6. FHIR / EHR integrations
  7. Labs, imaging, notification services, identity providers
  8. Settings
  9. System-level and environment configuration
  10. RBAC, notifications, security, audit policies
  11. Help
  12. Protocol documents, SOPs, training materials, support access

Assessments (Study level)

  1. Delivery Queue / Worklist
  2. Not started / In progress / Completed / Expired / Failed / Locked
  3. Participant View
  4. Assessment timeline per participant
  5. Deep link to associated Study Event instance
  6. Completion & Compliance Analytics
  7. Completion rates by site, cohort, and timepoint
  8. Resend / Remind Controls
  9. RBAC-restricted actions with full audit trail
  10. Issue Handling
  11. Device compatibility issues
  12. Connectivity failures
  13. Interrupted or abandoned sessions
  14. Source Data / Raw Signals
  15. Controlled access to raw jsPsych outputs
  16. Export hooks for advanced analysis
  17. Adjudication / Review (if required)
  18. Detection of invalid patterns, suspicious completion, outliers

Assessments Designer (Configure level)

  1. Module Library
  2. Module metadata: domain, duration, device requirements, scoring method
  3. Validation status: draft / validated / deprecated
  4. Version history
  5. Battery Builder
  6. Compose modules into batteries
  7. Ordering, branching, timers, randomization
  8. Instructions and language variants
  9. Event Linking
  10. Bind batteries to StudyEventDef (visits)
  11. Window rules
  12. Reminders and escalations
  13. Availability period
  14. Permitted repeats
  15. Versioning
  16. Battery versions tied to metadata versions (protocol amendments)
  17. Breaking-change warnings (e.g., scoring or structure changes mid-study)
  18. Mappings
  19. Map module outputs to ODM ItemDefs
  20. Downstream alignment with SDTM / ADaM / OMOP

Key requirement:

Batteries must have durable identifiers (OIDs / UUIDs) analogous to Form OIDs, with traceability across versions.

eConsent Designer (Configure level)

  1. Consent Document Library
  2. Consent forms by version and language
  3. IRB/REB identifiers and effective dates
  4. Signature & Workflow Configuration
  5. Participant, LAR, witness, investigator signatures
  6. Ordering and completion rules
  7. Event & Trigger Binding
  8. Initial consent at enrollment
  9. Re-consent triggered by protocol amendment, age-of-majority, or study milestone
  10. Versioning & Governance
  11. Consent version lifecycle
  12. Comparison and approval prior to activation
  13. Mappings
  14. Consent status and dates mapped to ODM and downstream models
  15. Alignment with regulatory exports and audit requirements

Summary judgment

This revised structure:

  • Keeps the sidebar clean and regulator-intuitive
  • Treats jsPsych assessments and eConsent symmetrically as protocol-bound, versioned capabilities
  • Avoids relegating consent to “Integrations” or “Settings”
  • Preserves ODM principles without forcing them into the UI language