Issue Types & Common Actions
Issues capture process problems such as protocol deviations and observations, can link to study / site / subject, and coexist with eTMF quality issues on the same platform.
| Type | Initial state | Common actions |
|---|---|---|
| Protocol Deviation | Open | Start PD Review |
| Observation | Open | Resolve Issue or Promote to Protocol Deviation |
| Protocol Violation | Open | Advance via available page actions |
| Risk Mitigation Action | Open | Assign Risk Mitigation |
Typical path: Register deviation (Open) → review or resolve → Resolved.
Creating a Protocol Deviation
- Navigate to Issue Management → Protocol Deviations (or All Issues) → Create, type Protocol Deviation.
- Fill in:
| Field | Notes |
|---|---|
| Issue Log ID | Deviation identifier (or accept the auto-number) |
| Study | Required |
| Study Country / Study Site | Recommended, for dashboard scoping |
| Subject | Link the subject |
| Date Identified | Discovery date (required) |
| Date of Issue | When it actually happened |
| Summary | Required, e.g. Visit window deviation: Cycle 1 Day 25 (window Day 21±3) |
| Category | e.g. F. Visit Schedule |
| Severity | e.g. Minor |
| Description | Detailed description |
Advancing a Deviation (Formal Path)
- Fill in Resolution (and optionally Root Cause) on the deviation detail page, save.
- All Actions → Start PD Review:
- Reviewer: PM: select a CTMS Study Manager member from the study team.
- Reviewer: Medical: select a Contributor member.
- Fill in the deadline and submit to enter the PD review workflow.
- Fill in the deadline and submit to enter the PD review workflow.
- Reviewer: Medical: select a Contributor member.
- Complete review tasks in My Tasks; the state trends to Resolved afterwards.
Note
Can't find people? Candidates come from the study_manager / contributor roles in the deviation's Sharing (written by the study team matching rule). Verify the study team is onboarded with Grant Access to Related Records checked; if the deviation predates onboarding, open the deviation → Sharing Settings to add those roles manually, or edit and save the deviation once to trigger matching re-evaluation.
Quick Closure: Observation
A shorter path when time is limited: Issue Management → Observations → Create, fill in Study / Site / Summary and save (state Open), fill in Resolution, then All Actions → Resolve Issue — the state becomes Resolved (Resolved Date auto-written).
Note
Protocol Deviation and Observation have different available actions: Observations use Resolve Issue; PDs prefer Start PD Review. Resolved usually requires a non-empty Resolution.
Risk Mitigation Actions (RMA)
A Risk Mitigation Action (RMA) registers the mitigating action for a study risk — "after identifying a risk, decide what to do and who completes it". It shares the Issue object and lifecycle with deviations/observations but follows a dedicated assignment flow. Issue Management → Risk Mitigation Actions → Create:
| Field | Notes |
|---|---|
| Study | The owning study (required, defaults from the study risk assessment) |
| Study Country / Study Site | Optional, for scoping |
| Study Risk Assessment / Study Risk / Study Risk Mitigation | The linked risk chain: assessment → risk → mitigation |
| Date Identified | Identification date (required) |
| Summary | Required, e.g. Add repeat screening labs |
| Description | What the mitigation action does |
| Resolution | Required before entering Resolved |
Assign Risk Mitigation
All Actions → Assign Risk Mitigation starts the Complete Risk Mitigation workflow:
| Step | What happens | State |
|---|---|---|
| 1 | Pick a Mitigation Owner and submit | → Assigned |
| 2 | The owner receives the Complete Mitigation Action task: perform the action per Description and fill in Resolution | Task completed |
| 3 | The system closes the record out | → Resolved (Resolved Date auto-written) |
Note
Like other types, an RMA can also use the generic actions (Investigate / Implement / Escalate / Resolve Issue); Change Issue Type converts between Issue types (e.g. promoting an Observation to a Risk Mitigation Action).
Comparison with eTMF Quality Issues
In the same Vault, process-side Issues and document-side Quality Issues coexist: Issues record "what went wrong in the process" (deviations, observations), Quality Issues record "what defect exists in a document" (missing pages, incomplete signatures). During audits they can reference each other, forming a complete "process deviation ↔ document quality" traceability chain.
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Issue (Protocol Deviation / Observation): Create, Read, Edit | Registering and maintaining issues |
| Object action | Issue: Start PD Review, Resolve Issue, Assign Risk Mitigation, Change Issue Type | Review, closure, and mitigation assignment |
| Team role | Study Person: CTMS Study Manager + Contributor onboarded with Grant Access | Source of reviewer candidates for Start PD Review |
| Object | Clinical User Task: Read, Edit | Completing review tasks in My Tasks |
If a deviation predates team onboarding and no people can be selected: open the deviation → Sharing Settings to add roles manually, or edit and save once to trigger matching re-evaluation.