Packet Artifact
04 initial risk register
DIAB-220 Initial Risk Register
Training-use boundary: This is a fictional teaching artifact for clinical project-management practice. It is not a protocol, SAP, consent form, regulatory submission, SOP, validation package, or sponsor-approved record. Real study use requires medical, statistical, regulatory, quality, legal, privacy, safety, and operational review.
| Risk | Cause / Signal | Initial Rating | Accountable Owner | Trigger | Mitigation Before Initiation | Contingency / Escalation | Review Cadence |
|---|---|---|---|---|---|---|---|
| Endpoint credibility | Endpoint data are incomplete, inconsistent, mistimed, or not traceable. | High | Medical / Biostatistics / Data | Endpoint-critical procedure or transfer lacks tested evidence | Map endpoint-critical procedures, vendors, systems, visit windows, and data checks before initiation. | Escalate to governance if the primary endpoint path cannot be proven before SIV release. | Monthly until startup release; weekly if trigger appears |
| Enrollment feasibility | Target population or criteria produce slower enrollment or high screen failure. | High | Clinical Operations / Site Feasibility | Screening assumptions depend on unverified site enthusiasm | Require site feasibility evidence, screening assumptions, country/site mix, and rescue triggers. | Escalate if forecasted FPI or enrollment rate lacks site-level evidence. | Monthly until startup release; weekly if trigger appears |
| Participant protection | Consent, safety follow-up, privacy, burden, or communication risk is underestimated. | High | Medical / Safety / Regulatory / Patient Engagement | Participant-facing material, safety pathway, or burden review remains incomplete | Review with Medical, Safety, Regulatory, Ethics, Patient Engagement, and Quality. | Escalate immediately if consent, safety reporting, or privacy controls are not ready. | Monthly until startup release; weekly if trigger appears |
| Vendor/system readiness | Vendor, CRO, EDC, IRT, eCOA, lab, imaging, or device workflow is not ready when sites activate. | Medium | Priya Raman / Victor Stein / Owen Fletcher | UAT, transfer test, help desk, or system release evidence is missing | Create vendor readiness checklist, UAT evidence, interface map, and escalation path. | Hold release of endpoint-critical work until acceptance evidence is complete. | Monthly until startup release; weekly if trigger appears |
| Budget/scope drift | Original budget does not reflect actual protocol, vendor, site, or data requirements. | Medium | Maya Desai / Procurement / Finance | Protocol or vendor assumption changes without budget update | Tie budget assumptions to WBS, SOW, pass-throughs, timeline, and contingency. | Route change order or rebaseline decision through governance. | Monthly until startup release; weekly if trigger appears |
| Inspection evidence gap | The team cannot prove what was decided, why, by whom, and with what evidence. | High | Grace Kim / Helen Park / PM | Decision, approval, training, or oversight record is missing from the evidence map | Set TMF plan, decision log, issue log, risk register, and evidence package before initiation. | Escalate when an essential record cannot be retrieved or reconstructed. | Monthly until startup release; weekly if trigger appears |
PMBOK Use
This file is the project-specific seed for the RAID log and risk register. Lauren should transfer each accepted risk into the live project risk register, preserve the owner and trigger fields, and ask Daniel Liang to review any risk that crosses participant protection, primary endpoint, inspection-readiness, or governance-decision thresholds.