This control plane turns trial deviation data into one buyer-readable surface: missing source proof, retraining gaps, CAPA pressure, stale safety attachments, and the packets needed before inspection or quality trust slips.
| Gap | Owner | Subject | Principal | Message |
|---|---|---|---|---|
| high protocol-deviation-gap |
Clinical Quality | ONC-241 Phase II DEV-1042 Boston Investigational Site 07 |
— | ONC-241 Phase II case DEV-1042 still has open deviation debt against the Source data reconciliation packet packet. |
| high protocol-deviation-gap |
Regulatory Affairs | IMM-330 Extension DEV-3109 Dallas Site 04 |
— | IMM-330 Extension case DEV-3109 still has open deviation debt against the CAPA and retraining packet packet. |
| high missing-source-proof |
Clinical Quality | ONC-241 Phase II Source Dose escalation |
Visit source confirmation | Source packet is still missing the signed visit-source confirmation referenced in the monitoring note. |
| high stale-open-packet |
Clinical Quality | Source Dose escalation |
Visit source confirmation | Source evidence has been open longer than the deviation review SLA. |
| high missing-capa-proof |
Regulatory Affairs | IMM-330 Extension CAPA Open-label extension |
CAPA chronology | CAPA packet is missing the final chronology tying the accountability mismatch to the corrective action plan. |
| high stale-open-packet |
Regulatory Affairs | CAPA Open-label extension |
CAPA chronology | CAPA evidence has been open longer than the deviation review SLA. |
| medium workflow-gap |
Clinical Quality | ONC-241 Phase II DEV-1042 Boston Investigational Site 07 |
— | Owner-safe routing is degraded; the protocol deviation, CAPA, and review sequence are still split across teams. |
| medium missing-source-proof |
Regulatory Affairs | IMM-330 Extension DEV-3109 Dallas Site 04 |
— | The deviation is in exception flow but does not currently show a clean source-data proof packet in the queue. |
| medium workflow-gap |
Regulatory Affairs | IMM-330 Extension DEV-3109 Dallas Site 04 |
— | Owner-safe routing is degraded; the protocol deviation, CAPA, and review sequence are still split across teams. |
| medium missing-training-proof |
Site Training | ONC-241 Phase II Training Dose escalation |
Retraining signoff | Coordinator retraining proof does not yet reconcile the delayed transcription event. |
| medium stale-open-packet |
Site Training | Training Dose escalation |
Retraining signoff | Training evidence has been open longer than the deviation review SLA. |
| medium stale-open-packet |
Safety Operations | Safety Open-label extension |
Safety narrative appendix | Safety evidence has been open longer than the deviation review SLA. |