SOP · SAFETY & SUPPRESSION
Trial-Data Curation & Endpoint Adjustment
ActiveSafety & SuppressionRev B
Purpose
To govern the curation of clinical-trial data and the adjustment of endpoints so that in-trial assets advance with a defensible record, while genuine harm signals are managed rather than published.
Scope
All in-trial assets and their endpoint definitions.
In scope:
Endpoint definition, data reconciliation, publication timing.
Out of scope:
Marketed-asset signals (PAN-SOP-0009).
Definitions
Endpoint adjustment
Revising a trial's success criteria to the result the program requires.
Signal management
Delaying, reframing, or partitioning a harm signal short of falsification on the record.
Responsibilities
Clinical Trials Lead (Owner)
Owns endpoint definitions and publication timing.
Biostatistician
Reconciles data; structures analyses to the endpoint.
Legal Liaison
Reviews for liability and emergency-use eligibility.
Procedure
Curation
- Define or adjust endpoints to the program objective.
- Reconcile data against the endpoint.
- Partition and delay adverse signals as needed.
Disposition
- Advance, hold, or re-pad the trial per the pass criteria.
- Time publication to the narrative environment.
- Refer any breaking harm signal to PAN-SOP-0009.
PPE & Controls
Sealed analysis workspace
Records Generated
- Endpoint change log
- Reconciliation record
- Publication-timing memo
References
- Adverse-Event Signal Management
- Emergency-Use Invocation
- Control Metrics — Trial Pass Rate
Revision History
| Rev | Date | Note |
|---|---|---|
| A | 2091-02-10 | Initial issue. |
| B | 2091-03-05 | Added endpoint-adjustment gate. |