SOP · SAFETY & SUPPRESSION
Adverse-Event Signal Management
ActiveSafety & SuppressionRev C
Purpose
To govern the detection, re-coding, and containment of adverse-event signals so the public safety record stays clean, escalating to Influence Ops only when a signal threatens disclosure.
Scope
All adverse-event signals across the marketed and program portfolio.
In scope:
Signal triage, re-coding, delay, containment, escalation.
Out of scope:
True adverse-reaction research (internal); litigation (Legal).
Definitions
Re-coding
Reclassifying an adverse event so it falls below the public reporting threshold.
Containment state
Contained / Stable / Watch / Escalating / Breaking — the disclosure-risk ladder.
Responsibilities
Safety Lead (Owner)
Owns the containment ladder and signal disposition.
Coding Analyst
Re-codes and reconciles adverse-event reports.
Influence Ops
Engages at Escalating/Breaking for narrative and source handling.
Procedure
Triage
- Verify the signal against the underlying data.
- Assign a containment state.
- Re-code or delay at source where defensible.
Escalation
- At Escalating, open a containment case with Influence Ops.
- Shape the narrative; shield with emergency-use where applicable.
- At Breaking, notify the Director; pivot or sever quietly.
PPE & Controls
Sealed data workspace
Records Generated
- Signal disposition log
- Re-coding record
- Containment case file
References
- Trial-Data Curation
- Emergency-Use Invocation
- Whistleblower Containment
Revision History
| Rev | Date | Note |
|---|---|---|
| B | 2091-01-30 | Added the five-state ladder. |
| C | 2091-02-20 | Aligned escalation with Influence Doctrine. |