Data Safety Monitoring Board (DSMB) Charter — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-DSMB |
| Version | 2.0 (full) |
| Study No. | GLPI103-301 |
| Standard | FDA DMC guidance; EMA; ICH E6(R3) |
| Confidentiality | Confidential — TMF |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical / PV | Initial charter |
| 2.0 | 2026-06-29 | Clinical / PV | Full charter — composition, procedures, data flow, stopping guidance |
1. Purpose
The DSMB (IDMC) is an independent body that periodically reviews accumulating unblinded safety data (and any interim efficacy) to protect participants and study integrity.
2. Composition & Independence
≥3 voting independent members: an endocrinologist/diabetologist, a cardiologist (mechanism-relevant), and an independent biostatistician; a voting Chair. Members have no financial/intellectual conflicts and are independent of the sponsor study team. An independent unblinded statistician (not a board member) prepares closed reports.
3. Responsibilities
- Review TEAEs, AESIs (GI, pancreatitis, MTC, hypoglycaemia, cardiovascular/heart-rate), SAEs, deaths, discontinuations, and relevant laboratory trends.
- Assess benefit–risk and recommend continue / modify / pause / stop.
- Review any interim analysis per SAP-301.
4. Meetings & Data Flow
Organizational meeting before first subject; safety reviews at predefined enrollment/exposure milestones (e.g., ~25%, 50%, 75% enrolled) and ad hoc for emerging signals. Open session (sponsor may attend) + closed session (unblinded; board + independent statistician only). Recommendations are minuted (TMF-DSMB-MIN).
5. Stopping Guidance
Considerations for unacceptable safety (e.g., excess SAEs, pancreatitis cluster, cardiovascular signal, severe hypoglycaemia imbalance). Any interim efficacy/futility would use pre-specified statistical boundaries (alpha spending; SAP-301 §11). Recommendations are advisory to the sponsor.
6. Confidentiality & Records
Members maintain strict confidentiality; unblinded outputs are restricted; minutes (open/closed) are retained in the TMF. Operating procedures and quorum (majority; Chair tie-break) are defined herein.