Governance & RACI / Phase-Gate Criteria — GLPI-103
| Field | Value |
|---|---|
| Document ID | PM-005 |
| Version | 1.0 |
| Confidentiality | Confidential — portfolio use |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Project Management | Initial governance & RACI |
1. Governance Bodies
- Steering Committee: strategic oversight; Phase-gate Go/No-Go decisions.
- Core Project Team (CPT): cross-functional execution (Clinical, Biostat, RA, CMC, PV, DM, PM).
- DSMB (independent): unblinded safety oversight (TMF-DSMB).
2. RACI (key deliverables)
| Deliverable | Clinical | Biostat/DM | Regulatory | CMC | PV | PM |
|---|---|---|---|---|---|---|
| Protocol / SAP | A/R | R | C | I | C | C |
| CSR / TLFs | A | R | C | I | C | I |
| CDISC datasets / define | I | A/R | C | — | — | I |
| Module 2/3/5 dossier | C | C | A/R | R(M3) | C | C |
| RMP / safety | C | C | C | — | A/R | I |
| Budget / timeline / risk | C | C | C | C | C | A/R |
(R = Responsible, A = Accountable, C = Consulted, I = Informed.)
3. Phase-Gate Decision Criteria
| Gate | Trigger | Go criteria |
|---|---|---|
| Gate 1 | After FIH SAD (101) | Acceptable safety/PK |
| Gate 2 | After MAD (102) | Early efficacy/biomarker signal |
| Gate 3 | After Phase 2 PoC (201) | Dose–response established → commit Phase 3 |
| Gate 4 | After Phase 3 (301) | Positive benefit–risk → submit |
Decisions and rationale are recorded in the Decision Log (PM-DECISION). Cost context per PM-003; risks per PM-004.