Project Risk Register — GLPI-103 Development Program
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The project risk register — the catalogue of program risks with their likelihood, impact, and mitigations.
Why it exists. Programs fail on unmanaged risks (clinical, regulatory, CMC, commercial). The register makes risks explicit and assigns owners and mitigations, and is reviewed as the program evolves.
How it is produced here. It is a program-management document: the planning, budgeting, and governance wrapper around the science — how the whole development program is run as a project.
Format & governing standard. —
Project Risk Register — GLPI-103 Development Program
| Field | Value |
|---|---|
| Document ID | PM-004 |
| Version | 1.0 |
| Status | Final (portfolio) |
| Effective Date | 2026-06-29 |
| Confidentiality | Confidential — portfolio use |
프로젝트(사업) 리스크 등록부다. 환자 안전성 리스크(Pharmacovigilance)는 별도 RMP(Phase 4)에서 다룬다. P=Probability, I=Impact (각 1–5), Score=P×I.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Project Mgmt | 초판 |
Risk Table
| ID | Category | Risk | P | I | Score | Mitigation | Owner |
|---|---|---|---|---|---|---|---|
| R-01 | Enrollment | Phase 3 느린 등록 (실측 screen-fail 43%) | 4 | 4 | 16 | 사이트 확대·디지털 모집·I/E 재검토 | Clinical Ops |
| R-02 | Cost/Budget | 초기상 과대 설계로 자본 조기 소진 | 3 | 4 | 12 | REF-002 보정 N·Phase-gate 투자(PM-003) | PM / Finance |
| R-03 | Efficacy | Phase 2 PoC에서 용량–반응 불충분 | 3 | 5 | 15 | 충분한 용량폭·바이오마커 조기 readout | Clinical / Biostat |
| R-04 | Safety | APJ 관련 심혈관/심박 신호 | 2 | 5 | 10 | 전임상 심혈관 평가·AESI 모니터링·DSMB | PV / Clinical |
| R-05 | Safety | GLP-1 계열 GI 내약성·췌장염·MTC/MEN2 | 3 | 3 | 9 | 적정용량 적정·AESI·제외기준 | PV |
| R-06 | Data integrity | CSR 수치와 TLF/통계 산출물 불일치 | 3 | 4 | 12 | reconcile_csr.py 자동 정합성 검증(Phase 1) | Biostat / DM |
| R-07 | Competition | semaglutide/tirzepatide/retatrutide 대비 차별화 실패 | 3 | 4 | 12 | 심대사·HFpEF 포지셔닝(TPP #7) | Strategy |
| R-08 | Regulatory | 다지역(FDA/EMA/MFDS/PMDA) 요구 상이 | 3 | 3 | 9 | ICH 코어 도시에 + 지역 Module 1 분기 | Regulatory |
| R-09 | Quality/CMC | 이중제형(IV+Oral) CMC 복잡성 | 3 | 3 | 9 | 조기 CMC 개발·리드 제형 우선(101) | CMC |
Top Risks (Score ≥ 12)
R-01(16) · R-03(15) · R-02·R-06·R-07(12). → Steering Committee 분기 검토.
연계
PM-001(Charter §7) · PM-003(R-02 비용) · RMP(환자 안전성, Phase 4).
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