Samples / GLPI-103 / quality/QA-004_decision_log.md

Decision & Action-Item Log — GLPI-103 Program

Field	Value
Document ID	PM-DECISION
Version	1.0
Standard	Project governance (audit trail)
Confidentiality	Confidential

Records key governance decisions and their rationale (complements PM-004 Risk Register and QA-ISSUE).

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Project Management	Initial log

Decision Log

ID	Date	Decision	Rationale	Owner
DEC-001	2026-06-29	Document actual enrollment (900), not planned 900	Realistic under-enrollment; honest reporting	RA/Biostat
DEC-002	2026-06-29	Right-size early-phase N (SAD 40 / MAD 40 / Ph2 240)	Early-phase N driven by dose-levels×cohort, not power; cost/ethics (PM-003)	Clinical/PM
DEC-003	2026-06-29	Ground demographics in Nemotron-Personas-Korea + T2DM prevalence	Realistic Korean T2DM population	Biostat
DEC-004	2026-06-29	Map Korean SC values to English CDISC CT	XPORT encoding + submission standard	DM
DEC-005	2026-06-29	No REMS for FDA; labeling-based risk management	Class precedent; risks manageable by labeling	RA-US/PV
DEC-006	2026-06-29	Substitute subset CDISC validator for headless Pinnacle 21	P21 registration-gated GUI; honest alternative + manual steps	DM/QA

Action Items

ID	Action	Owner	Due	Status
ACT-001	Run official Pinnacle 21 and append report (SDRG §6)	DM	TBD	Open
ACT-002	Populate M4 nonclinical study reports beyond stubs	Nonclinical	TBD	Open