Trial Master File (TMF) — Index
| Field | Value |
|---|---|
| Document ID | TMF-IDX |
| Version | 1.0 |
| Study No. | GLPI103-301 |
| Standard | TMF Reference Model (conceptual); ICH E6(R3) essential documents |
| Confidentiality | Confidential — TMF |
The TMF holds the essential documents that demonstrate the trial was conducted per GCP. These are internal/operational and are not eCTD submission leaves (some, e.g., aCRF/CRF, are referenced in Module 5).
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical Operations | Initial TMF index |
Essential Documents (this project)
| Doc ID | Document | Status |
|---|---|---|
| TMF-ICF | Informed Consent Form | ✅ |
| TMF-DMP | Data Management Plan (full v2.0 — edit-check spec, coding, lock) | ✅ |
| TMF-CMP | Clinical Monitoring Plan (full v2.0 — RBM, KRIs/QTLs, SDV) | ✅ |
| TMF-DSMB | DSMB Charter (full v2.0) | ✅ |
| TMF-DSMB-MIN | DSMB Meeting Minutes (summary) | ✅ |
| TMF-RAND | Randomization & IWRS Specification + UAT (full v2.0) | ✅ |
| TMF-SMP | Safety Management Plan | ✅ |
| TMF-PHARM | Pharmacy / IMP Manual | ✅ |
| TMF-LAB | Central Laboratory Manual | ✅ |
| TMF-CTA | Clinical Trial Agreement & IRB/IEC Tracker | ✅ |
| ACRF-301 / CRF-301 | Annotated CRF / Blank CRF (also Module 5) | ✅ |
| PROT-301 / SAP-301 | Protocol / SAP (also Module 5) | ✅ |
See also Quality (quality/) and Project Management (program-management/).