Reference:ICH ICH E6 Guideline R3 (2025) Appendix C C.2.3
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| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 2 â Unit 2.1.2 |
| Scope | G |
| Document part | Appendix C
C.2.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial master file, Essential documents, Sponsor, Trial site |
| Comment | Essential records: location and purpose of TMF and ISF |
Content
These essential records should be maintained in or referred to from repositories held by the sponsor and by the investigator/institution for their respective records. These repositories may be referred to as a trial master file (TMF). The repository held by the investigator/institution may also be referred to as the investigator site file (ISF).
