Reference:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 3
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| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/856758/ 2018
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/856758/ 2018
Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) |
| Version / Revision | 06-Dec-2018 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/856758/2018
Good Clinical Practice Inspectors Working Group (GCP IWG) Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) |
| 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 | 3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial master file, Sponsor, Trial site, Documentation |
| Comment | TMF structure, contents and management |
Content
3. Trial master file structure and contents 3.1. Sponsor and investigator trial master file The TMF is usually composed of a sponsor TMF, held by the sponsor organisation, and an investigator TMF held by the investigator/institution. The investigator TMF is often referred to as the investigator site file (ISF). The TMF for the trial, both of the sponsor and of the investigator/institution, should be established at the beginning of the trial. [...]
