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: Difference between revisions
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| | |has_document=Document: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 | ||
| | |module=2 | ||
| | |unit=2.1.2 | ||
| | |scope=G | ||
| | |doc_part=3 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00152-Tri-gat ++ TAG-00017-Spo-die ++ TAG-00135-Inv-ntr ++ TAG-00343-Doc-ten | |||
|tags_display=[[Glossary:TAG-00152-Tri-gat|Trial master file]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00135-Inv-ntr|Trial site]], [[Glossary:TAG-00343-Doc-ten|Documentation]] | |||
|comment=TMF structure, contents and management | |||
|content=3. Trial master file structure and contents | |||
| | |||
| | |||
= | |||
3. Trial master file structure and contents | |||
3.1. Sponsor and investigator trial master file | 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. | 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. | ||
[...] | [...] | ||
}} | |||
Revision as of 12:55, 16 July 2026
| 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 — 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 |
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. [...]
