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: Difference between revisions
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Revision as of 15:06, 29 June 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 | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| 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 | G | 3 | EN | 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 ... |
| 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 3.5.2 | G | 3.5.2 | EN | 3.5.2. Superseded documents During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may require input and review by various functions. ... |
| 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 3.5.3 | G | 3.5.3 | EN | 3.5.3. Correspondence Relevant correspondence that is necessary for reconstruction of key trial conduct activities and decisions should be retained. This includes correspondence with ethics ... |
| 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 5.1 - 5.2-001 | G | 5.1 - 5.2 | EN | 5.1. Certified copies A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or has been generated through a validated process to ... |
| 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 5.1 - 5.2-002 | G | 5.1 - 5.2 | EN | 5.1. Certified copies A certified copy is a paper or electronic copy of the original document that has been verified (e.g. by a dated signature) or has been generated through a validated process to ... |
