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: Difference between revisions
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{{ | {{ReferenceData | ||
| | |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=3.5.2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00152-Tri-gat ++ TAG-00343-Doc-ten ++ TAG-00033-Pro-oto ++ TAG-00148-Con-rsc | |||
|tags_display=[[Glossary:TAG-00152-Tri-gat|Trial master file]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00148-Con-rsc|CRO]] | |||
|comment=Handling superseded documents during trial | |||
|content=3.5.2. Superseded documents | |||
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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 Superseded documents | |||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. The documentation to | 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. The documentation to | ||
demonstrate that the process was followed should be retained. Superseded versions of final documents are necessary to reconstruct the trial and should therefore be retained in the TMF. Superseded versions of sponsor-produced documents (e.g. trial protocol, IB and eCRF) should be present in the investigator/institution TMF in a manner to enable reconstruction without the need to access the sponsor TMF, with evidence of date of receipt, review and/or approval (when necessary) and date of implementation by the investigator/institution. | demonstrate that the process was followed should be retained. Superseded versions of final documents are necessary to reconstruct the trial and should therefore be retained in the TMF. Superseded versions of sponsor-produced documents (e.g. trial protocol, IB and eCRF) should be present in the investigator/institution TMF in a manner to enable reconstruction without the need to access the sponsor TMF, with evidence of date of receipt, review and/or approval (when necessary) and date of implementation by the investigator/institution. | ||
}} | |||
Latest revision as of 13:49, 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 | 3.5.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Trial master file, Documentation, Protocol, CRO |
Content
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. The documentation to demonstrate that the process was followed should be retained. Superseded versions of final documents are necessary to reconstruct the trial and should therefore be retained in the TMF. Superseded versions of sponsor-produced documents (e.g. trial protocol, IB and eCRF) should be present in the investigator/institution TMF in a manner to enable reconstruction without the need to access the sponsor TMF, with evidence of date of receipt, review and/or approval (when necessary) and date of implementation by the investigator/institution.
