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: 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=4 | ||
| | |unit=4.2.1 | ||
| | |scope=G | ||
| | |doc_part=5.1 - 5.2 | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00126-Cer-rte ++ TAG-00244-Def-ini ++ TAG-00149-Sig-nds ++ TAG-00150-Sou-eUr | |||
|tags_display=[[Glossary:TAG-00126-Cer-rte|Certified copy]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00149-Sig-nds|Signature]], [[Glossary:TAG-00150-Sou-eUr|Source documents]] | |||
|comment=Repeated entry: 2.1.2 ++ 4.2.1 | |||
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Certified copies: definition and verification (repeated) | Certified copies: definition and verification (repeated) | ||
| | |content=5.1. Certified copies | ||
= | |||
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 produce an exact copy having all the same information, including data that describe the context, content and structure, as the original. | 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 produce an exact copy having all the same information, including data that describe the context, content and structure, as the original. | ||
The ICH GCP guideline requires that copies (irrespective of the media used) in the eTMF that irreversibly replace originals should be certified copies of the original. Any transfer or conversion (e.g. digitisation or printing), which does not fulfil the criteria for a certified copy, is not suitable to replace an original file. | The ICH GCP guideline requires that copies (irrespective of the media used) in the eTMF that irreversibly replace originals should be certified copies of the original. Any transfer or conversion (e.g. digitisation or printing), which does not fulfil the criteria for a certified copy, is not suitable to replace an original file. | ||
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Some copies of documents in the TMF do not replace the original and therefore do not require certification (e.g. original wet-ink signed contracts held at the legal departments of the sponsor and the | Some copies of documents in the TMF do not replace the original and therefore do not require certification (e.g. original wet-ink signed contracts held at the legal departments of the sponsor and the | ||
investigator/institutions and copies in the sponsor and investigator/institution TMF; original delegation log in investigator/institution TMF and copy in sponsor TMF). The creation of such copies for a TMF should be defined in a written procedure. The procedure should ensure that the copy is of sufficient quality for the intended purpose. | investigator/institutions and copies in the sponsor and investigator/institution TMF; original delegation log in investigator/institution TMF and copy in sponsor TMF). The creation of such copies for a TMF should be defined in a written procedure. The procedure should ensure that the copy is of sufficient quality for the intended purpose. | ||
}} | |||
Latest revision as of 13:50, 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 4 — Unit 4.2.1 |
| Scope | G |
| Document part | 5.1 - 5.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Certified copy, Definition, Signature, Source documents |
Content
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 produce an exact copy having all the same information, including data that describe the context, content and structure, as the original. The ICH GCP guideline requires that copies (irrespective of the media used) in the eTMF that irreversibly replace originals should be certified copies of the original. Any transfer or conversion (e.g. digitisation or printing), which does not fulfil the criteria for a certified copy, is not suitable to replace an original file. [...] 5.2. Other copies Some copies of documents in the TMF do not replace the original and therefore do not require certification (e.g. original wet-ink signed contracts held at the legal departments of the sponsor and the investigator/institutions and copies in the sponsor and investigator/institution TMF; original delegation log in investigator/institution TMF and copy in sponsor TMF). The creation of such copies for a TMF should be defined in a written procedure. The procedure should ensure that the copy is of sufficient quality for the intended purpose.
