View source for 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

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{{: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}}

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! colspan="2" class="gplx-infobox-header" | Reference Details
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! Scope
| G
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! Document part
| 5.1  - 5.2
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Contributors
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! Tags (EN)
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! Tags (original language)
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! Tags (FR)
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! Comment
| Repeated entry: 2.1.2 ++ 4.2.1

Certified copies: definition and verification (repeated)
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== 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.