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| <noinclude>{{#set:
| | {{DocumentData |
| |DocReference=EU EMA/INS/GCP/856758/ 2018
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| Guideline on the content, management and archiving of
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| the clinical trial master file (paper and/or electronic) 06-Dec-2018
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| |DocValidityArea=EU
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| |DocScopes=G
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| |DocName=EMA/INS/GCP/856758/ 2018
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| Guideline on the content, management and archiving of
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| the clinical trial master file (paper and/or electronic)
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| |DocVersion=06-Dec-2018
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| |DocStatus=Current
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| |DocType=Official guideline
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| |DocLanguage=EN
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| |DocDescription=EMA/INS/GCP/856758/2018
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| Good Clinical Practice Inspectors Working Group (GCP IWG)
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| Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)
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| |DocRestricted=No
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| |DocSubmittedBy=Florian Adragna
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| |DocContributors=
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| }}</noinclude>
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| {{DocumentBox
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| |reference=EU EMA/INS/GCP/856758/ 2018 | | |reference=EU EMA/INS/GCP/856758/ 2018 |
| Guideline on the content, management and archiving of | | Guideline on the content, management and archiving of |
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| |contributors= | | |contributors= |
| }} | | }} |
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| <noinclude>
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| == References ==
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| {| class="wikitable" style="width:100%;"
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| ! Reference !! Scope !! Document part !! Language !! Preview
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| |-
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| | [[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 ...
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| | [[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. ...
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| | [[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 ...
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| | [[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 ...
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| | [[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 ...
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| |}
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| </noinclude>
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