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

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
Scope	G
Document part	3.5.2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Handling superseded documents during trial

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 Superseded documents During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may require input and review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 Superseded versions of final documents are necessary to reconstruct the trial and should therefore be retained in the TMF. Superseded versions of sponsor-produced documents (e.g. trial protocol, IB and eCRF) should be present in the investigator/institution TMF in a manner to enable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.