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

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

References

	Scope	Document part	Language	Preview
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 …
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 Superseded documents During a document’s development (e.g. clinical trial protocol development and release), the sponsor’s/CRO’s procedures may…
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. T…
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 ha…
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 ha…