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

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	3.5.3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Correspondence as essential trial documentation

Content

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 committees, data safety monitoring committee and regulatory authorities (confirming sponsor approval of processes, documents and decisions and the communication regarding issues that arise in the trial conduct and how they are dealt with). Similarly, electronic correspondence (e-mails and associated attachments between CROs, sponsor departments, investigator/institution) should be readily available and may be retained electronically. It should be ensured that both sent and received correspondence is filed in the TMF. One or more separate central repository may be used (e.g. for e-mail), as long as they are clearly defined as being part of the TMF (see section 3.2). Care should be taken regarding e-mail ‘chains’ and attachments to ensure that relevant strands of conversations and their associated documents are maintained. For archiving of correspondence see section 6.3.