Reference:ICH ICH E6 Guideline R3 (2025) Appendix C 2

Document information
Reference	ICH ICH E6 Guideline R3 (2025)
Validity area	ICH
Scope(s)	HM
Document name	ICH E6 Guideline
Version / Revision	R3 (2025)
Status	Current
Document type	International guideline
Language(s)	EN
Description	GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 6 — Unit 6.3.1
Scope	G
Document part	Appendix C 2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Essential documents, Archiving, Source documents, Sponsor, Trial master file

Content

Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL [...] C.2 Management of Essential Records [...] C.2.4 The sponsor and investigator/institution should maintain a record of where essential records are located, including source records. The storage system(s) used during the trial and for archiving (irrespective of the type of media used) should provide for appropriate identification, version history, search and retrieval of trial records. [...] C.2.7 The sponsor and investigator/institution should ensure the retention of the essential records required to fulfil their responsibility. The original records should generally be retained by the responsible party who generated them. [...] C.2.9 When a copy is used to permanently replace the original essential record, the copy should fulfil the requirements for certified copies.

C.2.10 Some records are typically maintained and retained only by the sponsor (e.g., those related solely to sponsor activities such as data analysis) or only by the investigator/institution (e.g., those that contain confidential participant information). Some records may be retained by the sponsor and/or the investigator/institution. […] C.2.12 Certain essential records may not be specific to a trial but may be related to the investigational product, facilities or processes and systems, including computerised systems, involved in running multiple trials and retained outside the trial-specific repositories (e.g., Investigator’s Brochure, master services agreements, standard operating procedures, validation records).