Reference:ICH ICH E6 Guideline R3 (2025) Appendix C-002

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 2 — Unit 2.1.5
Scope	G
Document part	Appendix C
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Essential documents, Trial master file, Documentation, Study design
Comment	Repeated entry: 2.1.1 ++ 2.1.5 Essential records for clinical trial conduct: sponsor/investigator file

Content

Appendix C. ESSENTIAL RECORDS FOR THE CONDUCT OF A CLINICAL TRIAL C.1 Introduction C.1.1 Many records are generated before and during the conduct of a clinical trial. The nature and extent of those records generated and maintained are dependent on the trial design, its conduct, application of risk proportionate approaches and the importance and relevance of that record to the trial.

C.1.2 Determining which records are essential will be based on consideration of the guidance in this appendix.

C.1.3 The essential records permit and contribute to the evaluation of the conduct of a trial in relation to the compliance of the investigator and sponsor with Good Clinical Practice (GCP) and applicable regulatory requirements and the reliability of the results produced. The essential records are used as part of the investigator oversight and sponsor oversight (including monitoring) of the trial. These records are used by the sponsor’s independent audit function and during inspections by regulatory authority(ies) to assess the trial conduct and the reliability of the trial results. Certain essential records may also be reviewed by the institutional review board/independent ethics committee (IRB/IEC) in accordance with applicable regulatory requirements. The investigator/institution should have access to and the ability to maintain the essential records generated by the investigator/institution before and during the conduct of the trial and retain them in accordance with applicable regulatory requirements.

C.2 Management of Essential Records [...] C.3 Essentiality of Trial Records C.3.1 The assessment of whether a record is essential and has to be retained should take into account the criteria below. […] Essential Records Table [...]