Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution

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 4 — Unit 4.2.3
Scope	G
Document part	III. Annex 1 3.16.1 For systems used or deployed by the investigator/institution
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Data integrity, Systems validation, Real-world evidence, Audit trail, Investigator responsibilities

Content

3.16 Data and Records 3.16.1 Data Handling [...] For systems used or deployed by the investigator/institution: [...] (vii) In situations where clinical practice computerised systems are being considered for use in clinical trials (e.g., electronic health records or imaging systems used or deployed by the investigator/institution), these systems should be assessed for their fitness for purpose in the context of the trial;

(viii) The assessment should be performed before being used in the trial and should be proportionate to the importance of the data managed in the system. Factors such as data security (including measures for backup), user management and audit trails, which help ensure the protection of confidentiality and integrity of the trial data, should be considered as appropriate;