Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10

Document Information

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

Scope	G
Document part	III. Annex 1 2.12.10
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Computerised systems requirements for investigators

Text

2.12.10 When using computerised systems in a clinical trial, the investigator/institution should do the following:

(a)For systems deployed by the investigator/institution, ensure that appropriate individuals have secure and attributable access;

(b)For systems deployed by the sponsor, notify the sponsor when access permissions need to be changed or revoked from an individual;

(c)For systems deployed by the investigator/institution specifically for the purposes of clinical trials, ensure that the requirements for computerised systems in section 4 are addressed proportionate to the risks to participants and to the importance of the data;

(d)Where equipment for data acquisition is provided to trial participants by the investigator, ensure that traceability is maintained and that participants are provided with appropriate training;

(e)Ensure that incidents in the use and operation of computerised systems, which in the investigator’s/institution’s judgement may have a significant and/or persistent impact on the trial data or system security, are reported to the sponsor and, where applicable, to the IRB/IEC.