Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15

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 3 — Unit 3.3.1
Scope	G
Document part	III. Annex 1 3.15
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Blinding, Investigational drug (IMP), Sponsor, Unblinding
Comment	Blinded trials: sponsor procedures for IMP management

Content

3.15 Investigational Product(s) [...] (d) In blinded trials, the sponsor should implement:

  (i) A process to blind individuals, including the sponsor staff, trial participant, investigator and/or investigator site staff, as appropriate, to the investigational product identity and assignment, and a process to prevent and detect inappropriate unblinding;
  (ii) A procedure and mechanism that permits the investigator to rapidly identify the product(s) in case of a medical emergency where unblinding is considered necessary, while protecting the identity of the treatment assignment of the other trial participants;
  (iii) A mechanism that protects the blinding of the trial where a participant’s treatment assignment is unblinded for the purpose of safety reporting to regulatory authorities and/or IRB/IEC, where appropriate.