Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.13.1

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 5 — Unit 5.1.1
Scope	G
Document part	III. Annex 1 3.13.1
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Safety, Sponsor, Adverse event, Screening
Comment	Sponsor review and aggregation of safety information

Content

3.13.1 Sponsor Review of Safety Information The sponsor should aggregate, as appropriate, and review in a timely manner relevant safety information. This includes the review of any reported unfavourable medical events occurring in participants before investigational product administration (e.g., during screening). This may result in the update of the protocol, Investigator’s Brochure, informed consent materials and related documents. [...]