Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.4.5.3

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 3.4.2
Scope	G
Document part	III. Annex 1 3.11.4.5.3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Monitoring, IMP storage, Drug accountability, Expiry date, Investigational drug (IMP)

Content

3.11.4.5.3 Monitoring of Investigational Product Management (a) Confirming, for the investigational product(s):

  (i) That storage conditions are acceptable and in accordance with the storage requirements specified in the protocol or other relevant documents;
  (ii) That supplies are sufficient throughout the trial and are used within their shelf life;
  (iii) That the correct investigational product(s) are supplied only to participants who are eligible to receive it at the protocol-specified dose(s) and, where appropriate, in accordance with the randomisation procedures;
  (iv) That the participants, investigator, investigator site staff and other relevant parties and individuals involved in the trial conduct are provided with necessary instruction on properly storing, using, handling, returning and destroying, or alternative disposition of the investigational product(s);
  (v) That the receipt, storage, use, handling, return and destruction or alternative disposition of the investigational product(s) are controlled and documented adequately;
  (vi) That the disposition of unused investigational product(s) complies with applicable regulatory requirement(s) and is in accordance with the sponsor requirements;
  (vii) Where product available on the market is dispensed and used in accordance with applicable regulatory requirements, some of the previously outlined considerations may not be applicable.