Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4

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 1 — Unit 1.1.1
Scope	G
Document part	Appendix B. B4
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Study design, Endpoint, Protocol, Blinding, Randomisation, Placebo, Adaptive design, Investigational drug (IMP), Stopping rules, Drug accountability, Randomisation code, Decentralised trial

Content

B.4 Trial Design The scientific integrity of the trial and the reliability of the results from the trial substantially depend on the trial design. A description of the trial design should include: B.4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial. B.4.2 A description of the type and design of trial to be conducted (e.g., double-blind, placebo-controlled, parallel design, adaptive design, platform/umbrella/basket, trials with decentralised elements) and a schematic diagram of trial design, procedures and stages. B.4.3 A description of the measures taken to minimise/avoid bias, including:

   (a) Randomisation
   (b) Blinding

B.4.4 A description of the investigational product(s) and the dosage and dosage regimen of the investigational product(s), including a description of the dosage form, packaging and labelling. B.4.5 Preparation (e.g., reconstitution) and administration instructions where applicable, unless described elsewhere. B.4.6 A description of the schedule of events (e.g., trial visits, interventions and assessments). B.4.7 The expected duration of the participant’s involvement in the trial and a description of the sequence and duration of all trial periods, including follow-up, if any. B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for individual participants, for parts of the trial or for the entire trial. B.4.9 Accountability procedures for the investigational product(s), including the placebo(s) and other comparator(s), if any. B.4.10 Maintenance of treatment randomisation codes and procedures for breaking codes.