Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - Randomisation

Document information
Reference	EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023
Validity area	EU
Scope(s)	G
Document name	EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022
Version / Revision	2023
Status	Current
Document type	Official guideline
Language(s)	EN
Description	EMA/INS/GCP/164938/2024 Inspections Office Quality and Safety of Medicines Department Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2023 Adopted by the GCP IWG on 26 November 2024
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 3 — Unit 3.3.2
Scope	G
Document part	3.1.2 - Randomisation
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Critical finding, Major finding, SUSAR, Randomisation, Examples

Content

Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Randomisation/Blinding/Codes IMP: • Accidental Suspected Unexpected Serious Adverse Reaction (SUSAR) unmasking: there were three cases where unblinding information was included in SUSAR queries / acknowledgement reports that were sent to blinded sponsor personnel and in two cases the unblinding information was subsequently forwarded to investigator sites. • Deficiencies in maintaining the integrity of the blind. • An issue in the Interactive Response Technology (IRT) system was not solved during the study. No possibility of changes in the IRT system were planned at least in the agreement with the vendor in case of issues. Only a simple communication to investigators was undertaken. [...]