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

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 4 — Unit 4.2.2
Scope	G
Document part	3.1.2 - SD
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Source documents, Critical finding, Major finding, Examples, Documentation

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. [...] Source Documentation: • The source documentation did not detail the reason for the trial participant's early termination from the trial or whether it was the trial participant's or the doctor's decision. • Diaries were not available for several trial participants. • In the trial specific binders with source data, all names of trial participants had been redacted. [...]