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

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 2 — Unit 2.3.2
Scope	G
Document part	3.1.2 - Organisation
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Critical finding, Major finding, Examples, Delegation, Monitoring
Comment	Examples of critical and major findings in trial conduct

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. [...] Organisation and Personnel: • Delegation of trial specific tasks had not been done and/or documented properly. • Insufficient resources available to perform the trial duties, including timely entry of source data in the eCRF and performance of assessments in real time. • The trial supervision was insufficient to ensure the timely resolution of several significant observations identified during the trial monitoring. [...]