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

Document Information

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

Scope	G
Document part	3.1.2 - Monitoring
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (original language)
Tags (FR)
Comment	Examples of critical and major findings in monitoring

Text

Examples of critical and major findings in the sub-categories of the three main categories "General", "Trial Management", and "Investigational Site" are listed below. [...] Monitoring: • The process in place to allow for remote monitoring visits to be performed by the CRA was not GCP compliant as the protection of the privacy of the trial participants was insufficiently ensured. • Lack of a monitoring plan. • There was no evidence provided to inspectors that the monitoring issues identified at the sites were escalated in a timely manner. There was no evidence for continuous and effective medical monitoring activities. [...]