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: Difference between revisions
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| | |has_document=Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 | ||
| | |module=4 | ||
| | |unit=4.3.1 | ||
| | |scope=G | ||
| | |doc_part=3.1.2 - Monitoring | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00137-Mon-che ++ TAG-00138-Rem-oni ++ TAG-00118-Cri-rit ++ TAG-00119-Maj-heF ++ TAG-00327-Exa-spi | |||
|tags_display=[[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00138-Rem-oni|Remote monitoring]], [[Glossary:TAG-00118-Cri-rit|Critical finding]], [[Glossary:TAG-00119-Maj-heF|Major finding]], [[Glossary:TAG-00327-Exa-spi|Examples]] | |||
|comment=Examples of critical and major findings in monitoring | |||
|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. | |||
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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: | Monitoring: | ||
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• 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. | • 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. | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:50, 16 July 2026
| 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 4.3.1 |
| Scope | G |
| Document part | 3.1.2 - Monitoring |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Monitoring, Remote monitoring, Critical finding, Major finding, 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. [...] 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. [...]
