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: 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=2 | ||
| | |unit=2.3.2 | ||
|scope=G | |||
|doc_part=3.1.2 - Organisation | |||
|language=EN | |||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00118-Cri-rit ++ TAG-00119-Maj-heF ++ TAG-00327-Exa-spi ++ TAG-00060-Del-ben ++ TAG-00137-Mon-che | |||
|tags_display=[[Glossary:TAG-00118-Cri-rit|Critical finding]], [[Glossary:TAG-00119-Maj-heF|Major finding]], [[Glossary:TAG-00327-Exa-spi|Examples]], [[Glossary:TAG-00060-Del-ben|Delegation]], [[Glossary:TAG-00137-Mon-che|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. | |||
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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. | |||
[...] | [...] | ||
Organisation and Personnel: | Organisation and Personnel: | ||
| Line 51: | Line 18: | ||
• The trial supervision was insufficient to ensure the timely resolution of several significant observations identified during the trial monitoring. | • The trial supervision was insufficient to ensure the timely resolution of several significant observations identified during the trial monitoring. | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:49, 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 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 |
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. [...]
