Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComCompliance: 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=4.1.3 | ||
| | |scope=G | ||
| | |doc_part=3.1.2 - ComCompliance | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00118-Cri-rit ++ TAG-00119-Maj-heF ++ TAG-00143-Non-abw ++ TAG-00327-Exa-spi ++ TAG-00137-Mon-che | |||
|tags_display=[[Glossary:TAG-00118-Cri-rit|Critical finding]], [[Glossary:TAG-00119-Maj-heF|Major finding]], [[Glossary:TAG-00143-Non-abw|Protocol deviation]], [[Glossary:TAG-00327-Exa-spi|Examples]], [[Glossary:TAG-00137-Mon-che|Monitoring]] | |||
|comment=Examples of critical and major compliance findings | |||
|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. | |||
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Investigational Site | Investigational Site | ||
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• A patient was considered eligible while failing one exclusion criterion. Although the examination performed on randomisation day met the acceptance criteria, the patient should have been considered a screen failure considering that rescreening was not allowed in this trial. | • A patient was considered eligible while failing one exclusion criterion. Although the examination performed on randomisation day met the acceptance criteria, the patient should have been considered a screen failure considering that rescreening was not allowed in this trial. | ||
[...] | [...] | ||
}} | |||
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 4.1.3 |
| Scope | G |
| Document part | 3.1.2 - ComCompliance |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Critical finding, Major finding, Protocol deviation, Examples, 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. [...] Investigational Site
Protocol Compliance (Others) • Appropriate measures were not taken to keep the investigator personnel blinded to trial participant treatment assignment. • Not all investigations/trial visits for trial participants were performed as specified in the trial protocol. • Treatment of a trial participant with prohibited medication.
Protocol Compliance (Safety Reporting) • Reporting of serious adverse events not done within the 24-hour timeline. • Classification of "life threatening" adverse event as non-serious. • Several potential adverse events collected by the clinical nurses or by oncologist residents in the electronic medical records were not collected, assessed or reported in the trial eCRF.
Protocol Compliance (Selection Criteria) • Inclusion of trial participants not meeting eligibility criteria. • A patient was considered eligible while failing one exclusion criterion. Although the examination performed on randomisation day met the acceptance criteria, the patient should have been considered a screen failure considering that rescreening was not allowed in this trial. [...]
