Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SD: 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=4.2.2 | ||
| | |scope=G | ||
| | |doc_part=3.1.2 - SD | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00150-Sou-eUr ++ TAG-00118-Cri-rit ++ TAG-00119-Maj-heF ++ TAG-00327-Exa-spi ++ TAG-00343-Doc-ten | |||
|tags_display=[[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00118-Cri-rit|Critical finding]], [[Glossary:TAG-00119-Maj-heF|Major finding]], [[Glossary:TAG-00327-Exa-spi|Examples]], [[Glossary:TAG-00343-Doc-ten|Documentation]] | |||
|comment=Examples of critical and major findings in documentation | |||
|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. | |||
[...] | [...] | ||
Source Documentation: | Source Documentation: | ||
| Line 48: | Line 18: | ||
• In the trial specific binders with source data, all names of trial participants had been redacted. | • In the trial specific binders with source data, all names of trial participants had been redacted. | ||
[...] | [...] | ||
}} | |||
Revision as of 12:55, 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 4.2.2 |
| Scope | G |
| Document part | 3.1.2 - SD |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Source documents, Critical finding, Major finding, Examples, Documentation |
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. [...] Source Documentation: • The source documentation did not detail the reason for the trial participant's early termination from the trial or whether it was the trial participant's or the doctor's decision. • Diaries were not available for several trial participants. • In the trial specific binders with source data, all names of trial participants had been redacted. [...]
