Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6: Difference between revisions
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| | |RefTags=TAG-00032-Inf-ngs ++ TAG-00343-Doc-ten ++ TAG-00150-Sou-eUr ++ TAG-00112-Ass-nve ++ TAG-00029-Inf-rte | ||
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| Module 3 — Unit 3.1.1 | |||
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| | | [[Glossary:TAG-00032-Inf-ngs|Consent process]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00112-Ass-nve|Assent]], [[Glossary:TAG-00029-Inf-rte|Informed consent]] | ||
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Revision as of 17:29, 15 July 2026
| Document information | |
|---|---|
| Reference | EU EMA/INS/GCP/143492/2022
- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/INS/GCP/143492/2022
- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE |
| Version / Revision | 2022 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/INS/GCP/143492/2022
Good Clinical Practice Inspectors Working Group (GCP IWG) ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.1.1 |
| Scope | G |
| Document part | Page 6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Consent process, Documentation, Source documents, Assent, Informed consent |
| Comment | Need of documentation of the Informed Consent Process in Source records |
Content
[…] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric assent and emergency consent, if applicable. […]
