Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001
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Document Information
| Document information | |
|---|---|
| Reference | EU EMA/786433/2022
Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/786433/2022
Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units |
| Version / Revision | 15-Nov-2022 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/786433/2022
Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
Reference Details
| Scope | G |
|---|---|
| Document part | 2.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Repeated entry: 4.5.2 ++ 2.4.0
Personnel and staffing requirements during clinical investigation conduct |
Text
2.5. Personnel Points to consider: • SOP for minimum staffing levels during clinical conduct and medical supervision on dosing days. […] • Basic, immediate and advanced life support training. • Qualifications of the Investigators (including any experience or post graduate qualifications in human or clinical pharmacology for FIH trials). • Qualification and training of permanent and temporary staff. [...]
