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: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 | ||
| | |module=2 | ||
| | |unit=2.4.0 | ||
| | |scope=G | ||
| | |doc_part=2.5 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00257-Sit-zen ++ TAG-00342-Sit-der ++ TAG-00334-Tra-ngP ++ TAG-00151-Sta-rat ++ TAG-00201-Cli-eSt | |||
|tags_display=[[Glossary:TAG-00257-Sit-zen|Site staff]], [[Glossary:TAG-00342-Sit-der|Site resources]], [[Glossary:TAG-00334-Tra-ngP|Training]], [[Glossary:TAG-00151-Sta-rat|SOP]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]] | |||
|comment=Repeated entry: 4.5.2 ++ 2.4.0 | |||
| | |||
Personnel and staffing requirements during clinical investigation conduct | Personnel and staffing requirements during clinical investigation conduct | ||
| | |content=2.5. Personnel | ||
= | |||
2.5. Personnel | |||
Points to consider: | Points to consider: | ||
• SOP for minimum staffing levels during clinical conduct and medical supervision on dosing days. | • SOP for minimum staffing levels during clinical conduct and medical supervision on dosing days. | ||
| Line 52: | Line 22: | ||
• Qualification and training of permanent and temporary staff. | • Qualification and training of permanent and temporary staff. | ||
[...] | [...] | ||
}} | |||
Latest revision as of 13:49, 16 July 2026
| 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 | |
|---|---|
| Module | Module 2 — Unit 2.4.0 |
| Scope | G |
| Document part | 2.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Site staff, Site resources, Training, SOP, Clinical investigation |
Content
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. [...]
