Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022
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| 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 | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| 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 | G | 2.5 | EN | 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. • ... |
| Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9 | G | 2.9 | EN | 2.9. Recruitment and consent Points to consider: • Recruitment strategies. • Volunteer database. • Collection and verification of the trial participants medical history. • Contact with the trial ... |
| Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002 | G | 2.5 | EN | 2.5. Personnel Points to consider: […] • Relationship of the Investigator with the Sponsor company. […] |
