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
From GxPlex
| 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 3 — Unit 3.2.1 |
| Scope | G |
| Document part | 2.9 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Enrolment, Informed consent, Screening, Undue inducement |
Content
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 participant’s primary physician/family doctor. • Procedures to prevent ‘over-volunteering’. • Routine screening procedure (including any counselling or procedures for handling reportable diseases e.g. for positive serology results). • Trial participant records. • Procedures taken to verify the identity of the trial participants. Procedures for payment. • Procedures for taking consent (including verification that trial participants have understood the information).
