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: Difference between revisions
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{{:Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022}} | {{: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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! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
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| G | | G | ||
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! | ! Document part | ||
| 2.9 | | 2.9 | ||
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! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
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! | ! Contributors | ||
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! | ! Tags (EN) | ||
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! | ! Tags (original language) | ||
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! | ! Comment | ||
| Recruitment and consent: key considerations | | Recruitment and consent: key considerations | ||
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== | == Content == | ||
2.9. Recruitment and consent | 2.9. Recruitment and consent | ||
Points to consider: | Points to consider: | ||
Revision as of 14:27, 29 June 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 | |
|---|---|
| Scope | G |
| Document part | 2.9 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Recruitment and consent: key considerations |
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).
