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

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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

Reference Details

Scope	G
Document part	2.9
Language	EN
Original entry by	Florian Adragna
Contributors
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Tags (FR)
Comment	Recruitment and consent: key considerations

Text

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).