Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022

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. […]