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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: Difference between revisions

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Annex V – to guidance for the conduct of good clinical practice inspections – Phase I
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== References ==
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! Reference !! Scope !! Document part !! Language !! Preview
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| [[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. […]
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Latest revision as of 14:15, 16 July 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

References

 ScopeDocument partLanguagePreview
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001G2.5EN2.5. Personnel

Points to consider: • SOP for minimum staffing levels during clinical conduct and medical supervision on dosing days. […]

• Basic, imme…
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002G2.5EN2.5. Personnel

Points to consider: […] • Relationship of the Investigator with the Sponsor company.

[…]…
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9G2.9EN2.9. Recruitment and consent

Points to consider: • Recruitment strategies. • Volunteer database.

• Collection and verification of the trial participan…
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