Clinical investigations: continuing review and follow up

Annual status:

• Annual report submission procedure CEHF
• Template Annual Report Form

Pharmacovigilance

• Management of SAE/SUSAR by the CEHF
• 106-AAHRPP-FORM-018: Template Development Safety Update Report (DSUR)

New events occurring during an experiment :

• Procedure for the declaration of non compliance, deviation, violation, unexpected events occurring during an experiment
• Protocol deviation, violation, unexpected events declaration form

End of study notification

• Definition and management of end of trial's notification to CEHF
• End of experiment notification form

Update: 14.03.2023