The announcements and reports which need to be sent to IMCA during the trial and post-trial are:

• Suspected unexpected serious adverse reactions SUSARs
• Annual Safety Report
• Declaration of finalisation of the trial (within 90 days from formal end of the trial)
• Final report, within a year from the end of the trial

Annual Report

In the event of the trial being conducted for longer than a year an Annual Report shall be submitted to IMCA which covers:

• Risk/benefit analysis of the safety of participants in the trial
• A line listing of all suspected serious adverse reactions (including unexpected ones, SUSARs) occurring during the clinical trial, including serious adverse reactions from states outside the European Economic Area (EEA)
• Summary in tabular form of suspected serious adverse reactions occurring during the trial

See further requirements on implementing the Annual Report in ”Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (Eudralex 10)”

Declaring the finalisation of the trial

Annexed to the declaration of the finalisation of the trial there need be EudraCT number and Protocol number of the sponsor. A particular form, Declaration of the End of Trial Form, should be filled in and sent to IMCA.

Final Report

A final report shall be sent to IMCA no later than a year after the end of the trial. It shall contain a brief summary of major results and their assessment along with a summary of all adverse events.