CAEndOfTrial object
End of trial declaration mandatory for
All clinical trials requiring authorisation by CA
Responsible for End of trial declaration
Sponsor
Principal Investigator
Regular Termination - Declaration timespan (max nr days)
90
Early/premature Termination - Declaration timespan (max nr days)
15
Reasons for early termination shall be clearly stated
Yes
Additional Information
According to §42 b AMG, within a year after the end of the clinical trial, the sponsor shall send the CA and the competent EC a summary of the report on the clinical trial, covering all important results of the clinical trial. The report should be submitted electronically via the Drug Information Portal of the Bund (Federal Government) and the Laender (States).