Final clinical trial reports
Here you will find answers to frequently asked questions about final clinical trial reports.
Which documents are to be submitted as a final clinical trial report?
It is not necessary to submit the entire final clinical trial report; submission of the trial synopsis is sufficient. A paper version of the trial synopsis is to be submitted, however, additional electronic submission would be greatly appreciated.
Does the final clinical trial report have to be submitted to the national competent authority?
In accordance with Section 13 sub-section 9 of the GCP Ordinance (GCP-Verordnung), a summary of the clinical trial report shall be submitted to the national competent authority within a year after the end of the trial, covering all important results of the clinical trial. Submission of the synopsis of the final clinical trial report is sufficient to fulfill this requirement.
Does the final clinical trial report have to be submitted one year after completion of the clinical trial in Germany or one year after completion of the trial worldwide?
Since a final clinical trial report can only be prepared after worldwide completion of the trial, the one-year period is calculated starting from the actual date of trial completion.
How long is the sponsor obliged to keep the documents of a clinical trial?
In accordance with Section 13 sub-section 10 of the GCP Ordinance, the sponsor shall ensure that the important documents of the clinical trial, including the protocol, are kept for at least ten years after the end or termination of the trial. Other provisions concerning the keeping of medical documents shall remain unaffected.