Clinical trials conducted by the TCC will require at least one of the following to report the results:

(1) Those trials which require study reports to support marketing applications are required to meet the standards of the ICH Guidance for Structure and Content of Clinical Study Reports. Each Study Report for submission to the regulatory agencies for trials conducted by the TCC will follow a Statistical Analysis Plan which will be developed in line with the ICH Topic E3 Structure and Content of Clinical Study Reports.

Regulatory reports to be submitted at the end of a trial which do not have to support marketing authorisation will take the form of a publication to a peer review journal.

(2) All trials will submit publications to peer reviewed journals which will be done in accordance with: