Submitting new documents after a positive decision on appeal

After the CCMO has issued a positive decision on the administrative appeal, the CCMO will hand over the research file for further processing to the primary reviewing accredited MREC. This means that new applications for an additional decision, such as an amendment to the protocol, must be submitted to this MREC. The same applies to other documents which result from the ongoing study, such as progress and final reports, SAEs and SUSARs.