The present document provides CT sponsors with the operational guidance they need to submit ASRs through the New Safety Module on ASR, including responding to the relevant Requests for Information (RFI).
It is foreseen that this module will be integrated in the Clinical Trial Information System (CTIS). During the two months before this date, the New Safety Module on ASR is implemented in the CTIS training environment: sponsors and authority users can train themselves through using the Sponsor CTIS training environment and Member State CTIS
training environment. To request access to the CTIS training environment, refer to section 6.2.3. of the Sponsor Handbook. Once access is granted, Sponsors can refer to the present document for detailed instructions on how to operate within the module.