Annual Safety Report
The annual safety report (ASR, Development Safety Update Report, DSUR) should be submitted to a dedicated protected part of CTIS from start of the clinical trial in any MSC untill the end of the last clinical trial conducted by the sponsor with the IMP. The ASR will not be published in the public part of CTIS.
An ASR should be provided per IMP of a combination IMP. In some cases a single ASR for the trial may be prepared for multi-drug therapy. See also section 2.5 of the ICH E2F.
A separate ASR of the AxMPs is not required. However, any information relating to (authorised or non-authorised) AxMPs which are relevant to the IMP may be included in the ASR of the IMP. All SARs to the non-authorised AxMP(s) should be in the line listings of SARs in the ASR of the IMP(s) of the clinical trial.
Submission of an ASR is not required in case the sponsor is conducting only a single short trial less than one year long with the IMP. Sponsors need to submit an ASR also for IMPs investigated in Phase IV, low intervention trials and long-term follow-up trials.
If all trials with the IMP are on hold for over 1 year, the sponsor may submit a simplified ASR.
See also Question 7 of the Q&A on CTR.
Guideline
Details on the ASR are available in the ICH Guideline E2F – Development Safety Update Report (DSUR).
Template
Non-commercial sponsors conducting a single clinical trial on IMPs with a marketing authorisation in any of the EU/EEA member states and where the SmPC is used as RSI, can submit a simplified ASR based on the ICH-E2F. There is a template available that gives detailed instructions on what information is expected and what may be omitted in this setting. The simplified ASR should always be written in English.