17-19 November 2020
The MHRA has recently made available a short format Development Safety Update Report (DSUR) form for sponsors of individual clinical trials authorized under the Notification Scheme (Type A trials). According to the agency, this is possible since "not all trials are the same in terms of risk and many trials are conducted on already marketed and well-known drugs, with minimal intervention, and closely align with normal clinical practice".
The substantially simpler and shorter form, the Health Research Authority Annual Progress Report form, may be submitted in lieu of a full DSUR providing a significant time saving. However, this is not suitable for trials which are part of a multi-study development program and the full DSUR will still be required for these, the agency says.
When submitting the annual report, it should be indicated in the cover letter that this is an Annual Progress Report (APR) in lieu of a full DSUR. The cover letter should contain the EudraCT number and CTA reference number. In addition, a list of all Serious Adverse Reactions should be included in section 6 (Safety reports) of the APR.
More information can be found on the MHRA blog Short format Development Safety Update Report (DSUR) for Type A trials.