IRAS user guide

Developmental Safety Update Reports (DSUR)

DSURs for trials submitted using combined review must be submitted within new IRAS. One submission can cover multiple projects. More details on how to submit bulk uploads are given below. Combined review applications should not submit their DSURs through the MHRA's Medicines Portal.

Before you submit your DSUR for a trial submitted via combined review you'll first need to pay the assessment fee to the MHRA. Once paid the MHRA will send you a receipt which you'll need to include in your DSUR submission.

To submit your DSUR in new IRAS you should go to 'My Studies - My Projects' and open the project you wish to submit a report for.

Select the 'Reporting' button from the top right side of the screen.

You should then select the type of report you wish to make from the drop-down list. In this case select the 'DSUR' option.

The following page will be automatically populated with the project's IRAS ID and EudraCT number (if previously provided).

You should then enter the details of the applicant submitting the report, and upload supporting documents. You'll need to attach at least one cover letter, a copy of your receipt for the assessment fee (uploading this as a 'Cover letter' document type in new IRAS) in addition to the DSUR report itself. 

To maintain confidentiality, once uploaded you will not be able to download the DSUR report, cover letters or investigational medical product dossier (IMPD). Once uploaded, if you need to change one of these documents before submitting your report, you'll need to delete the document in IRAS and re-upload it once amended.

Bulk upload: Where at least one project was submitted for combined review, you can add multiple projects to your report. This can also include CTIMPs not submitted via combined review. This avoids the need to make a separate report for each project. If you're doing this, you must take care not to duplicate any IRAS IDs on this page. If the report contains any duplicate IRAS IDs, it will be rejected by the system and you'll need to go back and prepare a new DSUR from scratch. When entering additional IDs to include in the report, do not include the ID of the project you're submitting from as this will count as a duplicate.

If you enter the IRAS ID of any project which has not yet received an 'Authorised' status, the submission will be automatically rejected and you'll need to go back and prepare a new DSUR from scratch.

After submission you'll find a record of the DSUR under 'Project History' on the project details page. You can check here to confirm the status of your submission (pending / invalidated / completed etc). You can also see details of any requests for further information (INRFI) - these will also flag up as clarification requests under 'My Tasks'.