Reporting during research
During your project you'll need to submit various reports, some of which are completed in IRAS.
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.
Once created, reports can be accessed and edited from the 'Reporting' menu option, not My Tasks or My Organisational Tasks
You will then select the type of report you wish to make from the following options:
- Development Safety Update Reports (DSUR) - visit the DSUR page for more information
- Urgent Safety Measures (USM) - described below
- End of Trial (EOT) - visit the Notifying end of research page for more information
- Final report - visit the Final report page for further information
If any other report types apply to your project that are not listed above, these should be prepared and submitted outside the system. For example, you should continue to submit Suspected Unexpected Serious Adverse Reactions (SUSARs) and annual progress reports outside of the system. Visit the HRA webpages for further details on safety reporting and progress reports.
If you wish to view a submitted report, navigate to the project via 'My Projects' or 'My Organisations Projects'. For all reports (apart from the Final report) you should then select the report from the 'Project History'. To view the Final report, navigate to the project as before but select 'Reporting' - 'Final report'.
Urgent Safety Measures (USM)
Visit the MHRA's webpage for detailed instructions on reporting USMs . Notification of Urgent Safety Measures should be submitted to the MHRA via IRAS.
The process for completing an USM notification in IRAS, including bulk upload if required, is the same as for DSURs. Visit DSUR page for more information. As with DSURs, once uploaded to IRAS, certain document types will not be available to download. If you need to change one of these documents before submitting your report, you will need to delete the document in IRAS and re-upload it once amended.
The outcome of the USM is issued by the MHRA via email and will also be available to view in IRAS. If your USM is accepted, you will then be able to submit a substantial amendment, identifying that the amendment is linked to an agreed USM.
USMs do not need to be reported separately to the REC.