Responding to requests
Requests for Further Information
If there are questions during review, the reviewing organisation can raise a 'Request for Further Information' (RFI). They'll ask you to provide additional information or clarification.
RFIs are sent, as a task, to the user who initially submitted the application. Only the person that submitted the application can view and respond to an RFI. If you've applied for review, you should regularly check your account for new RFIs.
If you need more time to respond to an RFI, you can formally request an extension. To make a request, email the MHRA at clintrialhelpline@mhra.gov.uk advising how much time beyond the usual 14 days is needed. If granted, you'll submit your response to the RFI within the agreed timeframe. A final decision will be issued 10 days after your response has been received. Please be aware that an RFI extension will affect overall review timelines.
To respond to an RFI, return to 'My Tasks' - 'My Personal Tasks' and select the project. You'll then be able to review the assessor's comments and respond to their queries in the on-screen text box. Exceptionally, for example if the response is very lengthy or contains images or tables, you may provide your responses in a separate document. If this is the case, you should add a comment to the text box to confirm this. You may also need to upload additional documents, updated versions of existing documents, or information to the dataset. In this case, return to the Project Dashboard and add this information in the same way as for an initial submission. If you need to go back to the screen with the RFI text boxes, you'll need to select 'Update RFI details'.
You can then proceed to check your answers and request review. This will route the project to the Sponsor or Sponsor Delegate's account. The Sponsor or Sponsor Delegate should then review and make the final submission of the RFI back to the assessors. This will appear to the Sponsor or Sponsor Delegate under 'My Tasks' - 'My Organisational Tasks' with an outstanding task to confirm submission.
Should the assessors have further queries following the response to RFI these will be made as a request for clarification. Where these require documents to be submitted this can be done via IRAS. When a clarification request is made it will appear in the 'My Tasks' - 'My Personal Tasks' section of your IRAS account.