Long description for Phase 1 application process

Last updated on 16 Feb 2022
  • Complete your combined REC and MHRA application
  • Book your REC meeting. For Phase 1 applications, either book your REC meeting using the online booking tool in IRAS at the point of submission or reserve a meeting slot in advance by emailing your chosen REC. REC details can be found on this page
  • Submit your application. Many RECs will accept the submission of Phase 1 applications up to 7 days before the REC meeting date - this must be confirmed before submission.  Please discuss this option with your chosen REC when reserving a REC meeting slot. Day 0 is the day the application is received, except where you choose a REC meeting that is not the first available slot when you submit your application. In this scenario, day 0 is 14 days before the REC meeting date. For applications submitted 7 days before the REC meeting, day 0 is the date of submission.
  • REC Meeting and MHRA assessment. The MHRA aims to complete the initial assessment within 14 days of receipt, however the combined assessment is issued together once both MHRA and REC assessments are completed. This ensures reviews are co-ordinated and a consolidated initial outcome is agreed between the two regulators.
  • Consolidated initial outcome. The co-ordinated initial outcome from the MHRA and REC will be issued together within seven days of the REC meeting
  • Response to any Requests for Further Information (RFI) requested by the MHRA and/or REC. You are expected to respond to all RFIs within 14 days.  If you need more time, you can request an extension before the response deadline via clintrialhelpline@mhra.gov.uk
  • Final outcome. The aim is for the combined final outcome to be issued within 10 days following receipt of the RFI response.
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