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Long description

Pre-submission

  • Protocol and supporting documents finalised
  • New users create IRAS account. Create a new project and allocate roles as required
  • Complete project details, study information and clinical trial dataset in IRAS and upload supporting documentation
  • Application is sent to the sponsor assigned in step two to review and authorise
  • Book a REC online and submit application

Post-submission

Application submitted for combined review by REC and MHRA. Studies take place in the NHS/HSC are also reviewed against NHS standards

Arrows show that REC review and MHRA review then take place at the same time. Either review can lead to a request for further information (RFI) (if required). From this, arrows show that the applicant submits responses to RFIs in IRAS which then feedback into each review in a circular process, or alternatively:

  • REC review can lead to REC approval issued
  • MHRA review can lead to MHRA approval

Both of the above then lead to 'For studies taking place in the NHS/HSC study-wide review completed.

Back to step by step guide to using iras for combined review