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.