- Protocol and all supporting documentation finalised and EudraCT number generated
- Create IRAS account (if a new user). Create a new project and assign key roles (CI, Project Deputy, Sponsor Group etc)
- CI or Project Deputy completed project details, study information and clinical trial dataset in IRAS and uploads all supporting documentation
- Application is routed by the CI of Project Deputy to the sponsor or sponsor delegate organisation assigned to manage the submission for their review and authorisation CI or Project Deputy completes the REC booking task using online booking CI or Project Deputy submits application
Application submitted for combined review by REC and MHRA. Studies taking place in the NHS/HSC are also reviewed against NHS standards.
This can either lead to REC review undertaken or MHRA review undertaken. Applicants submits responses to RFIs in IRAS point to both of these, and these both point to requests for further information (RFI) issues (if required) or alternatively:
- REC review undertaken can lead to REC approval issued
- MHRA review undertaken can lead to MHRA approval
Both of the above then lead to 'For studies taking place in the NHS/HSC study-wide review completed.