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  • COMBINED REVIEW: What will happen to ongoing CTIMP studies submitted in the standard system?

    In January 2022 there will be no change, and amendments and reports for these studies should continue to be submitted in the usual way.

    We will, in time, migrate ongoing CTIMPs to the new part of IRAS for amendments and other post approval activities. Once this has happened you will be able to manage your study entirely within the new part of IRAS.

    We don’t have a confirmed date for migration yet, but we will provide sponsors and applicants with full instructions and plenty of notice. In January 2022 combined review becomes the way that all new CTIMP applications are made. Migration of studies will take place at a later date.

    IMPORTANT: Any CTIMP applications you have begun in the standard part of IRAS must be submitted by 31 December 2021.

  • I have a CTIMP application still in progress in the standard part of IRAS. What do I do?

    All the required applications (REC and MHRA submissions) should be submitted for approval in the standard system before the end of December 2021 or restarted in the new part of IRAS.

    We are advising everyone with existing CTIMP or combined IMP/device trial applications currently in preparation in the standard part of IRAS to make sure that they complete and submit all their applications as soon as possible, and definitely by the end of December 2021.

    If applicants or sponsors think they will not be able to meet the December deadline, for example if they have one approval completed in the standard part of the system and one outstanding, they should contact the combined review team for advice and support cwow@hra.nhs.uk.

  • Will my CTIMP application in the standard system be affected if I have not received a decision by the end of December?

    No. The important action to take is to ensure you have completed and submitted both your REC and MHRA applications by the end of December. The study will then be migrated at a later date if it is still active, so that you will be able to make use of post-approval functionality in the new part of IRAS.

  • I am getting ready to start a new CTIMP or combined IMP/device application. What should I do?

    Applicants and sponsors should now be preparing all these applications in the new part of IRAS under the combined review service. Using combined review now will help all those involved in the submission of CTIMPs to become familiar with the process and new system ahead of 1 January 2022.

    You will not be able to start a new CTIMP application in the standard part of IRAS after 14 December 2021. From this date it will only be possible to create CTIMP applications in the new part of IRAS. Please see our other questions and answers for information about existing and approved CTIMP applications.

    The standard version of IRAS will still be available for other research types.

  • How do I make amendments to CTIMP studies approved in the standard part of IRAS?

    Amendments should continue to be made using the amendment tool and the standard amendment processes, until previously approved CTIMP studies migrate to the new parts of IRAS. The amendment tool generates the same information as Annex 2 and is accepted by the MHRA. You can find out more in IRAS Help. Amendments for combined review studies are submitted via the new part of IRAS.