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Combined review applications



Combined review applications requiring information from the standard part of IRAS



This page is for researchers using the combined review service in the new part of IRAS. Due to the ongoing development of IRAS, certain types of applications will need information to be completed in both new and standard parts of IRAS as an interim measure. This applies to studies involving ionising radiation or an investigational medical device. If your study falls into either or both categories, please read the detailed instructions below which explain how to complete your application.

If, after reviewing this page you still have questions regarding your combined review application, please contact service.desk@hra.nhs.uk.



Contents



Combined Review applications involving ionising radiation.

These instructions are for applicants who are submitting through the combined review process and have a study involving ionising radiation. This guidance is in place as an interim solution until an ionising radiation module is developed and released in the new part of IRAS.



Radiation Assurance for combined review applicants.

Radiation Assurance is a pre-submission process and occurs before your application is made for other regulatory approvals such as REC and ARSAC reviews.

Combined review applicants requiring Radiation Assurance should ensure they have reviewed the guidance available on the HRA website prior to starting their application.



Instructions for generating the ‘Ionising radiation for combined review form’ in standard IRAS, and how to include the form in your combined review application.

  1. Currently, combined review applications involving the use of ionising radiation also need to include information from the standard part of IRAS in their submission. To generate the required information you should create a new project in standard IRAS and complete the project filter questions.


    • For Filter question 2, applications for Clinical Trials of Investigational Medicinal Products (CTIMPs) should select the first option; ‘Ionising Radiation for combined review of clinical trial of investigational medicinal product’. IMP/Device Trial applications should select the second option; ‘Ionising Radiation and Devices form for combined review of combined trial of an investigational medicinal product and an investigational medicinal device’

    • For Filter question 2e (CTIMPs) or Filter question 2d (IMP/Device trials) applicants should select yes to the question ‘Does the study involve the use of any ionising radiation’. Enter your combined review IRAS ID. You should also ensure that you answer the subsequent question about exposure to radioactive materials.

    • For filter question 4, applicants should select the ‘Ionising radiation for combined review form’


  2. Once you have completed the project filter questions, from the navigation page, you should select the ‘Ionising radiation for combined review form’. You should only complete section B Part 3 of this form and obtain both Clinical Radiation Expert (CRE) and Medical Physics Expert (MPE) authorisations (Unless your project also involves the use of radioactive materials, if this applies please see below.

    Applications that also involve the administration of radioactive substances.

  3. For projects involving radioactive materials an ARSAC Form will be generated. Combined review applications will need to complete the following sections of the ‘Ionising radiation for combined review form’ that display in the ARSAC PRA form:

    • Part A:A1, A3-2, A4, A6-1, A6-2, A10, A11, A12, A13, A19, A59, A60, A64-1
    • Part B Section 3
    • Part C (Research Sites)
    • Part D2 (Declaration by the sponsor's representative)

    Projects involving radioactive materials must also make an application to ARSAC. Applications to ARSAC should continue to follow the usual process.

  4. Once Part B Section 3 has been completed electronic authorisation obtained from the Lead CRE and Lead MPE. You should then download a PDF copy of this form by following the instructions on the submission tab. Selecting the ‘proceed to submission’ button will not submit the form electronically. Instead, it will generate a pdf file of the form. This can then be included as a supporting document as part of your combined review submission.


  5. Uploading the ‘Ionising radiation for combined review form’ into the combined review application. In the new part IRAS, the PDF file of the form should be uploaded to your combined review application as a supporting document. Please select "Miscellaneous: non MHRA only” as the document type when uploading the file.

    For more general instructions on creating an application in combined review please see our step-by-step user guide.


Please note: The IRAS ID generated in standard IRAS is only for the purposes of generating this form. The ID generated in the new part of IRAS and associated with your combined review application should be the one used as the project identifier (this will appear as a P-number).


Making changes to the ‘Ionising radiation for combined review form’

If changes need to be made to the ‘Ionising radiation for combined review form’, for example as part of an amendment or Request for Further Information (RFI), the applicant can log into standard IRAS, select the project and amend the information in the form accordingly.

Once updated, a pdf file of the form can be generated again, as per the instructions above, and uploaded to the new IRAS system. The same applies to any changes that might be necessary for the ARSAC PRA form.


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Combined Review applications for a Combined trial of an investigational medicinal product and an investigational medical device (IMP/Device trials)


Until the functionality for investigational medical devices is introduced into the new part of IRAS, all applications for IMP/Device trials will require applicants to complete information in both the standard and new parts of IRAS.


Pre-Application Devices Validation

IMP/Device trials will require Pre-Application validation from Medicines and Healthcare products Regulatory Agency Devices Division (MHRA Devices) prior to completing your combined review application in IRAS. If you believe your IMP/Device trial project requires submission to MHRA Devices you should ensure that you contact them first to discuss Pre-Application Validation in good time. You can contact them at: devices.regulatory@mhra.gov.uk. In your email please use the subject line; “CI/CT pilot – Devices Pre-Application Validation”.


Making Combined Review Application for an IMP/Device trial

The instructions below show the steps that are required for making an IMP/Device trial application via the combined review service. These steps are divided into the following sections -
  1. Completing the Medicines and Healthcare products Regulatory Agency (MHRA) Devices form in standard IRAS, and ensure you have all the associated documents ready as per the checklist

  2. Send your documents via an email link to MHRA Devices for Pre-Application Devices Validation

  3. After liaising with MHRA Devices, upload the MHRA Devices form and supporting documents to your combined review application in the new part of IRAS.

  4. Responding to Requests for Further Information


  1. Completing the Medicines and Healthcare products Regulatory Agency (MHRA) Devices form in standard IRAS, and ensure you have all the associated documents ready as per the checklist


    As part of your application you will need to include the ‘MHRA Devices form’ as a supporting document. This can only currently be completed and generated in standard IRAS.

    • Create a new project in standard IRAS and complete the project filter questions.

    • For project filter question 2 - select the ‘Ionising Radiation and Devices form for combined review of combined trial of an investigational medicinal product and an investigational medical device’. (please select this option even if your project does not involve ionising radiation)

    • For project filter question 4 - select the Medicines and Healthcare products Regulatory Agency (MHRA) Devices Division form.

    • Complete the MHRA Devices form (If your project also involves the use of ionising radiation, please see the section below). Ensure section F2 of devices form is ticked confirming MHRA may discuss the application with the research ethics service and relevant REC. Once completed, you should go to the forms submission tab and follow the instructions. Selecting the ‘proceed to submission’ button will not submit the form electronically. Instead, it will generate a pdf file of the MHRA Devices form.

      The MHRA Devices form will also contain a checklist tab, which will provide a useful list of supporting documents. Documents marked as mandatory must be submitted in all cases for the application to be valid. All documents and this checklist should be sent to MHRA for Pre-Application Validation..


    Please note: The IRAS ID generated in standard IRAS is only for the purposes of generating this form. You should only use the IRAS ID generated in your combined review application in the new part of IRAS (this will appear as a P-number reference). The new IRAS ID should be provided in the cover letter of the devices application.


  2. Send your documents via an email link to MHRA Devices for Pre-Application Devices Validation

    Once you have generated your MHRA Devices form in standard IRAS this form, along with all the required supporting documents, should be sent via a link to MHRA Devices for pre-application validation. To request the link to upload the documents please email: devices.regulatory@mhra.gov.uk, quoting the following in the subject line of your email “CI/CT pilot – Devices Pre-Application Validation”.

    MHRA Devices will then check your submission is valid. You will be contacted by them directly via email. Please note this is a validation process to check all the necessary documentation required for the CI submission is available, it is not a formal review.

    At the end of their validation check the MHRA will provide you with a list of documents they have checked as part of the pre-application validation. These are the documents that will be expected to be submitted as part of your combined review application. You must not make any changes to these documents after MHRA Devices have confirmed validation. Any changes at this point will likely invalidate your entire submission.


  3. After liaising with MHRA Devices, upload the MHRA Devices form and supporting documents to your combined review application in the new part of IRAS.

    Once confirmation that your application is valid has been received from MHRA Devices, you will be instructed to finalise your combined review submission in the new part of IRAS. This part of the application process is completed in the normal way and can be prepared in parallel whilst seeking validation from MHRA Devices. Please see our step-by-step guide for further information on how to prepare your combined review application.

    Once you are ready to upload your supporting documents, the MHRA Devices form and all documents that require submission to MHRA Devices (these will be listed in your pre-application validation confirmation email) should be uploaded and categorised as the document type; ‘Miscellaneous: MHRA only’.

    IMPORTANT: Some documents will need to be sent to both MHRA Devices and the REC (such as the patient information sheet (PIS)) where this is the case, these documents will need to be uploaded onto the system twice. You must ensure all duplicated documents are identical.

    For Example, when uploading the PIS. The PIS should be uploaded and categorised as usual for your combined review application. The same PIS is then uploaded again, this time to be sent to MHRA Devices with the document type; ‘Miscellaneous: MHRA only’. This will ensure the documents are reviewed by the appropriate bodies.


  4. Responding to Requests for Further Information

    Once your application has been submitted for review, any RFIs from MHRA Medicines and the REC will be issued in the new part of IRAS, in the usual way (please see the step-by-step guide for more details) while RFIs from MHRA Devices will be emailed directly to you. You will need to withhold responding to the MHRA Medicines/REC RFIs until all email RFIs have been resolved with MHRA Devices, and they have instructed you to submit the response to the RFI from Medicines and REC.

    RFIs from MHRA Devices will be managed outside of the IRAS system via email. You will be contacted directly with letters requesting clarifications or further information as necessary. Once all RFIs from MHRA Devices have been addressed you will receive a confirmation email and will be instructed that you can now provide all of your responses in IRAS. A final decision on the application (MHRA medicines, MHRA devices and REC) will be issued within 10 days of your RFI submission in IRAS.

    If you are required to make changes to your MHRA Devices form you can log into the standard part of IRAS, select the project and amend the information in the form accordingly. Authorisations will need to be re-signed.

    Once updated, a pdf file of the form can be generated again, as per the instructions above

    Please ensure any changes to your supporting documents as a result of the MHRA Devices review are updated in the new part of IRAS as part of your combined review submission. Updated versions should be clearly identifiable though your document management nomenclature. You will need to remember to ensure that any updated versions of duplicated documents (required for both REC and MHRA Devices submissions) match.


IMP/Device trials that also involve the use of ionising radiation

If an IMP/Device trial also involves the use of ionising radiation both processes outlined above should be followed in conjunction. i.e. the ‘Ionising Radiation and Devices form for combined review of combined trial of an investigational medicinal product and an investigational medicinal device’ should be selected in the project filter for question 2. The ‘Ionising radiation for combined review form’ the ‘MHRA Devices Form’ and the ARSAC form (if required), should be selected for project filter question 4.

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Page last updated: 14 December 2021




 
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