Technical Assurance submission guidelines for combined review applicants

Pharmacy Assurance

The submissions guidance for applications to Pharmacy Assurance is available on the standard part of IRAS.

Radiation Assurance

Document requirements for combined review submissions

The HRA expects that the following documents are submitted in all instances. For studies involving the administration of radioactive substances there are additional document requirements which are set out in the next section of this guidance:

• research exposure form; this is available on the standard part of the IRAS website under the sub-section 'submission process'. It should be completed as usual, though on page one please specify both the IRAS ID in the new part of IRAS and the IRAS ID in the standard part of IRAS (this relates to the completion of Part B Section 3);
• protocol;
• any participant information sheets and participant consent forms where there are references to ionising radiation exposures. If there are additional information sheets and consent forms for the study where there is no expectation that there are any references to ionising radiation exposures, there is no need to submit these for review, but please make it clear in your covering email which documents these are;
• imaging manual, if applicable and available at the point of submission;
• radiotherapy manual, if applicable and available at the point of submission;
• PDF screenshots of the new IRAS form with the following questions completed:

·      Study information B2 Clinical interventions. Please specify the maximum possible number of procedures in columns two, three and four

·       Study information B4 What are the potential risks and burdens for research projects and how will you minimise them?

·       Study information F1 Does the study involve exposure to radioactive materials?

·       Study information F2 Does the study involve other diagnostic or therapeutic ionising radiation?

Please note that only information regarding radiation exposures needs to be completed in the new part of IRAS in order to submit to Radiation Assurance. Information unrelated to radiation exposures is not needed for Radiation Assurance and can be added by you in the background whilst the process is ongoing. We need this information to ensure that the information which is reviewed by the REC is consistent with the study documents.

Study documents do not need to be final versions but references to and details regarding the radiation exposures should be finalised so that no changes or amendments are required.

If you are submitting through the HRA-managed route and wish to request either particular HRA-registered reviewers or trusts/health boards to complete the review, please also submit the HRA-managed Reviewing Trust/Health Board Request Form detailing up to three HRA-registered reviewers or trusts/health boards.

If you are submitting through the self-managed route, please submit the self-managed Study Registration Form.

Both of the above forms are available on the standard part of the IRAS website under the sub-section 'submission process'.

In your submission covering email to Radiation Assurance, please also provide the following information:

• confirmation that you intend to submit your study through combined review
• if known, the latest date on which you intend to submit through combined review (this will be the last day of the submission period for the REC meeting which you intend to submit to)
• name of the sponsor organisation, and whether they are commercial or non-commercial
• which UK nation the lead NHS/HSC R&D office is in and, if known at the point of submission, the name of the lead NHS/HSC R&D office
• whether the study involves adults lacking capacity.

Additional document requirements for studies involving radioactive substances

If your study involves the administration of radioactive substances, you will also need to submit to ARSAC for PRA approval. This is only possible by using the standard part of IRAS. In this instance please also submit a draft PDF copy of either the standard IRAS form (if your application was created before 14 December) or the Ionising Radiation for combined review Form (if your application was created from 14 December) with the following questions completed:

• project filter page question 2 (in particular the questions about ionising radiation exposure)
• question A13
• question A19

We need the draft PDF to ensure that the information that is sent to ARSAC is consistent wiht the information in the rest of the application.

You do not need to do anything in Part B Section 3 as the reviewers will provide the information for you to include. We only need the information pertaining to the radiation exposures to be provided in the PDF, so you can work on providing the other information in the background as needed for the ARSAC PRA submission.

Consistency review

The HRA will still conduct a consistency review, although the required documents for combined review studies to pass this stage are slightly different.

Please continue to refer to the Consistency Review Criteria available under 'tips for a successful application' on the Radiation Assurance submissions page on IRAS, but be aware that instead of point b (referring to which sections of the standard part of IRAS should be completed) we will expect that the documents contained in this guidance have been submitted with the relevant sections completed.

We recommend that you take into consideration the other points in the 'tips for a successful application' section as these are still relevant for combined review applicants.