For a study to be considered for portfolio adoption it must:

• • Meet the definition of research (as outlined in the Department of Health and Social Care eligibility criteria) as follows:

Research can be defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes: audit; needs assessments; quality improvement and other local service evaluations. It also excludes routine banking of biological samples or data except where this activity is integral to a self-contained research project designed to test a clear hypothesis.

• • Have appropriate ethical approval; and HRA Approval where required.

  • Have full research funding (i.e. funding to meet all Research Costs in compliance with the AcoRD guidance).

The source of research funding is the principal determinant of eligibility for NIHR portfolio adoption:

• • Studies that are funded by the NIHR and / or other areas of central Government and those which are funded by NIHR non-commercial partners, are automatically eligible for consideration for NIHR CRN support provided they meet the definition of research above. Please find more information on the Eligibility for NIHR Clinical Research Network support web page.

If you think your study is eligible for portfolio adoption, please follow the instructions on how to apply for NIHR CRN support. Early engagement with NIHR CRN support helps with optimising study delivery upfront. If it is not automatically eligible, the CRN Eligibility Team and speciality subject specific experts will carry out the assessment and decide whether the study is eligible for portfolio adoption.

If your study is an English-led CTIMP and you are applying for HRA Approval through the HRA and MHRA’s combined review service, you must apply for CRN support through the new Non-commercial Portfolio Application service in CPMS.

The new Non-commercial Portfolio Application service: The following study types can now apply for CRN support via the new service, which allows investigators to apply earlier and receive an eligibility decision sooner to benefit from the full range of support that our study support service offers:

• English-led CTIMP (clinical trials of investigational medicinal products) studies which are led in England and going through the Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency’s (MHRA) Combined Review Service, and;

• English-led studies that do not need, and therefore are not applying for, HRA Approval in the Integrated Research Application System (IRAS).

Studies that require HRA Approval but are not being progressed through combined review: These studies should continue to apply for NIHR CRN support by selecting ‘yes’ to question 5b of the IRAS Project Filter. This will ensure key information from your IRAS submission is automatically shared with us. This information, including the IRAS form, the study protocol and grant award letter(s), will be used to determine eligibility. You will be notified of the outcome, via email.

If you are unable to apply via either of these routes, contact your Local CRN for advice on how to proceed.

If you require any local advice on applying for portfolio adoption or on eligibility criteria please contact crneoe.studysupportservice@nihr.ac.uk

Once your study has been granted the portfolio eligibility status, you can contact the NIHR study delivery officer for local access to CRN-funded possibilities to aid recruitment.

Further information

• Further information on eligibility for NIHR support can be found in eligibility FAQs.

• You can read about the benefits of portfolio adoption here.