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When a clinical trial authorisation (CTA) is needed

Use the online algorithm Is it a clinical trial of a medicinal product? (PDF, 68KB, 2 pages) to find out if your study needs MHRA authorisation.

The algorithm is a set of questions that determine:

• whether the substance youre testing counts as a medicinal product
• whether your trial counts as a clinical trial within the scope of the relevant legislation

You can also read the Mock examples to assist with the question Is it a clinical trial of an investigational medicinal product? to help you decide if your study needs a CTA.

For further advice you may also wish to consult your local regulatory department or research governance team.From October 2021 the SCOPE advice service will only be available via self-service using the guidance on this webpage.

Please note

This guidance relates to clinical trials of medicinal products. If your query relates to a clinical investigation of a medical device please contact info@mhra.gov.uk.

To get advice on whether a trial is a Type A, B or C based on risk assessment please view our guidance on risk-adapted approaches to the management of clinical trials of investigational medicinal products. Should you have a query regarding any proposed risk adaptations please send an email with your query to clintrialhelpline@mhra.gov.uk.

If your query relates to whether the study product(s) is/are an Investigational Medicinal Product (IMP) or non-IMP, please consult the document Guidance on investigational medicinal products (IMPs) and non investigational medicinal products (NIMPS) (Rev. 1, March 2011) .

If you wish to know whether your product could be a medicine, rather than a medical device or other product (such as a food supplement or cosmetic), please refer to the medicines borderline page.

Trial Sponsor and legal Representative

The sponsor of a clinical trial is the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial. Clinical trials can also be sponsored by two or more persons or organisations. This is referred to as joint or co-sponsorship. Regulation 3 (2) of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) provides further information on the responsibilities of the sponsor(s).

A sponsor of a clinical trial needs to be established in the UK or a country on an approved country list which would initially include EU/European Economic Area (EEA) countries. If this is not the case, then the sponsor must have a legal representative who is so established.

Registration of your clinical trial

From 1 January 2022 the Health Research Authority (HRA) will automatically register clinical trials with ISRCTN Registry as one of the steps to ensure research transparency. This will start with clinical trials of investigational medicinal products (CTIMPs) that are submitted through combined review in the new part of IRAS. It is still a standard condition of a Research Ethics Committee (REC) favourable opinion for clinical trials to be registered on a publicly accessible database, this requirement has not changed. For any submissions submitted up to 31 December 2021 (either via new IRAS or old IRAS) you should register your clinical trials on an established international register such as ISRCTN Registry or ClinicalTrials.gov. If you wish to defer registration of your trial (for example if it is an adult phase I trial) then contact the HRA at study.registration@hra.nhs.uk.

You should continue to include the registry number(s), if available, in section A.5. of the application form in the Integrated Research Application System (IRAS) when you prepare your application. If this is not available at the time of application, you should email this to the MHRA at clintrialhelpline@mhra.gov.uk with subject line Clinical Trial Registration within six weeks of recruiting the first research participant. You should also let the REC know your registration number as soon as possible.

Combined review of clinical trials of investigational medicinal products

From 1 January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) applications will be prepared, submitted and reviewed via the combined review service. This offers CTIMP applicants and sponsors a single application route and co-ordinated review by MHRA and the research ethics committee, leading to a single UK decision.

Applications for combined review are prepared and submitted in a new part of the Integrated Research Application System (IRAS). Further information on the process is available via the Health research Authority website.

In Vitro Diagnostic Medical Devices (IVDs)

Unless an exemption applies, all IVDs being placed on the market or put into service in the UK are required to have the relevant mark of conformity (UKCA, CE or CE UKNI).

This includes IVDs used in clinical trials of medicines (CTIMP) to stratify patients for inclusion/exclusion in the trial or stratified to a cohort within a trial.

At the time of the clinical trial application, where clinical performance of the IVD is yet to be demonstrated, for CTIMPs taking place in GB the IVDs must have a UK mark of conformity only for the analytical performance of the IVD (e.g. detection of a biomarker). This will include reagents, equipment, calibrators, controls and softw

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