If this is not the case, then the sponsor must have a legal representative who is so established.
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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).Ī 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. This is referred to as joint or co-sponsorship. Clinical trials can also be sponsored by two or more persons or organisations. 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. 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. Should you have a query regarding any proposed risk adaptations please send an email with your query to 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. If your query relates to a clinical investigation of a medical device please contact 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. This guidance relates to clinical trials of medicinal products. 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.įor further advice you may also wish to consult your local regulatory department or research governance team.įrom October 2021 the ‘SCOPE’ advice service will only be available via self-service using the guidance on this webpage.
The algorithm is a set of questions that determine: 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. When a clinical trial authorisation ( CTA) is needed We have published guidance on managing clinical trials during the COVID-19 outbreak, and on clinical trials applications for COVID-19. Clinical Trials and coronavirus (COVID-19)
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