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UK
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0. Record of Amendments
DCT Feasibility Assessment UK The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...
1. Executive Summary
This guidebook provides an overview of the current and proposed regulatory landscape applicable in the United Kingdom in relation to Decentralized Clinical Trials (“DCTs”) with medicinal investigational products. Following the United Kingdom’s dep...
2. General Questions
2.1 Name of Regulatory Authority The UK regulatory authority responsible for clinical trial approvals, oversight, and inspections in the United Kingdom (UK) is the Medicines and Healthcare Products Agency (MHRA) . The MHRA grants permission ...
3. Ethics Committee (EC)/ Institutional Review Board (IRB)
3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant. Submissions of clinical trial applications (CTAs) in the UK are made to the Integrated Research...
4. Regulatory Authority (RA)/ Competent Authority (CA)
4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. Regulatory Authority Requirements As specified in the MHRA's “Clinical trials for med...
5. Investigator and Investigational Product
5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)? The Sponsor is usually expected to be the employer of the chief investigator (CI) in the case of non-commercial research, or the funder i...
6. Biological Specimen
The term “specimen” is not referenced within the UK. Instead, the following terms are used in relation to specimens: “Relevant material” or “human tissue” is any material from a human body, other than gametes, that consists of, or includes cel...
7. Decentralized Clinical Trials
7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . 7.2 Is there any specific regulation/guidance on the use of DCT elemen...
8. Data Management
8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest? Applicable data privacy legislation in the UK is as follows: UK GDPR Data Protection Act (2018) Health Servic...
9. Subject Considerations
9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? This area of regulation is evolving. The outcome of the MHRA, HRA, a...
10. Roadmap of the Submission Process of a Clinical Trial
10.1 Clinical Trial with Investigational Medicinal Product Combined Review is the way to seek approvals for new Clinical Trials of Investigational Medicinal Products and combined medicine and device trials. A single application using the IRAS ...
11. Regulatory Overview - DCT Components
12. Resources
Medicines and Healthcare Products Regulatory Agency (MHRA) https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency Health Research Authority (HRA) https://www.hra.nhs.uk/ Medicines and...
13. Forms
N/A