UK

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 ...

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...

2.1 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 ...

3.1 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...

4.1 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...

5.1 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...

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...

7.1  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...

8.1 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...

9.1 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...

10.1 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 ...

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...

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