An investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie, it assesses a medicine’s efficacy and safety.

This Practice Note provides an introduction to the process of testing medicinal products in humans (known as clinical trials). It sets out the UK regulatory framework for clinical trials, explaining the changes introduced into UK regulation by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (UK CTR 2025), SI 2025/538. It further explores some practical considerations including how to apply for authorisation to conduct a clinical trial, how to conduct and conclude a clinical trial, how to prepare a clinical trial protocol and links to various clinical trial agreements (CTAs). It also discusses the various stages of clinical trials (referred to as phases I, II, III and IV), the parties involved, informed consent and the special rules relating to minors and incapacitated adults. Finally, it briefly considers clinical trials conducted outside the UK as well as related areas of law, including data protection for clinical trial data and personal data, clinical trial disclosure, and the research and Bolar exemptions in patent law. The UK and EU have different regulatory frameworks for clinical

Financial Services analysis: What do the European Commission’s plans to clamp down on the ‘shadow banking’ industry entail? Brian McDonnell, partner at Addleshaw Goddard, discusses the proposed changes.

Law360, London: Close Brothers Ltd and other motor finance lenders must fully disclose commissions charged to customers taking out a car loan, or face repaying the secret fee, a London appeal court ruled on 25 October 2024 in a landmark test case.

Law360, London: London merchant bank, Close Brothers, said on 12 February 2025 that it plans to set aside £165m to cover potential costs stemming from a Financial Conduct Authority (FCA) probe into motor finance commission agreements and a related appeal at the UK's top court.

Subject to some exceptions, a close company is a company (1) which is controlled by five or fewer participators, or (2) which is controlled by its directors, or (3) more than half of the assets of which would be distributed to five or fewer participators, or to participators who are directors, in the event of its winding up.

to be applied to determine whether an employer should be held vicariously liable for an employee’s unauthorised, intentional wrong.

This Practice Note considers the closed material procedure (CMP) in CPR 82 which allows the state to disclose national security-sensitive material to a judge without having to disclose the material to opposing parties. This Practice Note also addresses how to make an application to withhold national security sensitive material under CPR 82.13. The closed material procedure (CMP)—evolution and rationale The state has historically been able to safeguard matters of national security, protecting information and documents relating to them on the basis of an assertion of public interest immunity (PII)—see Practice Note: Public interest immunity. If the PII application was successful, the advantage for the state was that the protection of national security-sensitive information was achieved as the documents would not be disclosed to anyone and would not feature in, or have any bearing on, the matters being litigated. But nor could the state itself make use of them because of the exclusion under the PII certificate. If however the PII application failed, then the documents were disclosable to all parties in the litigation. The state then had the

A service for persons with hearing disabilities that translates television program dialog into written words on the television screen. Closed captioning is not visible without the use of a specially installed decoder.

An AIF other than an open ended AIF.This definition is of importance, primarily because different liquidity management and valuation rules apply to AIFMs depending on the types of AIFs they manage. AIFMs managing closed ended AIFs are (amongst other things) subject to more permissive minimum capital requirements and less frequent valuation requirements.

Listed closed ended investment funds are regulated as AIFs under the AIFMD, as implemented, but also subject to (amongst other things) the UK Prospectus Regulation, Retained Regulation (EU) 2017/1129, the UK Market Abuse Regulation, Retained Regulation (EU) 596/2014 and the Listing Rules as specified in the FCA Handbook, Listing Rules chapter 15.

In the context of the market abuse regime, the period of 30 calendar days before the announcement of an interim financial report or a year-end report which an issuer is obliged to make public according to the rules of the trading venue where the issuer's shares are admitted to trading or national law. A person discharging managerial responsibilities (or PDMR) within an issuer must not conduct any transactions on its own account or for the account of a third party, directly or indirectly, relating to the shares or debt instruments of the issuer during a closed period (article 19(1) of the UK Market Abuse Regulation).