Medicines and Healthcare products Regulatory Agency (MHRA) Regulations: Primary legislation governing the conduct of clinical trials in the UK, including requirements for trial authorization, monitoring, and safety reporting
The Medicines for Human Use (Clinical Trials) Regulations 2004: UK regulations implementing the EU Clinical Trials Directive, covering all aspects of clinical trial conduct, from authorization to reporting
The Human Medicines Regulations 2012: Comprehensive legislation governing the authorization, manufacture, distribution, sale, and supply of medicines in the UK
UK Clinical Trials Regulations (post-Brexit): Updated regulations governing clinical trials in the UK following Brexit, including specific requirements for trial conduct and reporting
Data Protection Act 2018 (UK GDPR): Legislation governing the processing and protection of personal data, including specific provisions for health and research data
Human Rights Act 1998: Fundamental rights legislation that must be considered in the context of clinical research and patient participation
Health Research Authority (HRA) Requirements: Regulatory framework for health research in the UK, including approval processes and standards for research conduct
Research Ethics Committee (REC) Requirements: Mandatory ethical approval requirements and ongoing oversight for clinical trials involving human subjects
Good Clinical Practice (GCP) Guidelines: International quality standard for clinical trials that provides detailed guidance on trial conduct and participant protection
Declaration of Helsinki Principles: Fundamental ethical principles for medical research involving human subjects that must be incorporated into trial agreements
ICH-GCP Guidelines: International standards for designing, conducting, recording, and reporting clinical trials involving human subjects
MHRA Safety Reporting Requirements: Specific requirements for reporting adverse events, reactions, and safety concerns during clinical trials
SUSAR Reporting Requirements: Mandatory requirements for reporting Suspected Unexpected Serious Adverse Reactions in clinical trials
Clinical Trials Data Protection Requirements: Specific data protection measures required for handling clinical trial data and participant information
Common Law Principles of Contract: Fundamental legal principles governing contract formation, execution, and enforcement under English law
Contracts (Rights of Third Parties) Act 1999: Legislation governing the rights of third parties to enforce terms of a contract, relevant for multi-party trial agreements
Unfair Contract Terms Act 1977: Legislation controlling the use of unfair terms in contracts, particularly regarding limitation of liability
Clinical Trials Insurance Requirements: Mandatory insurance coverage requirements for clinical trials, including participant protection and liability coverage
NHS Research Governance Framework: Framework setting standards for research in the NHS, including responsibilities and accountabilities
Intellectual Property Rights Legislation: Laws governing the ownership and protection of intellectual property generated during clinical trials
Freedom of Information Act 2000: Legislation governing public access to information held by public authorities, relevant for publicly funded trials
Health and Safety Legislation: Laws ensuring the safety of trial participants, staff, and others involved in clinical trial conduct
