On 22nd July 2024 the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued comprehensive guidance on "Good Clinical Practice (GCP) for Clinical Trials". This guidance aims to ensure the safety, rights, and well-being of trial participants while maintaining the integrity and quality of trial data. The guidance explains how to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Good Clinical Practice (GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.
Clinical Trial of Investigational Medicinal Product (CTIMP) is a clinical study designed to investigate the safety or efficacy of a medicinal product in humans.
The GCP guidance outlines the ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human subjects. Compliance with these standards provides public assurance that the rights, safety, and well-being of trial participants are protected, and that clinical trial data are credible.
This guidance applies to all clinical trials of investigational medicinal products (CTIMPs) conducted in the UK. Organisations that may have to comply with GCP include:
pharmaceutical companies
contract research organisations
universities
NHS hospitals
charities
GP practices
laboratories analysing samples originating from a clinical trial (including NHS, academic and commercial laboratories)
To ensure compliance with GCP MHRA:
asks trial sites to notify them of serious breaches
carries out inspections of trial sites where serious breaches are reported
carries out inspections of trial sites that sponsor clinical trials, mostly based on a risk assessment
carries out inspections of sites when companies apply for marketing authorisations
The guidance key covers topics including reporting serious breaches, risk-based compliance inspections, pre-inspection and post-inspection actions, GCP inspection metrics, infringement notices and letters, risk-adapted approaches to clinical trials, oversight of investigational medical product trials, on-site access to electronic health records by sponsor representatives, and GCP stakeholder engagement.
For more detailed information, refer to the full guidance document.
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