The Medicines and Healthcare Products Regulatory Agency (MHRA) has released updated guidance on "Good Clinical Practice (GCP) for Clinical Trials" conducted in the UK. This guidance outlines the ethical, scientific, and regulatory requirements that organizations must follow when conducting clinical trials involving human participants.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human participants. GCP ensures:
✔ Rights, safety, and well-being of trial participants are protected.
✔ Clinical trial data is credible and accurate.
✔ Compliance with regulatory requirements.
GCP is an internationally recognized set of ethical and scientific quality requirements that ensure the integrity of clinical trials and protect participants' rights, safety, and well-being. Compliance with GCP is mandatory for organizations involved in clinical trials, including pharmaceutical companies, contract research organizations, universities, NHS hospitals, charities, GP practices, and laboratories analyzing clinical trial samples.
Organizations must promptly notify the MHRA of any serious breaches of GCP or the trial protocol. A serious breach is defined as a deviation that significantly affects the safety, physical or mental integrity, or scientific value of trial participants.
The MHRA conducts inspections of clinical trial sites based on a risk assessment to ensure compliance with GCP standards. These inspections may occur when serious breaches are reported or during the marketing authorization application process. The risk-based approach allows the MHRA to focus resources on areas with the highest potential impact on participant safety and data integrity.
Before an inspection, organizations are required to provide specific documentation to the MHRA. This typically includes the trial protocol, investigator brochures, standard operating procedures, and records of previous audits. Providing accurate and comprehensive documentation facilitates a smooth inspection process.
During an inspection, the MHRA assesses compliance with GCP by reviewing documentation, interviewing staff, and observing trial processes. The inspection focuses on informed consent procedures, data management, investigational medicinal product handling, and adverse event reporting.
Post-inspection, the MHRA provides a report detailing any findings and required corrective actions. Organizations must address these findings within specified timelines to ensure ongoing compliance with GCP standards. Failure to implement corrective actions can result in regulatory actions, including suspension of trial activities.
The MHRA publishes metrics on GCP inspections to provide transparency and promote continuous improvement in clinical trial conduct. These metrics include the number of inspections conducted, common findings, and trends over time.
In cases of significant non-compliance, the MHRA may issue infringement notices or letters. These formal communications outline the nature of the non-compliance and the required actions to rectify the issues. Timely and effective responses to infringement notices are essential to maintaining the integrity of clinical trials and protecting participant safety.
The MHRA encourages a risk-adapted approach to clinical trials, tailoring the design and conduct of trials based on the level of risk associated with the investigational medicinal product and the trial population. Effective oversight and monitoring are critical components of GCP compliance. Sponsors are responsible for implementing monitoring plans that ensure the quality and integrity of trial data and the protection of participants.
The MHRA hosts a GCP discussion forum to facilitate communication and knowledge sharing among stakeholders involved in clinical trials. The forum addresses topics such as legislation, monitoring, data management, and quality systems, providing a platform for addressing common challenges and sharing best practices. The MHRA guides the access of sponsor representatives to electronic health records (EHRs) during clinical trials.
The MHRA organizes GCP Stakeholder Engagement Meetings (StEM) to engage with stakeholders, discuss regulatory updates, and address concerns related to GCP compliance. Recognizing the critical role of laboratories in clinical trials, the MHRA conducts GCP Laboratories Stakeholder Engagement Meetings. These meetings address specific challenges faced by laboratories, discuss regulatory requirements, and promote the implementation of Good Clinical Laboratory Practice (GCLP) standards.
For full details, visit: Good Clinical Practice for Clinical Trials (MHRA)
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