The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical Practice (GCP) for Clinical Trials", that updated information on the GCP inspection dossier clinical trial spreadsheet.
The guidance explains how to demonstrate compliance with GCP standards to the MHRA and what to expect during an inspection.
MHRA defines GCP as a set of internationally-recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting clinical trials that involve people.
In order to ensure compliance with GCP, the 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
GCP inspections are most commonly carried out under the risk-based compliance programme, which can either be a systems-based process or a trial-based process. A GCP systems inspection examines your organization's system for conducting clinical trial research, and a trial-specific GCP inspection examines completed trials.
If you are looking to gain in-depth knowledge of the GCP for Clinical trials that MHRA applies, click this LINK.
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