The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents.
It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
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MHRA recommends to perform and document a risk assessment for each proposed clinical investigation as early as possible to determine whether it falls under the Clinical Trials legislation and whether there are barriers to its execution.
The guidance states: “The risk assessment must be specific to the proposed trial and whilst the process may include templates or a guide on the areas to consider in the risk assessment, care should be taken to examine the potential risks of the proposed trial, which may present new areas that have not been considered in previous trials. This is why it is a bespoke approach.”
Moreover, Sponsors should keep the risk assessment in the trial master file and, where appropriate, inform site staff of its content. It has to be re-examined when new information becomes available, such as after an interim analysis.
The second MHRA guidance lists aspects that are important in determining the oversight and monitoring strategy, explaining that sponsors should establish processes that reflect the known risks of a trial. If an error in an activity would have a negative impact on participant safety and trial results, sponsors should make it a focus of oversight and monitoring.
The MHRA guidance moves away from the traditional approach of seeking to assess compliance with every detail of the protocol and checking every data point against source documents.
Read more on the MHRA website.
See the MHRA Guidance.
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