MHRA Identifies Common Flaw In Managing Protocol Deviations
By Paul MacDonald
Understanding protocol deviations is critical to preserving the scientific integrity of your study – so why are many companies doing it wrong?
In one audit of protocol deviations, 304 of the 447 deviations reported to an ethics committee were related to study procedures such as missing visit windows, missing assessments, and incomplete case report forms.1 If this audit is representative, then the majority of reported deviations are subject-related protocol deviations that will surface within the EDC. Given the scale and importance of deviations in a trial, we need to stop and take notice of the MHRA’s recent comment that many companies are managing them incorrectly.
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