Journal
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
Volume 55, Issue 4, Pages 733-742Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s43441-021-00269-w
Keywords
Protocol deviation (PD); Quality Management System (QMS); Risk management; Issue management; Risk assessment categorization tool (RACT); TransCelerate
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Improving interpretation of existing guidelines and managing protocol deviation processes can increase process efficiencies, reduce noise, and support rapid identification of important protocol deviations.
Improving interpretation of existing guidelines and management of protocol deviation processes could increase process efficiencies and help reduce noise to support rapid identification of important protocol deviations. Towards this end, TransCelerate identified key principles to build upon and clarify the definition of a protocol deviation and developed a holistic approach to protocol deviation management. The approaches are flexible to suit a variety of indications, study designs, and investigational agents while also supporting consistent application within a study, program or organization.
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