
WATCHING OVER YOU
OVERSIGHT MONITORING
CurAccel provides two approaches to oversight monitoring.
1. Risk-Based Approach (Initiated during the Study Start-Up Phase)
Per the US FDA guidance for industry in Aug 2013, - "Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.":
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Sponsors of clinical investigations should develop risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof.
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The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.
CurAccel assists our sponsor partners in developing and executing an Oversight Monitoring Plan (OMP) that meets and exceeds US FDA guidance.
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CurAccel’s Oversight Monitoring program aims to ensure the quality and integrity of clinical data, provide a consistent approach to study conduct among investigative sites, assure completion of the oversight projects on time to the highest quality standards, and provide practical guidelines.
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CurAccel's Oversight Monitoring Plan (OMP) describes the specifications and tasks performed by the Oversight Monitor during Oversight Monitoring Visits.
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This plan is a working document that should serve as a reference over the lifecycle of the project.
2. Rescue Approach
Rescue Oversight occurs when a trial faces significant challenges despite the execution at Start-Up of Risk-Based Oversight process. These challenges can be caused by:
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Lack of appropriate conduct of said Oversight process/plan by the sponsor or vendor contracted to perform Oversight activities for the clinical trial since the Start-Up Phase
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An inadequate initial Oversight Monitoring Plan (OMP) developed during Start-Up phase by the sponsor or CRO that did not appropriately address factors that could affect performance, organizational changes, and other safety performance indicators that make-up the risk profile.