Project Scope - Access to study data with the ability to aggregate various sources of data enabling oversight of the clinical data and operational data in near real time. This includes frequency of data transfers, audit trail, and facilitating PI oversight of medical care of patients.
- Ideal technology requirements (very broad – patients, sites, CRO-Sponsor connection) and new vendor qualification expectations.
- Data review plan (medical review, statistics, data cleaning activities, operational, etc.), with clear defined purpose of what each role is reviewing, what, when and why.
- Definition of robust “monitoring” strategy as required by ICH.
- Connection to on-site monitoring, using centralised monitoring to determine on-site monitoring needs,
site trends allowing for early, targeted site feedback for CRA to have more focused site engagement. - Discuss different data oversight strategies and methodologies and when to consider use of
visualisations related to types of data reviewed ( visualisations focused on critical data only, visualisation that could contribute to a significant deviation vs. all deviations). - Facilitate risk mitigation through the trial, ensuring risk linkage to Central Monitoring oversight.
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