04/27/2014

This is the specific description of the project that was part of the discussion at ACRP yesterday at the global conference in San Antonio and also will be pulblished in the Clinical Researcher (formally The Monitor) in August 2014.

Quality Risk Assessment - Why Should Sponsors Have All the Fun?

Recent US and EU best practice initiatives promote an alternative approach for sponsors’ oversight of clinical trials that includes quality risk management, but most investigative sites have not yet embraced these concepts. Not just Sponsors, sites also need clinical quality systems in place that include risk-based monitoring approaches that incorporate a proactive assessment and action plan for project risk mitigation. The purpose of this article is to present survey data from industry stakeholders collected during three ACRP local chapters’ meetings (in California and North Carolina) regarding trends and attitudes about the use of study risk-based oversight approaches, and promote incorporation of risk assessment tools by sites in study management processes. A risk assessment tool adapted to site GCP practices was presented at each meeting and is included. Attitudes were measured before and after the risk assessment presentation as well as again months after the presentation. Data results support the willingness and perceived benefit of site adoption of quality risk management practices to better ensure compliance, human subject protection, meeting project timelines and enrollment.