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Description
Clinicaltrials.gov became publicly available in 2005 and was created as a resource for patients, physicians, regulatory bodies, and funders to provide the most up-to-date information about clinical trials conducted throughout the nation. Although motivated to comply with regulations, those tasked with maintaining records, found the website to be cumbersome and this has resulted in thousands of poorly maintained records. The Food and Drug Administration (FDA), has begun informing institutions and researchers of the potential incurred monetary penalties upwards of $13,000 per day per record for failure to submit their clinical trial results. As a High Reliability Organization, Henry Ford Health (HFH) has a commitment to research participants to provide safe and high-quality trials and provide scientific validity and transparency while meeting ethical standards. The desire and responsibility to meet the compliance mandate became a high priority for HFH leadership who sought support from the recently formed centralized Clinical Trials Office to lead the effort of identifying non-compliance, mitigating outstanding records, and tasked to develop a process to ensure compliance is established and maintained.
Publication Date
3-12-2024
Publisher
Henry Ford Health
City
Detroit, Michigan
Keywords
Quality Expo, posters, poster competition
Recommended Citation
McEachren, Kayliegh; Marl, Stephanie; Pearce, Tiffany; and Carrillo, Sonia, "Project #38: ClinicalTrials.gov: building compliance within HFH" (2024). Quality Expo 2024. 41.
https://scholarlycommons.henryford.com/qualityexpo2024/41
