Clinical Trial Disclosure and Data Transparency Conference
Featured Oral Abstract: Using Systems Integration and a Central Approach to Achieve Compliance with ClinicalTrials.gov
Issis J Kelly Pumarol, MD
- Research Subject Advocate
- Wake Forest Baptist Health, United States
Changes, including new results reporting rules and NIH policy on clinical trials registration, present compliance challenges for investigators and institutions. We performed a compliance review revealing the need for institutional awareness of these requirements, how to navigate the ClinicalTrials.gov system, and hands-on support for study teams in managing the records. This central approach of monitoring, education, and support could be replicated at any institution. By providing investigators with resources to comply with regulations and ethical obligations, we hope to facilitate research.