Time: 11:00am to 12:15pm
Content level: Intermediate
It is scientifically and ethically imperative for researchers to understand it is a key commitment to report the results of clinical trials to research participants, so the advanced knowledge can be utilized collectively to make informed medical decisions. This session will discuss the most recent federal mandates, pertinent requirements of clinical trials disclosure and good practice. The presenters will share the approach that Rutgers, The State University of New Jersey, took to establish a robust, effective program for clinical trials registration and results reporting. Rutgers’ Human Subjects Protection Program (HSPP) has adopted a proactive plan to identify key issues and facilitate investigator to stay compliant within ClinicalTrials.gov records through the HSPP’s guidance, including a website and ongoing, customized trainings.
- Describe why clinical trials disclosure matters and List resources and tools to assist investigators and organizations in maintaining compliance for clinical trials disclosure.
- Identify key elements to establish a system in your organization to facilitate and monitor clinical trials registration and results reporting.
Cheryl Forst, RN, BSN, CCRP, Director, Human Subjects Protection Senior Analysts Rutgers, The State University of New Jersey; Rebecca Niem-Tzu Chen, MS, MEd, CCRP, Human Subjects Protection Senior Analyst, Rutgers, The State University of New Jersey