Regulatory Knowledge and Support Clause Samples

Regulatory Knowledge and Support. The Regulatory Knowledge and Support Component provides consultation, guidance, and investigator-focused regulatory tools, consultation, and training activities. It offers expertise and support in clinical research quality improvement activities. The team helps investigators learn how to prepare and maintain regulatory documents and interact with regulatory agencies. To advance study participant safety, research participant advocacy services and a data & safety monitoring resource are being developed. To date, we successfully established our consult service and developed the DSMP and research participant advocacy frameworks. We authored a CITI-based training module in cultural diversity and are in the process of developing additional training modules for clinical research coordinators and compliance topics. The Office of Regulatory Support and Quality Assurance provided seminars on regulatory issues. IRB Share is up and running at the University. Last, in collaboration with the Office of Regulatory Support and Quality Assurance, ¡Alianza!, and the Research Ethics and Research Training Components, we initiated a multi-CTSA effort to build a research coordinator career ladder, standardize job descriptions, and offer a concomitant training curriculum. This is a very high priority at our University voiced both by our Vice ▇▇▇▇▇▇▇ for Research and School of Medicine Executive ▇▇▇▇ for Research and has been very well received by members in the CTSA Consortium. Metrics include:  # and profile of users of and satisfaction with consult and study participant advocacy services (process)  # and profile of training attendees (process)  # of training courses/seminars offered and user satisfaction with them (process)  Successful operationalization of study participant advocacy services (outcome)  Successfully implemented services and training related to regulatory activities (outcome)  Successful educational programs to improve knowledge of regulatory requirements (outcome)  Implementation of a Universal Consent form for participation in C/T research In ¡Alianza! we are working to establish a network of centralized, affiliated locations for patient-oriented research. We are enhancing infrastructure to ensure highest ethical and regulatory standards and promote scholarly activity while accelerating the pace of research translation. We are also building a centralized core that will offer activities to enhance education, training, competency, career development, and ...