CCSA is proud to announce we have been selected by the FDA, Center for Tobacco Products (CTP), Office of Compliance and Enforcement (OCE), Quality Assurance/Quality Improvement Program, to provide on-site data quality monitoring and other QA/QI activities. CTP has established an agency wide Research Quality Assurance Program for FDA-sponsored intramural and extramural human subject research (HSR) to ensure the quality and integrity of data and information of HSR studies and to ensure the rights and welfare of subjects involved in HSR sponsored or conducted by FDA researchers. CCSA’s aim in assisting CTP is to improve the data collection process and facilitate and conduct QA/QI site monitoring visits in support of the CTP. Some of the tasks that CCSA is involved in include annual development of the QA/QI site monitoring visit schedule, pre-site-monitoring visit reviews and scheduling, conduct of site monitoring visits, timely development and submission of the site visit review reports, follow-up activities, closeout activities, and project management.
