Federally Regulated Clinical Trials
Patient safety is at the forefront of concern with clinical research around the world today. Patient safety is important during the conduct of clinical trials as well as after the trial is over where study results are used to make decisions about health care choices for patients. The CRCU has extensive experience in designing, developing, and conducting clinical trials that are subject to federal regulations.
When a project is first evaluated during the grant proposal stage, determination of regulatory requirements for the study is essential. The data quality of the proposed project must comply with the standards of the FDA Bioresearch Monitoring Program, which covers all FDA product areas (i.e., drugs, biologics, medical devices, radiological products, foods, and veterinary drugs). Activities must be conducted in accordance with the FDA Bioresearch Monitoring Program unless the project does not require the compliance level specified by this program. The need for FDA compliance is contingent on the scientific goals and content of the study. The CRCU works with the scientific team to identify the necessity for FDA Bioresearch Monitoring Program compliance and then develops the project based on this determination.
When FDA compliance is required, the CRCU will develop the study using Oracle Clinical and Oracle RDC software. These industry leader clinical data management products are 21 CFR Part 11 compliant and have been fully validated within the CRCU environment. The CRCU is unique within the University for our capability to conduct clinical trials at this level of compliance.
