Regulatory Issues in Clinical Research and Clinical Trials

Catalog description

(same as BIOL_EN 8004 ). The goal of the course is to highlight key FDA regulatory issues for conducting human clinical trials and clinical research. For clinical trials, FDA has set up several compliance programs and guidance documents as a part of human subject protection (HSP)/ Bioresearch Monitoring (BIMO) initiatives. The aim of the program was to strengthen FDA oversight and protection of subjects in clinical trials and to preserve confidentiality of data. The HSP/BIMO initiative comprehends all FDA regulated clinical trials including human drugs and biological drug products, devices, foods, and veterinary medicine. The course is designed for students in medical professions, management, biomedical engineering, and related areas. Adequate knowledge regarding FDA guidance in conducting human clinical trials and clinical research will help professionals steer drug/device development and commercialization in their respective field. This course will be offered online only. An introduction to essential disciplines for conducting clinical trials and clinical research will be provided. The basics of good clinical practices (GCPs), biostatistics and clinical epidemiology in relation to clinical trials will be presented. Several relevant case studies for conducting clinical trials, both nationally and internationally, will be discussed. The importance of data collection and data management while conducting clinical trials will be explained. Graded on A-F basis only. Credit Hour s : 3 Recommended: Knowledge in biomedical sciences, clinical sciences