CLINICAL TRIAL MANAGEMENT

Clinical Trials Pre- and Post-Award Management

Clinical trials are research studies to determine whether new drugs or treatments are safe and effective. These research programs are conducted with patients to evaluate a new medical treatment, drug or device, and their purpose is to find new and improved methods of treating different diseases and special conditions. Private companies such as pharmaceutical companies sponsor such trials. The scope of work known as the "Protocol" may be solely formulated by the sponsoring company or it may be designed by the principal investigator. In either case, clinical trials are considered sponsored projects and must be reviewed and approved as such.

The review of clinical trial differs from other research projects because their proposals are different. The below sections provide definitions related to clinical trials, and  information about the review process of clinical trials, the pre- and post award procedures for managing clinical trials, as well as define the responsibilities of principal investigators and OGC.

1. Definitions

2. Types and Phases of Clinical Trials

3. Pre-Award Procedures for the Conduct of Clinical Trials