CMMI Human Subject Research Enhancement Program

Ctr For Molecular Medicine/Immunology, Belleville NJ

Investigators

Abstract

With the exponential growth of human subject research and the continuing expansion of new technologies, it is essential that IRBs have on-going training and tools that will enable them to perform their assigned tasks to the highest level of proficiency. A vital component to the continuing review of clinical trials is a strong monitoring program. An integral component for this program is a database that is used to track the progress of each study. In this regard, the specific aims of this application will be the following: l .) The development of a secure networked database that will be used to assist the IRB and clinical monitoring program in tracking the progress of clinical trials sponsored by our institution. Tracking elements will include such items as documentation of informed consent, protocol and investigator brochure amendments, adverse event listing, serious adverse event notifications, monitoring visits, verification and collection of case report forms, submission tracking (i.e., submission of initial and annual reports to IRB, Radiation Safety Committee, FDA, Data Safety Monitoring Committee), training documentation, etc. 2.) Set up of a new application server to host the database. This will become an integral part of receiving information from CMMI clinical trials within this institution and among affiliated institutions through the use of virtual private networks (VPN). 3.) Provide travel expenses and educational materials for IRB members, investigators, and Regulatory Affairs Office personnel to attend meetings for educational enhancement.