Proactive Infrastructure for Human Subjects Protection

Thomas Jefferson University, Philadelphia PA

Investigators

Linked publications & trials

Abstract

In this application, Thomas Jefferson University (TJU) proposes to build on the success of two pilot programs, one in clinical trials in oncology and the other human subjects protection, to provide real-time, secure Internet access to clinical trials information to investigators and their staff, university officials, Division of Human Subjects Protection (DHSP), and others responsible for the protection of human subjects and monitoring of clinical trials. Thomas Jefferson University IFIBs are approved under Federal Assurance 00002109. During the 12 month period ending March 2002, the IRBs reviewed a total of 882 new submissions. There are currently 1050 active studies. A currently operating pilot program for data tracking of TJU's Kimmel Cancer Center (KCC) oncology trial activity will be merged with the human subjects protection database and the resulting merged program expanded and updated to track university-wide clinical trial activity and human subjects ]rotection. It will be coupled to a DHSP quality improvement/education program that functions in conjunction with the continuing review process. This expanded tracking system will also include a merger of the IRB and KCC systems for adverse event reporting into a university-wide system for the on-line submission and monitoring of all TJU clinical trial adverse events. In its entirety, the proposed project will provide an important management tool for Thomas Jefferson University in its commitment to human subjects protection.