This proposal requests support for three projects designed to enhance human subjects research protections at the Fred Hutchinson Cancer Research Center (FHCRC). Once implemented, the FHCRC will provide support for continued implementation of these enhancements. These projects are: 1. Enhancing Human Subjects Assurances in Multi-Site Studies This project will review and improve human subjects protection systems for studies that are conducting multi-site trials or studies that involve unaffiliated investigators, including non-domestic sites. We will conduct a review of policies and procedures for managing multi-site trials and will develop and evaluate tools to enhance the ability of a coordinating center and sites to meet OHRP requirements. 2. Training Program in Good Clinical Practice (GCP) This project will bring all current staff to a uniform high level of training in Good Clinical Practices (GCP) and establish a mechanism for on-going training that will be managed in the future by the FHCRC. A web-based training course will support quality, consistency, and compliance in clinical research studies and help ensure that clinical studies are conducted in compliance with applicable regulations. 3. Protocol Management System This project will develop a web-based protocol management system that will provide uniform and up-to-date information regarding the performance of clinical trial protocols. The system will electronically record and update information associated with human subjects research protocols and will provide uniform and up-to-date information regarding clinical protocols to all committees and staff with oversight responsibility.
| Braunschweiger, Paul; Goodman, Kenneth W (2007) The CITI program: an international online resource for education in human subjects protection and the responsible conduct of research. Acad Med 82:861-4 |
| Leung, M K; Boer, H H; van Minnen, J et al. (1990) Evidence for an enkephalinergic system in the nervous system of the pond snail, Lymnaea stagnalis. Brain Res 531:66-71 |
