The Rockefeller University Navigation Program: a structured multidisciplinary protocol development and educational program to advance translational research.

ABSTRACT: The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty-four protocols underwent Navigation and achieved IRB approval since the pro

SUBMITTER: Brassil D 

PROVIDER: S-EPMC4074027 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature