CRC

Johns Hopkins University, Baltimore MD

Investigators

Linked publications, trials & patents

Abstract

The Clinical Research Review Committee (CRC) of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is responsible for reviewing the scientific merit, priorities, and progress of the clinical protocol research of the center. Committee approval is required prior to opening a protocol in the Cancer Center. The committee also has the authority to close protocols that do not demonstrate adequate scientific progress. Over the past five years, the average number of protocols reviewed per year for scientific merit was 115 protocols. These numbers fluctuate year to year with the lowest being in 2001 (92 protocols) due to the Office of Human Research Protection (CHRP) shutdown. In 2004, 135 studies were reviewed for scientific merit. On average, in 2004 each week the committee reviewed 3 new, never-reviewed studies, 1 resubmitted study with CRC recommended changes, and 1 study for annual progress and performance. In 2004, a new CRC Prereview Committee (preCRC) was formed. The purpose of the CRC Prereview Committee is to facilitate the protocol approval process by providing investigators with early feedback on the quality and completeness of their protocols prior to CRC. In addition, the preCRC focuses on ensuring resources are available to support the trial (e.g., nursing, pharmacy, Specimen Accessioning Core). Having the new committee better allows the CRC to focus on the scientific merit, scientific priorities and progress of the research in the Center. Implementation of the preCRC has made the CRC review more efficient and improves research staff efficiency and data quality when the study opens.