The Clinical Research Support Office
) seeks to serve patients in the global community by providing sound administrative and financial infrastructures to support the finest integration of patient care, education, and research while respecting the needs of the human subject. The CRSO participates in the development of institutional policies regarding clinical research, provides training and education to study teams and the clinical research community at Duke, and reviews and approves charge assignment grids. To learn more about the CRSO, click here: http://crso.som.duke.edu/
Watch For These Changes
Time to Start Preparing for eResearch, our Clinical Trials Management System
eResearch, a clinical trials management system, was introduced to the Oncology SBR as a first release in October of 2007. A second release is scheduled for introduction to all remaining SBRs over the next several months. CRSO and IT Support will be working with the SBRs to make this system available to all study teams. SBRs will play a vital role in the implementation of this new system.
for further information on the Clinical Trials Management System and preparations for its implementation.
ClinicalTrials.gov Study Registration
September 27, 2007
, Congress enacted U.S. Public Law 110-85, changing the requirements for listing a study in ClinicalTrials.gov. Research projects are required to be registered if they prospectively assign human subjects to an intervention and at least one concurrent control or comparison group to study the cause-and-effect relationship between a medical intervention and a health outcome. This act also establishes penalties for not listing a trial.
For more information on this act and what it means for you and your study, or to establish a user account for registering studies, please contact Rebeka Branagan at firstname.lastname@example.org or 668-2579.
Revised IRB Requirements for Research Ethics Education
IRB requirements for education on the protection of human subjects have been revised. The goal of this revision is to automate the process of providing information to the IRB, to provide automatic notification when renewal is required, and to redefine the education requirements. A major part of this revision is that, by
January 1, 2008
, anyone listed on new or approved IRB protocols must have completed 2 of the education modules available through the Research Ethics Education and Resources website between
July 1, 2007
December 31, 2007
Additional information on these changes can be found on the IRB website.