The Accelerating Excellence In Translational Science (AXIS)Charles Drew University of Medicine and Science

Facilitating the Initiation of Research Studies
There are two ways to help investigators set up research studies at Charles R. Drew University. There are a number of forms that must be filled out, e.g., Institutional Review Board (IRB), Occupational Health and Safety Committee (OHSC), Institutional Animal Care & Use Committee (IACUC) and the Radioisotope Committee, depending on the study. Some clinical studies are carried out at other institutions as well which requires the study to be approved by their IRB. The first way to facilitate establishing research status is to provide a common face sheet for all of the potential forms that may need to be filled out. This will eliminate duplication of effort. A more ambitious goal is to harmonize the IRB application from the several organizations that may be involved in a study so that not only will one IRB application will be acceptable to both institutions but the requirements of both are the same. Both of these approaches are being explored.

Role of the Quality Improvement Monitor
The Quality Improvement Monitor will review ongoing research studies to ensure patient safety and identify potential regulatory issues that if not corrected and were to be discovered by an external audit might compromise continuation of the study. As part of that process, the Quality Improvement Monitor provides ongoing education to research coordinators, and if necessary, subsequently to Principal Investigators. An additional contribution is to suggest background educational materials for carrying out clinical research and various forms that might facilitate the collection of appropriate information and, in some instance, meet regulatory requirements. This material can be found under Documents.

Role of the Research Subject Advocate
The Research Subject Advocate interviews subjects who have participated in research studies carried out at CDU with a standard questionnaire to evaluate their experience as participants in these human research studies. The purpose is to gather information that will enhance the human research environment at the University. To the extent possible considering scheduling problems and locations, s/he will observe the research coordinator or the PI obtain an informed consent to ensure that the process meets regulatory requirements and that the subject understands the study which is under consideration.

Data Safety and Monitoring Board
As part of protecting subject safety, the Regulatory Core will house and support the Data Safety Monitoring Board at Charles R. Drew University. The major function of this body is to track adverse events that may occur in subjects during their participation in research studies to assure their safety.

A sponsor or investigator may include as part of their plan a Data Safety Monitoring Board (DSMB). A DSMB is an impartial, independent group developed according to specific guidelines to review the progress and results of a clinical research study. Unique to the DSMB is the ability to view un-blinded data for the entire study to consider the overall picture, including primary and secondary analyses relative to safety. Based on this assessment, the DSMB usually recommends continuation of a study, but may recommend early termination due to positive efficacy or an unfavorable benefit-to-risk ratio. The DSMB will receive reports at convened committee meetings on the studies in which a DSMB has been proposed by the PIs to the IRB at the schedules stated in the approved IRB applications.

DSMB Charter