The major goal of the Clinical Research Resource and Facilities Core is to increase the amount of clinical studies that meet the Good Clinical Practice (GCP) guidelines that are carried out at Charles R. Drew University (CDU): This core will facilitate opportunities for faculty to perform clinical studies on the Clinical Studies Center by: a) Providing a Quality Assurance Manager whose responsibilities will include; (1) assisting investigators to prepare IRB, IND and FDA applications, (2) educating research coordinators/PIs at the onset of their studies to ensure that GCP guidelines are met at the outset, (3) evaluating ongoing clinical studies to ensure that GCP guidelines are met as the study is carried out, (4) providing logistical support for the Data Safety Monitoring Board (DSMB), (5) educating the Community Faculty in regards to GCP guidelines, b) Providing research coordinators to enable studies whose funding does not support a dedicated research coordinator to be carried out; c) Providing Research Subject Advocates (RSA); (1) to ensure that participants are treated fairly and safely; (2) to evaluate their experience as research subjects, (3) to educate community members (not faculty) regarding research and their potential role as participants.
There are many fewer clinical studies in minority populations compared to the Caucasian population. Pathophysiolgy and clinical responses to treatment often differ in these two populations. Less information in minority populations has been shown to have a deleterious effect on health outcomes. A robust Clinical Studies Center at CDU will help repair this discrepancy and contribute to less health dsparities in minorities.
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