Clinical Urology Research Endeavor: C.U.R.E.

The Clinical Urologic Research Endeavor (CURE) has been performing complex clinical research for over 15 years. Our large, world renowned faculty includes experts in clinical and translational research who have lead investigator-initiated and industry-sponsored trials encompassing the entire spectrum of urologic disease. Our faculty is supported in their clinical research effort by the CURE at the University of Michigan.

The CURE team has placed the University of Michigan on the cutting edge of care for patients with urologic diseases by providing quality control for urologic care, and prospective clinical and translational research. The investment in this resource by the University of Michigan, Department of Urology demonstrates our strong commitment to high-quality clinical research.

Human clinical research requires a high level of expertise and resources due to the increasing complexity of clinical trials research and the often rapid discoveries that need to be studied in retrospective and prospective manners.

CURE TEAM DIVISIONS

REGULATORY

The CURE Regulatory Team ensures regulatory compliance during the conduct of clinical research studies via appropriate management of clinical study documentation as well as actively supporting all regulatory aspects of clinical trials start-up, conduct and close out. The regulatory team works closely with the projects to understand their support requirements and ensure those requirements are delivered according to good clinical practice guidelines and the CURE practice guidelines. The Team manages IRB submissions (Initial Approval, Amendments, Renewals, SAEs, and ORIOs), compliance with sponsor forms, consent documents, IRB compliance, and acts as the liaison with internal and external audits as well as the regulatory liaison between the study team, sponsor and IRB.

RESEARCH COORDINATORS

A team of SOCRA-certified research coordinators work closely with the principal investigators to perform clinical trials research. The coordinators support clinical trials research data management and research support services beginning with pre-trial review and planning through study close-out. The team acts as the study startup liaison, coordinates pre-site visits, eligibility determination, source document development, monitor visits, SAEs reporting and monitoring, patient screening and enrollment, specimen collection, and prepares data safety monitoring report.

DATABASE ADMINISTRATION

The database group develops, manages and maintains clinical and bio-specimen databases. In-house database development allows the research team to work directly with principal investigators to effectively and accurately capture study variables, as well as make necessary changes over time to reflect modifications protocol, the addition of physicians and other changes.

BIOSTASTISTICS

The CURE research group for biostatistical support works alongside the research coordinators, database administration group and directly with investigators to develop and analyze research results. The biostatisticial support encompasses quality assurance of datasets, analysis of data and preparation of manuscripts including writing and editing statistical methods and results. Analyses include significance testing, regression, power, survival and repeated measures analyses.