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UR CTSI

UR CTSI. UR CTSI RKS. Regulatory Knowledge and Support Key core within the UR CTSI Lead by a Director (TBN) Staffed by/with Patient advocate program Quality improvement / consultation / audit program Research administrative support Coordinates on behalf of PI with

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UR CTSI

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  1. UR CTSI

  2. UR CTSI RKS • Regulatory Knowledge and Support • Key core within the UR CTSI • Lead by a Director (TBN) • Staffed by/with • Patient advocate program • Quality improvement / consultation / audit program • Research administrative support • Coordinates on behalf of PI with • IRB, grants management, tech transfer, etc.

  3. RKS Specific Aims • To ensure that CTSI researchers are trained in the science and ethics of CTSI-related human subjects research in order to optimize study design, regulatory review and the informed consent process. • To conduct quality improvement activities and provide onsite guidance to CTSI researchers and to assist decision-makers to determine state of compliance. • To develop an educational and assistance program (computer-assisted as well as in-person help) to assist CTSI researchers in developing regulatory review submission documents and informed consent forms for CTSI-related projects. • To ensure that conflicts of interest are eliminated or managed appropriately for all CTSI research. • To provide integrated training, support and information.

  4. UR OHSP • Investigator Training • mandatory • Quality Improvement / Consultation / Audit • On request / by assignment (IRB) / routine • Electronic Application System • Computer support / business management • IRB (Research Subjects Review Board) • Ethical review

  5. UR OHSP • IRB (RSRB) • 4 on-site IRBs (CTSI IRB may be # 5) • Contract IRB (WIRB) (phase 3 sponsored CTs) • Secondary review mechanism with RGH • Many cooperative review agreements • UNYTRN collaborative IRB (lead IRB model)

  6. UNYTRN • Upstate NY Translational Research Network • RKS activity • Collaborative IRB review model • Model MOU for FWA amendments • Collaborative web site to post reviews / comments • UNYTRN IRB Educational activity (CY 2008)

  7. Next Steps • Hire Director RKS (in 2nd round interviews) • Hire QI/C/A (strong candidate identified) • Begin Computer Program design and implementation

  8. Links • http://www.urmc.rochester.edu/ctsi/ • http://www.foundationforhealthyliving.org/unychrq.php • http://www.urmc.rochester.edu/ohsp/

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