Northwestern University will serve as a Clinical Center in the APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) (Collaborative U01). Site PI Responsibilities The Site PI will direct the proposed study at the Northwestern University Comprehensive Transplant Center (NUCTC) and interact closely with Drs. Reeves-Daniel, Freedman and other Site PIs to ensure that all aspects of the study proceed smoothly. The Site PI will supervise the local study coordinator and perform clinical recruitment, completion of study and IRB documents. The Site PI will supervise collection and shipment of study specimens to Wake Forest, monitor adherence to project timelines and ensure that the scientific integrity is maintained. The Site PI will provide scientific expertise during the analysis phase involving all U.S. kidney transplantation procedures from African American living and deceased donors and follow-up of living donors for vital status and kidney function based on APOL1 genotypes. He will actively participate in the interpretation of study data and manuscript preparation. Site Study Coordinator Responsibilities The Site Study Coordinator will be responsible for screening and enrolling transplant recipients and living donors, ensuring that protocol requirements are met, and providing follow-up clinical data and outcomes for all local participants throughout the study. The Site Study Coordinator will work closely with the laboratory personnel at the Clinical Center Site to ensure that the appropriate samples are collected and results of research study-related outcomes are provided to the Wake Forest APOLLO Clinical Center at regular intervals, and when necessary to the APOLLO Scientific and Data Research Center. The Site Study Coordinator will also be responsible for assisting the research team with implementation of study data forms and data collection instruments. The Site Study Coordinator will provide oversight for maintenance of regulatory documentation and will work closely with Site PI and the APOLLO Institutional Review Board. The Site Study Coordinator will be responsible for maintaining study documents, coordinating site team meetings, maintaining the Northwestern database (contact info, visit schedules, etc., for all local participants), and coordinating patient appointments with labs and the clinical team.
|Effective start/end date||6/1/18 → 5/31/22|
- Wake Forest University Health Sciences (287-101750-119551//5U01DK116040-04)
- National Institute of Diabetes and Digestive and Kidney Diseases (287-101750-119551//5U01DK116040-04)
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