CITR is a clinical Registry for islet transplantation and total pancreatectomy. The Clinical Site will register and follow, according to the CITR Protocol schedule, recipients of human allogeneic or autologous islet transplantation, pancreatectomy without transplantation, and islet xenotransplantation into humans, until the site no longer follows their islet recipients, or when the end of this agreement’s period of performance is attained. Data on donors and islet product will also be reported by the Clinical Site to CITR. The Study Coordinating Center may provide reimbursements to the Clinical Site in exchange for its completion of the required certification process and subsequent enrollment in the Study, as well as for reporting of study data. For sites reporting data through Emmes’ data entry portal, eClinical®, the reimbursement terms are specific to this agreement with the named Clinical Site and are outlined in the Deliverables and Payment Schedule, Attachment A, which is attached hereto and incorporated by reference herein. For sites with data retrieval by Emmes-staff during an on site visit, there will be no reimbursement for data reporting. For sites providing data by electronic data transfer, the reimbursement for data reporting will be a custom Attachment A (provided herein, as applicable.) The Clinical Site is authorized to proceed immediately with the Level I and II certification process as outlined in Attachment A. The Clinical Site shall not enroll any new study participants until the Clinical Site obtains its local or Central Institutional Review Board (IRB) approvals for the Study protocol and applicable consent documents (and recruitment materials, if used).
|Effective start/end date||9/26/19 → 6/30/21|
- The EMMES Corporation (Agmt 10/1/19 // 1UC4DK114839-01)
- National Institute of Diabetes and Digestive and Kidney Diseases (Agmt 10/1/19 // 1UC4DK114839-01)