Grants and Contracts Details
HUMAN CLINICAL TRIAL - CONFIDENTIAL Specifically the ATRI will provide: 1. Participate in the planning and inception of the study including developing and gaining approval of the Protocol. 2. Conduct regular conference calls and coordinate training of site personnel 3. Maintain appropriate IRB approvals 4. Provide regular communication and report on the ongoing progress of the study 5. Provide the overall administration of the project. The main areas of responsibility of the Administrative Core are establishment and maintenance of subcontracts with the sites, tracking visit activities and providing payments for the subcontracts, human subject’s regulatory compliance and consent form development. The Medical Core is responsible for processing clinical and adverse event data. The Clinical Operations Core is responsible for developing, updating and distributing study documents (protocols, training and procedures manuals), coordinating and organizing the clinical trial activities at the sites, tracking enrollment and assigning open enrollment slots, managing and distributing study supplies, acting as the primary point of contact for the sites, and coordinating clinical operations activities including managing clinical site performance and activities. 6. Collaboratively interpret and disseminate study results and activities
|Effective start/end date||6/13/18 → 7/21/22|
- University of Southern California: $25,575.00
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