Grants and Contracts Details
1. Designation of a study coordinator and all other necessary personnel to accomplish the project. 2. Completion of required regulatory documents (e.g., local IRB Reliance agreement, radiotracer regulatory documents). 3. Meeting of agreed-upon enrollment of research participants. 4. Selection of new subjects to meet objectives for minority recruitment as detailed in the ADDORE Core. 5. Implementation of retention program to ensure that the dropout rate does not exceed 5% per year (with the exception of participant death). 6. Study coordinator attendance on regularly scheduled coordinator conference calls and clinical performance site PI attendance on regularly scheduled Clinical Core calls. 7. Full compliance with all procedures specified in the protocol and in the procedures manuals (e.g., imaging procedure manual, blood-based bio-specimens laboratory manual, neuropsychology assessment manual) 8. Full compliance with the specified inclusion/exclusion criteria cited in the protocol. 9. Ensuring proper informed consent as cited in the protocol. 10. Carry out all evaluations within the time limits specified in the procedures manual for the protocol. 11. Proper completion of electronic submission of all clinical, imaging and biomarker data, required data correction, and patient activity reporting within the limits specified in the procedures manual. 12. Collection, processing, storage and shipment of laboratory specimens for adequate biomarker samples within the time limits and conditions specified in the protocol and procedures manual. 13. Training of all study personnel and proper administration of all assessments. Timely notification of personnel changes with accompanying training documentation. 14. Timely notification of AEs and/or SAEs, as detailed in the protocol and procedures manual. 15. Availability of study personnel to the clinical monitors during on-site monitoring visits and access to subject notebooks, source documentation, and clinic charts if they exist. 16. Prompt response to request (administrative or data-related) from the ABC-DS Administration (e.g., information required for DSMB reports or annual NIA reports).
|Effective start/end date||9/30/20 → 8/31/21|
- University of Pittsburgh: $601,165.00
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