Grants and Contracts Details
Each participating enrolling Site will follow their currently enrolled subjects pursuant to the protocol. The project period ends as of June 30, 2026 with subject enrollment over a 24 month period and an average of 2 years of follow-up. The maximum follow-up for a subject will be 48 months after date of enrollment. Payment is to be made quarterly for data entered by Enrolling Site in the electronic data capture system. Enrolling Site will receive payment per the study budget for each identified item. All required and by occurrence data forms related to all data-related item must be received and marked as complete in the electronic data capture system for an identified phase or visit as specified in the study operations manual with no existing queries related to Enrolling Site data forms that are generated by the electronic data entry system in order for Enrolling Site to receive payment. Event source documentation and device interrogation media also must be remitted per the operations manual in order to receive payment for an identified phase or visit. All data should be submitted within thirty (30) days of the study subjectâ€™s visit. Payment will not be made for missed follow-up visits or missing tests such as ECGs or echocardiograms. Payment for withdrawn or expired subjects will only be made for satisfactory data entered up to the date of withdrawal or terminal event. Following the final follow-up period and notification of study termination, the Enrolling Site will receive the final follow-up visit amount in addition to reimbursement for any data completed during the final quarter if the following conditions are met: 1) Satisfactory completion by Study subjects according to the study protocol; 2) Satisfactory completion of all study subject data forms per protocol; 3) Satisfactory submission of all pertinent source documentation and test media; 4) Resolution of all data queries and adverse event clarification; 5) Submission of any requested final reports or administrative documents to prime recipient
|Effective start/end date||7/8/21 → 6/30/26|
- University of Rochester: $1,293.00
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