Subaward 12145ARC179 — AMERICAN NATIONAL RED CROSS, THE under VITALANT

ARC WILL PROVIDE DE-IDENTIFIED ARC DONOR DEMOGRAPHIC AND INFECTIOUS DISEASE TESTING DATA AS REQUIRED IN THE TTIMS STATEMENT OF WORK, PROVIDE BIOSPECIMENS FOR THE REPOSITORY AND RESEARCH TESTING AT VRI, AND WILL ACTIVELY COLLABORATE IN THE ANALYSIS, INTERPRETATION, AND REPORTING OF FINDINGS IN TTIMS. ARC’S PRINCIPAL INVESTIGATOR WILL OVERSEE ALL ASPECTS OF THEIR SITE’S PARTICIPATION IN TTIMS, INCLUDING ACQUISITION OF DONOR DATA AND BIOSPECIMENS AND WILL PARTICIPATE IN CALLS AND MEETINGS FOR THE TTIMS PROJECT. THEY WILL RESPOND TO REQUESTS REGARDING DATA QUALITY ASSURANCE AND QC. PROVISION OF DONOR/DONATION DATA AND ADDITIONAL TESTING WILL BE CONDUCTED ON DEIDENTIFIED SAMPLES MEETING THE EXPECTATIONS FOR PUBLIC HEALTH SURVEILLANCE. VRI WILL PROVIDE THE NECESSARY CRYOVIALS AND SAMPLE STORAGE TUBES TO THE ARC. ARC STAFF WILL PREPARE THE REPOSITORY ALIQUOTS AND SHIP DIRECTLY TO VRI. ARC STAFF WILL PROVIDE TO VRI 5 X 1 ML PLASMA SAMPLES IN 2 ML CRYOVIALS AND A SINGLE CONICAL CRYOVIAL CONTAINING 5 ML PLASMA FOR EACH TTIMS 3 QUALIFYING DONATION. ARC WILL COORDINATE SAMPLE SHIPMENT WITH DESIGNATED VRI STAFF. ARC WILL SERVE AS THE TTIMS DATABASE COORDINATING CENTER FOR THE PERFORMANCE PERIOD, TO INCLUDE DATA COORDINATION FOR ALL PARTICIPATING BCOS, DATA MONITORING, DATA ANALYSES, APPROVED DATA ANALYSIS REQUESTS, REPORT GENERATION FOR DELIVERABLES AS WELL AS INTERNAL AND EXTERNAL PRESENTATIONS/PUBLICATIONS, AS APPROVED BY THE STEERING COMMITTEE AND/OR FDA CLEARANCE WHERE APPROPRIATE. ADDENDA TO THE ARC’S SOW WILL BE DEVELOPED IF OPTIONAL RESEARCH PROTOCOLS ARE FULLY DEFINED AND APPROVED BY THE TTIMS STEERING COMMITTEE.