Scope of Work: Northwestern University • Start-up o Obtain IRB approval (local IRB or via sIRB, depending on current cohort IRB approval) and other necessary approvals for Phase 1 protocol o Participate in staff training and certification • COVID-19 Questionnaires o Administer wave 1 questionnaire, plus QC o Administer wave 2 questionnaire, plus QC o Administer wave 3 questionnaire, plus QC • COVID-19 Events o Obtain medical records relating to COVID-19 health care utilization (doctor’s notes if possible, ED visits if possible, hospitalizations, deaths), including treatment, severity, outcomes and, if feasible, imaging o De-identify and transfer records to DCC (Columbia) or study coordinating center (if direct DCC transfer not permitted) o Participate in centralized adjudication of events • Biospecimens o Mail dried blood spot kits to participants with telephone follow-up (can be timed with questionnaire), plus QC samples o Telephone training for DBS completion (30 minutes per participant) • Results reporting o Provide results of COVID serology testing and any other clinically relevant results to participants • Scientific output and next steps o Participate in and lead papers and results reporting o Collaborate to design and/or implement Phase 2 activities and ancillary studies. Scope of Work: Cohort-specific Coordinating Center • Start-up o Confirm IRB approvals and/or organize sIRB approval for all cohort sites, depending on current cohort IRB approval, and other related approvals (eg DMDAs). o Build necessary study infrastructure for questionnaire administration, completion tracking, QC, and biospecimen tracking using standardized (prospectively harmonized) ontology o Collaborate to finalize Phase 1 protocol including data transfer, QC and analysis plans. • COVID-19 Questionnaires o Transfer de-identified data securely to DCC weekly • COVID-19 Events o Abstraction and adjudication of events data per DCC protocol if cohort is not able to have these functions performed at DCC • Biospecimens o Provide labels for biospecimens as per Central Lab specifications • Reports o Generate cohort-specific and site-specific reports of study progress, milestones completion and QC using standard format and provided at least weekly to the DCC and Coordinating Committee. Scope of Work: Phase 2 Coordinating Committee members (5% FTE per cohort annually) • Ongoing o Participate in monthly meeting o Communicate and coordinate with sites cohorts • Phase 1 Proposal Finalization and Execution o Finalize and approve study protocol for Phase 1 o Coordinate phase 1 start-up and execution, including pilot activities and tracking of study progress. • Phase 2 Proposal Development o Develop and finalize study protocol for Phase 2, including Phase 2 pilot activities.
|Effective start/end date||10/1/20 → 2/29/24|
- Columbia University (12(GG015997-03) // RTI 22-312-0217571-66178)
- National Heart, Lung, and Blood Institute (12(GG015997-03) // RTI 22-312-0217571-66178)
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