MESA

Project: Research project

Project Details

Description

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.
StatusActive
Effective start/end date10/1/209/30/21

Funding

  • Columbia University (PRESPEND)

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