PCORnet Bariatric Study

Project: Research project

Project Details

Description

SCOPE OF WORK – LEAD BARIATIC SITE FOR CDRN Year 1 (Project Start up and initial query in 1st 6 months; Aim 1 work in 2nd 6 months): • Scientific leadership o Participate in twice-monthly conference calls over the two years of the project o Provide scientific input on all study activities by email and teleconference o Opportunity to be a co-author on manuscript related to cohort description and Aim 1 results • Operational management: o Issuing subcontracts with node sites o Oversight of regulatory (IRB and any necessary data use agreements) matters with node sites and CDRN-level communication with the study PIs regarding regulatory matters • Query management for initial cohort characterization and Aim 1: o Running study related queries on CDM v3.0 using SAS (expected to be <5 queries in the first year), o Trouble-shooting data quality problems specific to node sites, o Node sites will need to remediate issues with data quality that may be necessary to implement study queries; and • Stakeholder engagement (each CDRN will have 1 paid stakeholder) o Stakeholders will be expected to participate in a once-monthly hour-long teleconference over the full year; and • Travel to Washington, DC for CDRN scientific lead investigator and 1 stakeholder per CDRN o One in-person kickoff meeting at beginning of project (year 1) Year 2 (FIRST 6 MONTHS: Aim 2 work will occur in first 6 months of year 2): • Scientific leadership o Participation in twice-monthly conference calls in year 2 o Providing scientific input on all study activities for Aim 2 by email and teleconference o Opportunity to be a co-author manuscript for Aims 2 • Operational management: o Managing subcontracts with node sites, o Oversight of regulatory (IRB and any necessary data use agreements) matters with node site sand CDRN-level communication with the study PIs regarding regulatory matters; • Query management for Aim 2 (all CDRNs will participate) o Running study related queries on CDM v3.0 (expected to be <3 queries) and o Trouble-shooting data quality problems specific to node sites, o Node sites will need to remediate issues with data quality that may be necessary to implement study queries; and • Stakeholder engagement (each CDRN will continue to have 1 paid stakeholder) o Stakeholders will be expected to participate in a once-monthly hour-long teleconference over the full year Year 2 (SECOND 6 MONTHS Aim 3 work will occur in the second half of Year 2): All CDRNs will be involved in the science, operational, stakeholder, query management, and travel activities below • Scientific leader o Participation in twice-monthly conference calls in year 2 o Providing scientific input on all study activities for Aim 3 by email and teleconference o Opportunity to be a co-author manuscript for Aim 3 • Operational management: o Managing subcontracts with node sites, o Oversight of regulatory (IRB and any necessary data use agreements) matters with node sites and CDRN-level communication with the study PIs regarding regulatory matters; • Query management for Aim 3 o No queries in 2nd 6 months • Stakeholder engagement (each CDRN will continue to have 1 paid stakeholder) o Stakeholder will be expected to participate in a once-monthly hour-long teleconference over the full year • Travel to Washington, DC for CDRN scientific lead investigator and 1 stakeholder per CDRN o One in-person meeting at end of project
StatusFinished
Effective start/end date2/1/161/31/18

Funding

  • Chicago Community Trust (Agmt Signed 8/11/16)
  • Patient-Centered Outcomes Research Institute (Agmt Signed 8/11/16)

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