Subproject for fixed-price for "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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