wiki:GovernanceMaterials

This page includes information in support of data sharing, goverance and IRB processes for the GPC.

Data Sharing and Governance

All GPC sites have executed the GPC Master Data Sharing Agreement 2014.

Earlier Drafts

One example would be, EGRET, a Medical Informatics Data Sharing Agreement we found that is not too dissimilar from the HERON data sharing agreement used by the University of Kansas Medical Center and its affilated hospitals and clinics.

Another is the HERON IRB protocol.

External Collaborator Agreement

Greater Plains Collaborative Cooperative External Institution Collaborator Agreement March 2015

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SOPs

GPC SOPs (1-12) of March 2015.

Updated SOPs coming soon (May 2017).

GPC IRB ACTIVITIES

The GPC is looking to align our approaches for IRB reciprocity, governance, and Standard Operating Procedures (SOPs) for organizing clinical trial activities with our Clinical and Translational Science organizations and the newly created Midwest Area Research Consortium for Health (MARCH) implementation plan and the SOPs in the attached zip file.

Follow-up items from November 6-7 IRB Meeting in Kansas City, KS. Action Items and Timeframes

  1. Agreement signed by 11/21 with 12/1 effective date – All/Steve? to consolidate

11/26 Update: All GPC sites have signed and returned the agreement. S.Fennel to return fully executed copies to all.

  1. HIPAA templates by 11/14 to Rebecca; draft by 12/1

11/26 Update: Distributed on 11/25 by G. Hughes of CMH on behalf of Rebecca

  1. Web-based platform: Steve and Carol to talk week of 11/17

11/26 Update: GPC Trac site will be used initially

  1. Protocol checklist - before Thanksgiving - Carol
  2. Future use - before Thanksgiving – Karen

11/26 Update: Draft language distributed by K.Blackwell on 11/10/14

  1. Personnel template - before Thanksgiving – Carol
  2. SOP revisions by 11/14 - Carol

11/26 Update: Distributed 11/13

  1. Workflow/flowchart after SOPs complete - December (Michele Countryman)

11/26 Update - Work underway by Michele

  1. Summary sheet for institutions (i.e. institutional requirements)

Template – Karen sent 1st draft Rebecca will suggest template by 11/14; all sites respond by January 1, 2015 11/26 Update: Template distributed for review 11/10

  1. Reliance Checklist – Jan 1, 2015 - Carol
  2. Summary of reliance decision for study teams template (Carol and Vicki) – January 2015
  3. Education materials by next summer (Kim and Rebecca)
  4. Group call after ALS and Breast Cancer to debrief/lessons learned – All sites; Steve to organize
  5. Informed Consent template to Rebecca by Thanksgiving; analysis back by mid-February
Last modified 14 months ago Last modified on May 4, 2017 2:09:27 PM

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