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Greater Plains Collaborative CDRN Collaboration

The GPC Front Porch Resource Guide is a compilation of key GPC resources and will provide a one-stop shop for investigators.  The Resource Guide is aimed to help the investigator determine the types of services that they need in their engagement with GPC.  Please click this link Front Porch Resource Guide for the descriptive version. 

A list of GPC collaboration activities includes, but is not limited to, the following:

  • Development and validation of computable phenotypes (algorithms to identify patients)
  • Prep to Research activities such as obtaining counts for feasibility or sample size estimates
  • Research on de-identified and limited electronic health record data
  • Identification of patients across the Greater Plains Collaborative CDRN
  • Contact of potential study subjects through phone, email, and other modalities
  • Survey Research
  • Observational research
  • Pragmatic clinical research
  • Hypothesis Generation
  • Stakeholder Engagement (Patients/Families, Clinicians, Clinics, etc)
  • Health Information Technology support for patient-facing studies
    • Electronic survey
    • Electronic payment
    • Electronic decision support for trial delivery

1.1  Types of Investigator Resources

GPC provides a variety of data, analytic, engagement, and administrative services that support academic investigators at different research stages. From feasibility counts to full-scale nationwide collaborations, we have a customized menu to meet the scientific and budgetary needs of K-R proposals and projects (Figure 1). GPC boasts a unique data source, the GPC Reusable Observable Unified Study Environment (GROUSE) – a de-identified data resource, which is created by merging Medicare and Medicaid claims with Electronic Health Records from all 13 GPC sites in PCORnet Common Data Model format. GROUSE enables investigators to answer research questions without being limited to one healthcare institution. Three pre-defined cohorts are currently covered by GROUSE IRB for using CMS claims for research purposes: Breast Cancer, Amyotrophic Lateral Sclerosis (ALS) and Obesity. Additional information regarding GROUSE can be found in Section 3.2.

2.1.1. Data and Analytic Services

Electronic Health Record Data/ PCORnet Common Data Model

The PCORnet Common Data Model (CDM) is a specification that defines a standard organization and representation of data for the PCORnet Distributed Research Network. The PCORnet CDM is a key component of the PCORnet Distributed Research Network (DRN) infrastructure.  PCORnet developed the PCORnet DRN to be a “...functional distributed research network that facilitates multi-site patient–centered research across the Clinical Research Networks (CRNs) and other interested contributors. The distributed network will enable the conduct of observational research and clinical trials while allowing each participating organization to maintain physical and operational control over its data”. [Data Standards, Security, and Network Infrastructure Task Force (DSSNI charter), 2014]

For rich detail on the current common data model specification, please visit https://pcornet.org/data/ or download the latest CDM specification: https://pcornet.org/wp-content/uploads/2023/04/PCORnet-Common-Data-Model-v61-2023_04_031.pdf

In addition to the standard tables, GPC has greatly enhanced site data with specialty tables such as mortality data, cancer data and clinical textual notes. Please see Appendix 2 for more information.

Proposal Development

Feasibility query: A Feasibility or Prep-to-Research Query can be submitted through the Data Request and Oversight Committee (DROC) to request these patient counts for the specific study Aims of the investigator at the proposal development stage. Feasibility queries are typically provided to investigators at no cost. These queries be distributed and run at individual GPC sites or can be run using GPC’s federated environment. GPC sites can review these queries and determine whether or not they would like to participate in this proposal submission.  Please refer to Table 1 for process summary and section 3.1 for DROC process details.

Funded Project

1. Distributed Data from GPC sites.

  • Definition: sites receive simple well-defined SAS/SQL/R queries for a well-defined cohort(s) and return results to investigator
  • Data (researcher gets these data delivered to them)
    • Aggregated CDM data for feasibility counts or macro analysis of cohort(s) 
    • De-identified line-item CDM data for cohort analysis
    • Limited data set CDM data extraction and linkage for site-level cohorts <150K
    • Limited data set CDM data extraction and linkage for site-level cohorts >=150K and/or additional specialty non-CDM data table(s)
  • Analysis
    • GPC hub site research team develops and tests queries in SAS, SQL, R against PCORnet CDM to be executed by all or selected sites
    • Note:  Co-investigator support: inclusion of experienced GPC Co-I effort is strongly recommended for Analysis requests

2.  Federated Data from GROUSE New Data and Analysis (Investigator accesses data and writes their own code against it using SAS, SQL, R; Figure 2). For more GROUSE information, please see Appendix.

  • CDM Only (Ruffed GROUSE) for all GPC sites
  • CDM + Medicare Claims (Sage GROUSE) for all GPC sites
  • Data reuse: re-purpose previously extracted distributed/federated data for a new study. Might require GPC Governance Council approval. The Research Opportunity Assessment (ROA) process is the initial step for investigators to collaborate with the GPC research network. This process is used to better understand your research and the ways in which you would like to collaborate with the GPC sites. Please refer to section 3.2 for more ROA process information.

GPC maintains a highly active IRB advisor group. Prior to the submission of a grant application or project proposal of a multi-center project, it is recommended the principal investigator discuss the proposal/project with an IRB representative from their institution or the GPC IRB group to determine the regulatory path and if IRB review is appropriate, and/or the type of IRB is needed.   

 

 

Table 1: GPC Data/Analysis Product Summary

 

Mechanism to submit request

Who is responsible for query development?

How are results accessed?

 

Timeline

IRB approval

Distributed Data

 

 

 

 

 

Aggregate Query

DROC

Investigator in collaboration with the informatics/analyst at local site, GPC central or PCORnet query fulfillment center. Piloting at a site and validation is required.

REDCap or CSV

2-3 weeks without query optimization

Not required

De-identified

DROC/ROA

Same as above 

REDCap

Same as above

Non-human subject determination letter from IRB

Limited < 150

ROA/DROC

Same as above

REDCap

Same as above

Required – needs to be uploaded in request forms

Limited >= 150

ROA/DROC

Same as above

REDCap or SFTP

Same as above

Required – needs to be uploaded in request forms

Analytic Services

 

 

 

 

 

Access to GROUSE data for investigator to conduct analyses

ROA/DROC

 

Queries developed and confirmed with a GPC GROUSE expert

Within GOUSE environment

2 weeks upon DROC approval

Required – needs to be uploaded in request forms

GPC team conducts analyses on GROUSE

ROA/DROC

 

Queries developed and confirmed, results analyzed by a GPC GROUSE expert

Within GOUSE environment

2-3 weeks

Required – needs to be uploaded in request forms

Note:  Aggregated queries can be provided with no costs; costs of other services will be determined during consultation

 

 

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Figure 1. Services Corresponding to Funding Level

 

For more detailed information on GPC Collaboration pricing as well as letters of support, please refer to the following presentation, which also includes specific rates associated with the various activities as well as examples of cost breakdown for various types of collaboration:

Greater Plains Collaborative Pricing Breakdown

 

 

Submitting Grants Leveraging the Greater Plains Collaborative CDRN

Please feel free to use the following templates for Letters of Support, Grant Submissions leveraging the GPC, and Budget Justifications for developing your GPC CDRN project proposal budget. 

Data Request Information

Site Level Data Characterization

  • All GPC sites participate in the PCORnet Common Data Model (CDM). Portions of each sites data characterization report have been uploaded on our site level data characterization page. This will give researchers an overview of the data at each site. 

GROUSE Information

  • GROUSE (Greater Plains Collaborative Reusable Observable Unified Study Environment) is a GPC project to obtain health insurance claims, please visit our GROUSE page to learn more about this rich data. 

I2B2 Information

  • All sites in the Greater Plains Collaborative have an i2b2 based repository. The University of Kansas Medical Center has numerous trainings. Please see our Guide to using HERON.

IRB Information 

All of our GPC institutions have signed on to SMART IRB.

SMART IRB Participating Institution

 

 

PCORnet Collaboration

In order to understand the total PCORnet collaborators available, please open this link

Collaboration as a Patient

The Greater Plains Collaborative is funded by the Patient-Centered Outcomes Research Institute, and as such we are always trying to involve patients in our activities as much as possible. We need patient collaborators to attend our events, help plan our studies, and to guide the direction we take as a network. If you are a patient who wishes to collaborate with the GPC as a Patient Advisor, please visit our Patient Resources page to see ways you can get involved.

GPC Logos to Download

GPC Process Flowcharts