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:
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.
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.
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 |
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 |
Same as above |
REDCap |
Same as above |
Non-human subject determination letter from IRB |
|
Limited < 150 |
Same as above |
REDCap |
Same as above |
Required – needs to be uploaded in request forms |
|
Limited >= 150 |
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 |
|
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 |
|
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
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:
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.
All of our GPC institutions have signed on to SMART IRB.
In order to understand the total PCORnet collaborators available, please open this link