Study Feasibility Review

Prior to submitting for funding opportunities, the PCORnet Research Committee and Coordinating Center encourage review of proposals (proposed methods, study concepts, and protocols) through our Study Feasibility Review. This process will determine if PCORnet is equipped to answer the study question and if the study is appropriate for the PCORnet infrastructure. Use of the PCORnet Common Data Model, partner networks, and resources will be assessed.

The Submission and Review Process 

Before submitting a request, it is important to familiarize yourself with the types of research PCORnet is suited to address and the resources available through PCORnet to assist with developing, planning, and implementing your study. When completing the PCORnet Front Door Request Form, you will be asked if you want to submit a Data Network Request to obtain preliminary data for a proposal or identify availability of data on a specific patient population. You will also be asked if you want to submit a Network Collaboration Request to identify interested sites or to request investigator expertise.

Image detailing the PCORnet Study Feasibility Review (Pre-Funding) process: Requestor, Front Door, Coordinating Center Review Team, Front Door, and then back to the Requestor. The entire process typically takes approximately 13 days.
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Following an administrative review by the Front Door, your request will be reviewed by the PCORnet Coordinating Center to determine appropriateness for the PCORnet infrastructure. The review process takes approximately two weeks, after which time the Front Door will provide recommendations. Use the downloadable Request Form Template to preview the Front Door request questions and compile your information ahead of time.

Study Feasibility Review FAQs

What types of research is PCORnet suited to address?
  • Pre-research Queries: Including feasibility queries, engagement, and match-making
  • Observational Studies: Including cross-sectional, epidemiological, health services, and comparative effectiveness or safety
  • Interventional Studies: Including clinical trials, pragmatic randomized clinical trials, e-Identification, e-Consent, e-Randomization, e-Follow-up, and cluster randomization

What resources and services are available through PCORnet?

The Coordinating Center will work with requestors to prepare a cost assessment for use of any PCORnet resources and/or services.

  • Access to PCORnet investigator and patient/participant expertise through partner networks and Collaborative Research Groups (CRGs) via a Network Collaboration Request
  • Consultation on creation of a computable phenotype to identify populations of interest
  • Access to the PCORnet Distributed Research Network Operations Center(DRN OC) to obtain aggregated results to inform research project development
  • Data science consultation in the development of PCORnet data network queries to answer research questions
  • Consultation for the use of a Single IRB model and its associated procedures
What criteria are used to determine study feasibility?

To determine appropriateness and feasibility of using the PCORnet infrastructure, the PCORnet Coordinating Center will assess:

  • If the study is people-centered.  See below FAQ for definition of “people-centered”
  • Inclusion of at least one PCORnet Clinical Data Research Network (CDRN) or Patient Powered Research Network (PPRN).  PCORnet currently has 33 partner networks
  • Use of quality-checked data standardized to the PCORnet Common Data Model (CDM) format
  • Use of as many PCORnet resources as possible.  See previous FAQ for details on PCORnet resources
  • How participants/patients are engaged in the design, conduct, analysis, or dissemination of the research. See below FAQs for more details on engagement

The ability for PCORnet to answer the study question and timelines for the funding opportunity will also be considered when determining appropriateness for utilization of the PCORnet infrastructure.

How does PCORnet define “people-centered”?

Consistent with PCORI philosophies and values regarding patient-centered research, PCORnet deems a research activity to be people-centered if it pursues a question that is important to participants/patients, measures outcomes that are noticeable and meaningful to participants/patients, and produces results that help participants/patients weigh the value of healthcare options given their personal circumstances, conditions, and preferences.

Does my study demonstrate participant/patient engagement?

A requirement for subsequent, post-funding PCORnet Study Designation is that the study demonstrate how participants/patients are engaged in the design, conduct, analysis, or dissemination of the research.  Consider the following prompts when describing how your study demonstrates participant/patient engagement:  In what phases of the project are participants/patients involved? Are you working with PPRNs? Advocacy groups? Which stakeholders or groups are you (or will you) be engaging? What components of the research project will they be contributing to? How has your study design been modified by the participant/patient engagement?  For additional information, refer to the PCORI Engagement Rubric for Applicants.

Last updated on March 6, 2018