PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
TECHNICAL PROPOSAL TEMPLATE
Please provide the information requested below. Detailed instructions are included in the application guidelines for this PCORI Funding Announcement (PFA).
TECHNICAL STRATEGY
Describe your strategy and plan, in detail, and demonstrate how your proposed project is responsive to this PCORI Funding Announcement (PFA). The template shows
where merit reviewers may expect to find information to evaluate each of the merit review criteria, which are delineated in the PFA. Do not exceed 15 pages. Specific
page limits are indicated below for each section. Replace the italicized text to insert the required response.
PART I: EXECUTIVE SUMMARY (Page limit: 1 page)
Provide an overview of the proposed project, with a brief background on the health plan’s member enrollment and
overlap with existing PCORnet Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks
(PPRNs) for each of the three PCORnet Demonstration Studies and for future research studies with the creation of a
multipurpose data set. Applicants should also include information on the anticipated approach to governance and
oversight for linkage of data and transformation of data into the PCORnet Common Data Model (CDM) as well as the
health plan/system partnership’s proposed approaches for engaging in a collaborative research network.
PART II: TECHNICAL PROPOSAL (Page limit: 14 pages)
Describe specific plans for achieving the requirements for each of the key activity areas.
1. Population Overlap with One or More CDRN Populations (Criterion 1)
 Describe the potential health plan population overlap with populations cared for by PCORnet CDRNs and PPRNs
for each of the three PCORnet Demonstration Studies, potential future studies, and for a multipurpose data set.
 Describe the applicant’s collaborations with the PCORnet Coordinating Center (CC), CDRNs, PPRNs, and
organization leaders. Describe the types of collaborations that have been undertaken to date to assess
population coverage between the health plan and PCORnet CDRNs and PPRNs.
 Describe any previous engagement in similar work to link populations across healthcare settings and timespans
with respect to specific Institutional Review Board (IRB)-approved research studies and multipurpose data sets.
 Provide the required amount of time and effort, full-time equivalent (FTEs), and demonstrate that the study team
has the necessary expertise to conduct the project.
2. Approach to Governance and Oversight (Criterion 2)
 Describe an approach for the linkages to support the IRB-approved PCORnet Demonstration Studies, potential
future studies, and multipurpose linked data sets that is commensurate with the proposed activities, reflects
understanding of human subjects protection requirements, and provides compliant and efficient ways to link
multisite data in compliance with associated IRB, Health Insurance Portability and Accountability Act (HIPAA),
and other applicable requirements.
 Describe an approach for efficiently obtaining appropriate Data-Sharing/Data-Use Agreements and for the
development and implementation of standardized Business Associate Agreements (BAAs), as appropriate,
for the PCORnet Demonstration Studies, potential future studies, and the multipurpose linked data sets.
 Describe an approach to address the challenges related to sharing of individual-level data to accomplish linkages
in a way that results in a high degree of certainty that the data are associated with the same individual, in
compliance with applicable laws.
 Describe current and planned practices, as well as specific technical approaches, for protecting the privacy,
security, and confidentiality of claims data in multinetwork studies, including in-place or planned policies,
PCORI Technical Proposal Template: PCORnet Initiative on Health Plan/System Data Partnerships
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
practices, and agreements to protect data during acquisition, linkage, storage, analysis, and transmission, in
compliance with applicable legal requirements.
3. Technical Merit of Proposed Approach to Data Linkage Activities (Criterion 3)
 Provide evidence that the overall approaches and methodologies in place to accomplish the data linkage
activities can be completed in the specified time frame, with compelling evidence that the proposed data
linkages would augment the data already captured at the CDRN or PPRN, and that is supported by health plan
leadership, as demonstrated by examples from prior work.
 Provide evidence that policies and procedures are already in place for responding to a data breach, including how
affected patients, clinicians, and researchers will be notified, how potential harm will be mitigated, and how any
negative impact on the capacity of the health plan to conduct research will be minimized.
 Provide credible and technically feasible approaches to ensuring non-duplication of patient data between a
network and a health plan (e.g., if there were two beneficiaries with the same name, demonstrate that the
health plan can reliably determine which one received care at a given health system).
 Provide evidence of the capacity and a plan to maintain high-quality analysis-ready data sets mapped to the
PCORnet CDM (e.g., instantiated and implemented data in the Sentinel data model), including demonstrated
ability to ensure that data are complete and consistent and are refreshed quarterly, and that processes are in
place for remedying data errors as needed.
 Demonstrate a willingness and ability to participate in queries related to the three PCORnet Demonstration
Studies and to build the capacity to participate in potential future research studies using the PCORnet Distributed
Research Network (DRN).
 Describe how the health plan would respond to the queries, including the decision-making process for responding
to a query; the centralized or federated technical approach to implementing the query response; and the
software and personnel to conduct these queries as well as more complex analyses using Statistical Analysis
System (SAS) software.
 Describe an approach that will allow for use of follow-up data for consenting participants involved in the
PCORnet Demonstration Studies.
4. Engaging in and Sustaining a Collaborative Research Network (Criterion 4)
 Describe how the health plan might engage in discussions about research activities, both within their plan, in
collaboration with specific CDRNs and PPRNs with whom they are partnering, the PCORnet CC, and with the
broader PCORnet community.
 Describe an ability and willingness to share knowledge and practices with others by identifying areas of expertise,
approaches, tools, and techniques with which the health plan has depth of experience, and by describing policies,
mechanisms, and tools to share and disseminate these approaches, including via the PCORnet Commons.
 Describe a willingness to participate in PCORnet workgroups related to data linkage deemed relevant by the
PCORnet Council and/or Data Subcommittee.
PCORI Technical Proposal Template: PCORnet Initiative on Health Plan/System Data Partnerships
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
PROTECTION OF HUMAN SUBJECTS
For additional guidance, consult Section 5.0, “Human Subjects Research Policy,”1 from the Supplemental Grant Application Instructions for All Competing Applications
and Progress Reports, from the U.S. Department of Health and Human Services. For detailed instructions, consult the application guidelines for your PFA. Do not
exceed five pages.
Describe the protection of human subjects.
1
Available at http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf#5_4_IRB_Approval.
PCORI Technical Proposal Template: PCORnet Initiative on Health Plan/System Data Partnerships
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
CONSORTIUM CONTRACTUAL ARRANGEMENTS
For detailed instructions, consult the application guidelines for your PFA.
Describe the proposed activities that will be performed by subcontracted organizations. Explain the strengths that
these partners bring to the overall project.
PCORI Technical Proposal Template: PCORnet Initiative on Health Plan/System Data Partnerships
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
REFERENCES CITED
For detailed instructions, consult the application guidelines for your PFA. Do not exceed 10 pages.
Following scholarly citation practice, list the source material cited in this research plan.
PCORI Technical Proposal Template: PCORnet Initiative on Health Plan/System Data Partnerships
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PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE):
APPENDIX (Optional)
For detailed instructions, consult the application guidelines for your PFA. Do not exceed 25 pages (does not count toward page limit for Technical Proposal).
PCORI Technical Proposal Template: PCORnet Initiative on Health Plan/System Data Partnerships
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