(PaCR): Applicant Town Hall Kimberly Marschhauser, PhD Program - - PowerPoint PPT Presentation

Kimberly Marschhauser, PhD

Program Officer

Angela Hvitved, PhD

Merit Review Officer

Rhonda Stewart

Contract Administrator

Jason Gerson, PhD

Senior Program Officer

Partnerships to Conduct Research within PCORnet (PaCR): Applicant Town Hall

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Agenda

Programmatic Overview Letters of Intent and Full Application​ Merit Review​ Administrative Requirements Data Management and Data-Sharing Resources/FAQs​

Submitting Questions Submit questions via the chat function in GoToWebinar

Programmatic Overview

Kim Marschhauser, PhD

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PaCR: Overview

• Objective​:
• This limited funding opportunity is the next step in PCORI’s intentional strategy

to achieve the Board’s vision of a sustainable national research infrastructure that attracts a diverse set of public and private funders of research

• Aims:​
• To promote PCORnet sustainability through collaboration and engagement with non-

PCORI co-funders in the conduct of clinical comparative effectiveness research (CER)

• To promote greater completeness of PCORnet data through linkages of electronic data

with that of health plans, disease registries, and other complementary data sources ​

Eligibility and Budget

• PCORI seeks to fund up to two high-quality clinical studies to answer important patient

and stakeholder-prioritized CER questions

• PCORI is soliciting applications from Clinical Research Networks (CRNs) or Health Plan

Research Networks (HPRNs) continuing to be funded as part of PCORnet 2.0

• Each CRN or HPRN is eligible to submit one LOI

Project Budget:

• Up to $2 million in direct costs
• Up to $6 million in total costs

Project period: Maximum of 3 yearsars

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Specific Requirements

• Partner Funding:
• Applicants will be required to secure 50% partner funding (which may include in-kind

resources) from federal, industry, and other nonfederal co-funders (e.g., health plans, health systems, advocacy organizations) prior to submitting the full application

• Letters of Support:
• Applications need to provide strong, convincing letters of support from co-funders

(due with the full application)

• Demonstrate a clear understanding of the project and a detailed description of the

contributions in terms of funding and in-kind services

• Co-funding partnerships must demonstrate potential for additional future

partnerships/collaboration with PCORnet

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Specific Requirements

• Data Linkages:
• Promote greater completeness of PCORnet data through linkages of EHR/clinical data

with claims data, disease registry, or other complementary data source

• Applicant CRNs and HPRNs are required to use the PCORnet 2.0 Common Data

Linkage Method, if available

• Stakeholder-driven Priority Topic:
• Applications must address stakeholder-driven priority topic area with a CER question

PCORnet Infrastructure Comprehensive and Complete Data

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Leveraging Existing Resources

• Coordinating Center
• Collaborative Research Groups (CRGs)
• Streamlined IRBs, contracting,

engagement, and consenting processes

• PCORnet’s Common Data Model (CDM),

where applicable

• The Commons
• CRNs
• Data sources other than PCORnet
• Registries
• Health Plans
• CMS
• PPRNs

Letters of Intent

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Noncompetitive Letters of Intent (LOIs)

• Submission of a noncompetitive LOI is required for this PCORI Funding Announcement
• A Letter of Support from the PCORnet 2.0 Steering Committee is required with the LOI

submission

• While LOIs will not be competitively screened, all information outlined in the PFA's LOI

template is required

• A Principle Investigator (PI) can submit only one LOI
• Each CRN or HPRN may be the lead PCORnet affiliation for one LOI

Due Date for LOI Submission: May 13, 2019 by 5 p.m. ET

Full Applications

Development of the Research Strategy

• Complete guidance can be found in the PFA and in the Research Plan Template. The following

are key pieces to keep in mind during Research Strategy development:

• Identify and justify all participating research network entities (e.g., health plans,

consortia projects, disease registries, etc.). For PCORnet, identify the names of participating CRNs, PPRNs (if appropriate), HPRNs, their affiliated study performance sites, and PCORnet Collaborative Research Groups (CRGs) that will be collaborating on the project

• Demonstrate that the proposed data source(s) can comprehensively capture the study

variables needed to assess the interventions, covariates, and outcomes

• Describe how you will link and manage data using the PCORnet Common Data Linkage

Method (if available) across proposed study sites, research consortia, and/or other collaborating organizations and whether you will use any dedicated data-coordinating functions or facilities

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Research Team and Environment

• Complete guidance can be found in the PFA and in the Research Plan Template. The following are

key pieces to keep in mind during Research Team and Environment development:

• The research team’s capabilities to accomplish the goals of the proposed research project and

the appropriateness of the research environment to conduct the study

• How and why each research site was selected and how those sites tie back to the research

project

• If multiple sites are involved, prior experience that demonstrates the likelihood of working

together successfully (e.g., past data sharing, IRB reciprocity, or other factors) to facilitate efficient conduct of the study

• How sites will work together to ensure that milestones will be achieved
• Logistical support, such as administrative management and oversight, and best practices

training

Patient-Centeredness Patient Engagement

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Patient-Centeredness and Patient Engagement

• Research questions and outcomes

reflect what is important to patients and caregivers and consider patient preferences

• Project includes active

engagement among scientists, patients, and stakeholders

• Projects includes community,

patient and caregiver involvement

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Dissemination and Implementation Potential

• Complete guidance can be found in the Application Guidelines and in the Research Plan
• Template. The following are key pieces to keep in mind during Dissemination and

Implementation Potential development:

• Identify who will make decisions or use the findings produced by this study, such as local

and national stakeholders

• Describe a plan for disseminating study findings outside of PCORnet beyond publication

in peer-review journals and at national conferences

• Present a credible plan through which findings could be feasibly disseminated and

implemented quickly within PCORnet (including at the local hospital or clinic level and at the leadership level including health systems leaders and clinical leaders), resulting in improvements in healthcare system, practice and patient outcomes

• Clearly outline the roles of patient and stakeholder partners (including health systems

leaders and clinical leaders) in the planning of disseminating the study’s findings

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Consortium Contractual Agreements

• Complete guidance can be found in the Application Guidelines and in the Research

Plan Template. The following are key pieces to keep in mind during Consortium and Contractual Agreements development:

• Describe the proposed research projects that subcontracted
• rganizations will perform: Explain the strengths that these partners bring to

the overall project to ensure successful submission of contract deliverables in accordance with the milestone schedule

• The prime applicant is responsible for the project and must adhere to

the contract’s terms and conditions. The prime applicant should negotiate his

• r her subcontracts accordingly
• PCORI does not require signed subcontract agreements at the time
• f application submission

Merit Review Angela Hvitved, PhD

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What happens to your application after you submit it?

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Administrative Screening

Applicants must follow the administrative requirements stated in PCORI’s Application Guidelines. Applications may be administratively withdrawn for the following reasons:

• Exceeding budget or time limitations
• Not using PCORI’s required templates
• Submitting incomplete sections or applications

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Programmatic Screening

Applications may be programmatically withdrawn for the following reasons:

• Inclusion of cost-effectiveness analysis (CEA)
• Inclusion of development and dissemination of clinical practice

guidelines (CPG)

• Not responsive to the program-specific PFA

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Merit Review Process

pcori.org/content/merit-review-process

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Application Review

Applications are reviewed against six criteria:

1. Potential for the study to fill critical gaps in evidence 2. Potential for study findings to be adopted into clinical practice and improve delivery

• f care

3. Scientific merit (research design, analysis, data linkages, and outcomes) 4. Investigator(s) and environment 5. Patient-centeredness 6. Patient and stakeholder engagement ▪ Each application is reviewed by three scientists, one patient, and

• ne other stakeholder.

▪ PCORI’s Board of Governors makes funding decisions based

• n merit review and staff

recommendations.

Administrative Requirements Rhonda Stewart

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Preparing your Application for Submission

Getting Prepared

• Re-read the funding announcement for which you are applying:

https://www.pcori.org/funding-opportunities/announcement/limited-pcori- funding-announcement-partnerships-conduct-cycle-1-2019

• Review the PCORI Research Plan Template

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Research Plan Template

• Research Strategy
• Research Team and Environment
• Dissemination and Implementation Potential
• Protection of Human Subjects
• Consortium Contractual Arrangements
• References Cited
• Appendix

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Research Template – Page Limits

• Research Strategy – 15 pages
• Research Team and Environment – 2 pages
• Dissemination and Implementation Potential – 1 page
• Protection of Human Subjects – 5 pages
• Consortium Contractual Arrangements – 10 pages
• References Cited – 10 pages
• Appendix (Optional) – 10 pages

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Research Strategy

• Use the Research Plan Template as your guide
• Specific Aims
• Background
• Significance
• Study Design or Approach
• Study Population
• Recruitment Plan
• PLEASE provide all information requested, as outlined in the template

Page Limit

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PCORI Online: Application

• PI and Contact Information
• Project Information
• Key Personnel
• Templates and Uploads
• Save and Review

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Submitting an Application

• Start Early!
• Download the PFA-specific Research Plan Template, found on the Funding

Opportunities page on the PCORI website.

• Go into PCORI online, use Chrome or Safari browsers to access the system.
• DUE DATE FOR APPLICATION: July 25, 2019 – BY 5:00 P

.M. (ET)

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Submitting an Application – Cont’d

• Complete the required fields and upload the required documents:
• Research Plan Template – Note Page limits as outlined in the Template
• People and Places Template
• Leadership Plan Template – (only required if proposed project is dual-PI)
• Methodology Standards Checklist
• Milestone Template
• Budget Template
• Letters of Support

DUE DATE FOR APPLICATION: July 25, 2019 – BY 5:00 P .M. (ET)

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People and Places Template: Biosketch

• You may use the NIH biosketch OR PCORI’s format, which is provided in the

template

• Biosketches are required for ALL key personnel
• List all partners within the Key Personnel section
• Patient/Stakeholder Biosketch

Page Limit

5

Per person

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People and Places Template: Project/Performance Site(s)

• Demonstrate that the proposed facilities have the appropriate resources required

to conduct the project to plan, within budget, and on time.

• Provide a description of the facilities that will be used during the project,

including capacity, capability, characteristics, proximity, and availability to the project. Page Limit

15

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Budget Templates

• Three budget sections must be submitted as part of the online application

process:

Detailed Budget Budget Summary Budget Justification NOTE:

A detailed budget is needed for each year of the

• project. Complete each budget section for the

prime applicant and any/each subcontractor.

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Detailed Budget

• Personnel
• Consultant
• Equipment
• Supplies
• Travel
• Subcontract
• Engagement
• Other Expenses
• Consortium/Contractual Direct Costs
• Consortium/Contractual Indirect Costs
• Prime Indirect Costs

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Budget and Period Limitations

• Funds and Budget
• Direct Costs: Up to $2 million over the life of the project
• Indirect Costs: up to 40%
• Institutional base salary up to $200,000
• Indirect costs are capped on subcontracts/sub-awards
• The limit for Scientific Travel is $10,000 over the duration of the project. There is

no cap on Programmatic Travel

• Period of Performance: 3 years

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Budget Justification

• Provide a narrative that fully supports and explains the basis for the information

found in the Detailed Budget

• Provide sufficient detail to understand the basis for costs, the reason that the

costs are necessary, and an explanation for major cost variances

• Provide justification as to why the costs are reasonable for the work to be

performed

• Provide a breakdown of costs proposed for each consortia or contractor
• Must specify any other sources of funding that are anticipated to support the

proposed research project

• Provide quotes, indirect cost rate letter or agreement, and fringe benefit

policy

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Letters of Support

• All letters of support should be addressed to the PI and institution to demonstrate

the commitment of key personnel and supporting organizations to your proposed project.

• Letters of support should clearly reflect the substantive involvement and material

contribution to be provided by the signatory parties, and are meant to substantiate the commitment of collaboration of all forms.

• Letters of support should be organized in the following manner:
• Letters of Organizational Support
• Letters of Collaboration
• Letters confirming access to patient populations, data sets, and additional

resources

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Common Application Errors

• Using the wrong browser, access PCORI Online via Chrome or Safari browsers
• Not entering information into all required fields in the system
• Not clicking the ‘Save’ button
• Having multiple people working on the application at the same time
• Having the incorrect file extension, PDF and Excel files where applicable
• Not choosing the correct document type from the drop-down menu
• AO is unable to view the application

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Tips for Success

• Adhere to the PFA and Application Guidelines
• Talk to a Program Officer if you have questions
• Start and submit early
• Download PCORI Application Guidelines
• Ensure that all team members can see the application in the system
• Inform your AO of your intent to submit
• Submit the completed application before the due date or on it by 5:00 PM ET

Data Management and Data- Sharing

Jason Gerson, PhD

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PCORI’s Policy for Data Management and Data Sharing

• Approved by PCORI’s Board of Governors in September 2018
• Articulates expectations for data management and data sharing to

Awardees and applicants

• Provides funding to support Awardees’ time/effort to prepare data
• Specifies data and data documentation to be shared
• Specifies when data to be made available for third-party requests
• Describes third-party data request and review process

Submit questions to: OpenScience@pcori.org

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Data Deposition: Requirements for Research Awardees

Targeted and Pragmatic Clinical Studies Funding Announcements

• Deposit full data

package (or required data elements, as applicable) in a PCORI-designated repository PCORnet Funding Announcements

• Deposit applicable

data elements, such as the full protocol, analytic code used to query PCORnet data, and aggregate level datasets in a PCORI- designated repository Broad Funding Announcements

• Maintain full data

package for 7 years

• PCORI may notify

Awardee of its intent to provide funds for the deposition of the full data package in a PCORI-designated repository

Resources Kim Marschhauser, PhD

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Additional Application Resources

Refer to the funding opportunities page in our Funding Center (http://www.pcori.org/funding/opportunities) for the following resources:

• PFA and Application Guidelines
• PCORI Online User Manuals
• General Applicant FAQs: http://bit.ly/applicant_faqs
• PCORI Online: https://pcori.force.com/engagement/
• Research Methodology: http://www.pcori.org/node/4020

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Engagement Resources

• Engagement in Research website page http://www.pcori.org/funding-
• pportunities/what-we-mean-engagement
• ​Engagement Resources https://www.pcori.org/about-us/our-

programs/engagement/engagement-resources

• Updated Engagement Plan https://www.pcori.org/blog/putting-pcoris-updated-

engagement-plan-template-work-research

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Submission and Key Dates

What When LOI Deadline May 13th, 2019 by 5:00 PM ET Application Deadline July 25th, 2019 by 5:00PM ET Merit Review Date September 2019 Awards Announced November 2019 Earliest Start Date March 2020

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Questions and Answers

Contact Us:

• Schedule a call at http://www.pcori.org/content/research-inquiry
• Call 202-627-1884 (programmatic inquiries)
• Email us at sciencequestions@pcori.org
• Call 202-627-1885 (administrative and technical inquiries)
• Email us at pfa@pcori.org

Submit Questions via the chat function in GoToWebinar Ask a question via phone (press *7)

Thank You

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www.pcori.org @pcori /PCORInstitute PCORI /pcori

Contact Information

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Population of Interest Older Adults

PCORI HAS AWARDED

$195

MILLION

TO FUND52

COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH STUDIES AND METHODS PROJECTS RELATED TO DEMENTIA IN OLDER ADULTS

AS OF MAY 2018

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Cardiovascular Disease Cancer Dementia and Cognitive Impairment Diabetes Kidney Disease Mental and Behavioral Multiple Chronic Comorbid Conditions Allergies Digestive Diseases Arthritis Infectious Diseases Endocrine System Disorders Functional Limitations Liver Disease Addressing Disparities Multiple Sclerosis Ear, Nose and Throat Disorders

55 Neurological Disorders Pain Perinatal Health Precision Medicine Respiratory Diseases Trauma Skin Diseases Shared Decision Making Telehealth Transitional Care Rare Diseases Obesity Musculoskeletal Disorders Nutritional and Metabolic Disorders

Older Adults Children Low Socioeconomic Status Racial/Ethnic Minorities Urban Rural Women

Cardiovascular Disease Cancer Dementia and Cognitive Impairment Diabetes Kidney Disease Mental and Behavioral Health Multiple Chronic Comorbid Conditions Allergies Digestive Diseases Arthritis Infectious Diseases Endocrine System Disorders Musculoskeletal Disorders Addressing Disparities Multiple Sclerosis Ear, Nose and Throat Liver Disease Neurological Disorders Pain Obesity Nutritional and Metabolic Disorders Perinatal Health Functional Limitations

Respiratory Diseases Trauma Skin Diseases Shared Decision Making Telehealth Transitional Care Rare Diseases Low Socioeconomic Status Rural Children Urban Women Older Adults Racial/Ethnic Minorities Precision Medicine

Atlantic Blue RGB: 15, 24, 102 Homepage Blue RGB: 38, 125, 158 Stormy Blue RGB: 19, 66, 83 Purple RGB: 127, 42, 110 Orange RGB: 230, 85, 44 Darker Blue RGB: 51, 150, 187 Vibrant Green RGB: 122, 191, 53 Gray RGB: 64, 64, 64 Yellow RGB: 248, 208, 72 Lime RGB: 65, 135, 11 Lighter Blue RGB: 175, 210, 223 Vibrant Blue RGB: 8, 176, 255 Berry RGB: 222, 61, 91 Included in Theme Colors Not included in Theme Colors, but OK to Use

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Here are some editable icons. This means that you can:

• Resize them without losing quality.
• Change fill color and opacity.
• Change line color, width and style.

Examples: Other icons may be found by going to the “Insert” tab and clicking on “Icons.”