Partnerships To Conduct Research (PaCR) within PCORnet: Applicant - - PowerPoint PPT Presentation

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

Maryan Zirkle, MD, MS, MA Senior Program Officer, Research Infrastructure Mekia Winder, MPH Administrator, Contracts Operations Nora McGhee, PhD Senior Merit Review Officer, Office of the Chief Science Officer

August 23, 2017

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Agenda

Submitting Questions:

Submit questions via the chat function in GoToWebinar.

Programmatic Overview Letters of Intent and Full Application Merit Review Administrative Requirements Resources/FAQs

• Objective

– This 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:

– Generate CER evidence relevant to specific conditions, treatments, and patient communities or more generally to clinical care for broader populations; – Support PCORnet sustainability by attracting collaboration and support from non-PCORI funders in CER research; – Develop data linkages between patient data and data from electronic health records, claims data and/or disease-specific registries.

PaCR: Overview

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• PCORI seeks to fund 3–5 high-quality clinical studies to answer important

patient- and stakeholder-prioritized comparative clinical effectiveness research (CER) questions that remain unanswered due to insufficient or inconclusive evidence. – PCORI is soliciting applications only from PPRNs currently funded under the Phase II PCORnet award. – Each PPRN is eligible to submit one LOI.

PaCR: Eligibility and Budget

Project Budget: Up to $15 million in direct costs to fund up to five projects; up to $5 million per project Project period: Maximum of 3 years Project Budget: Up to $15 million in direct costs to fund up to five projects; up to $5 million per project Project period: Maximum of 3 years

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• Partner Funding:

– Applicants will be required to secure partner funding (which may include in- kind resources) and support from industry and/or organizational collaborators prior to submitting the full application.

• Application will need to provide strong, convincing letters of collaboration from

collaborating funders.

• Data Linkages:

– Linkages between patient data and EHR/clinical data (CDRNs), claims data and/or with data from a disease-specific registry.

• Stakeholder-driven Priority Topic:

– Applications must address stakeholder-driven priority topic areas with a CER question related to a rare or common condition.

PaCR: Specific Requirements

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• PCORnet Infrastructure:

– Coordinating Center – Collaborative Research Groups (CRGs) – Streamlined IRBs, contracting, engagement, and consenting processes – PCORnet’s Common Data Model (CDM), where applicable – The Commons

• Comprehensive and Complete Data:

– Specific PPRN and other PPRNs – CDRNs – Data sources other than PCORnet – Registries – Health Plans – CMS

PaCR: Leveraging Existing Resources

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Letters of Intent (LOI) Letters of Intent (LOI)

PCORI is offering a system-based webinar for Cycle 2 2017 Partnerships to Conduct Research within PCORnet (PaCR) applicants submitting a Letter of Intent (LOI) through the new PCORI Online.

• This webinar will cover the following processes:
• Navigate PCORI Online
• Update an LOI in Progress
• Submit and LOI for PCORI Review

Monday, August 28, 2017 - 01:00 pm to 02:00 pm ET Register at: http://www.pcori.org/events/2017/partnerships-conduct-research-within- pcornet-pacr-%E2%80%93-loi-submission-system-webinar

(PaCR) – LOI Submission System Webinar

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• The Patient-Centered Outcomes Research Institute (PCORI) will screen Letters of

Intent (LOIs) for responsiveness to this PCORI Funding Announcement (PFA) and for fit to program goals – PCORI will invite applicants whose LOIs are most responsive to this PFA and to the criteria to submit a full application – Only those applicants selected may submit full applications

Due Date for LOI Submission: September 6, 2017 by 5 p.m. ET

Letters of Intent (LOIs)

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• LOI Review will be based on the following criteria:

– Importance of the research question to current clinical decision making, as evidenced by critical gaps identified by clinical guidelines developers or recent relevant systematic reviews – Study scope sufficient to have a significant impact on patient outcomes or healthcare practices – Clarity and credibility of applicants’ responses to the LOI questions—including the rationale for the estimated sample size (i.e., citing published estimates, including effect sizes, standard deviations, and the need for rigorous comparative analysis of important subgroups); proposed partnerships and the anticipated level of partner-funding supporting the project; plans for advancing data integration; and use and enhancement of existing PCORnet infrastructure resources

• Adherence to the administrative and formatting requirements listed in the

Application Guidelines—THREE PAGE LIMIT FOR THE LOI Notification of denial or approval to submit a full application will occur no later than September 26, 2017.

Letters of Intent (LOIs)

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Full Applications Full Applications

• 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 CDRNs, PPRNs, Health Plans Research Networks (HPRNs), their affiliated study performance sites, and PCORnet Collaborative Research Groups (CRGs) that will be collaborating on the project. Also, describe how you will minimize risk to the proposed study throughout the performance period after PCORnet Phase II infrastructure funding (to participating CDRNs, PPRNs, HPRNs, and/or CRGs) ends. – 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 across proposed study sites, research consortia, and/or other collaborating organizations and whether you will use any dedicated data-coordinating functions or facilities. When feasible and relevant, the PCORnet Coordinating Center should meet data coordination needs.

Development of the Research Strategy

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• 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

• f 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

Research Team and Environment

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Patient-Centeredness

• Research questions and outcomes reflect what is important to

patients and caregivers and consider patient preferences Patient Engagement

• Project includes active engagement among scientists, patients and

stakeholders

• Projects includes community, patient and caregiver involvement

Patient-Centeredness and Patient Engagement

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• 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

Dissemination and Implementation Potential

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• 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 organizations 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 or her subcontracts accordingly. – PCORI does not require signed subcontract agreements at the time of application submission

Consortium Contractual Agreements

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• Can the linkage requirements be fulfilled with linkage to Health Plan data?

– Yes

• Each of the 5 projects can get up to $5M, but there is only $15M available. How

does that work? – Up to 5 projects can be awarded, for a total of $15M in direct costs, and up to $5M each. So, if there are proposals approved for less than $5M, there may be more than 3 projects (but no more than 5).

• Are you considering the contribution from other funders as part of the $5M?

– No. The amounts listed ($5M) are PCORI-funding only.

• Can an institution within a PPRN that is NOT the Prime, be the Prime for this

Award? – Yes

• What is the format for submission of the LOI and the full application?

– The format is the same as other PCORI PFAs and can be found in the Application Guidelines for this PFA. Any changes would be related to providing detailed information on the specific content areas of the PFA.

PaCR: FAQs

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Merit Review Merit Review

• Multistep Process

– Full applications are screened by PCORI staff for responsiveness to PFA and consistency with LOI – Preliminary (online) review by external panel – In-Person review (external panel) – Post-Panel review (PCORI program staff) – Funding decisions approved by external Board of Governors

• Address all Merit Review criteria within your application:

– PCORI’s external reviewers evaluate and score each of the six merit review criteria for help in determining their overall score (see Merit Review section in PFA).

Merit Review

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• Invited applications are reviewed by an external panel comprised of 3 reviewer

types to bring diverse perspectives

• Each application is reviewed by 5 individuals -- 3 scientists, 1 patient, and 1 other

stakeholder

Patient-Centered Merit Review Process

Patients Scientists/Clinician Researchers Other Stakeholders

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Merit Review Criteria

Crosswalk of PCORI Merit Review Criteria with NIH Criteria

SIGNIFICANCE

• 1. Potential for the study to fill critical gaps in

evidence

• 2. Potential for the study findings to be adopted

into clinical practice and improve delivery of care

APPROACH

• 3. Scientific merit (research design, analysis, and
• utcomes)
• 4. Investigator(s) and environment

PCORI-only Merit Review Criteria

PATIENT-CENTEREDNESS/ ENGAGEMENT

• 5. Patient-centeredness
• 6. Patient and stakeholder engagement

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Administrative Requirements Administrative Requirements

• Getting Prepared

– Re-read the funding announcement for which you are applying: http://www.pcori.org/funding-opportunities/announcement/limited-pcori- funding-announcement-partnerships-conduct-research – Review the PCORI Research Plan Template

Preparing your Application for Submission

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►

Research Strategy

►

Research Team and Environment

►

Dissemination and Implementation Potential

►

Protection of Human Subjects

►

Consortium Contractual Arrangements

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References Cited

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Appendix

Research Plan Template

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Page Limit

15 Research Strategy

• Maximum 15 pages in length
• Use the Research Plan Template as your guide

– Specific Aims – Background – Significance – Study Design or Approach – Patient Population

• Recruitment Plan
• PLEASE provide all the information requested, as outlined in the template.

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

Research Template – Page limits

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PCORI Online: Application

► PI and Contact Information ► Project Information ► Key Personnel ► Milestones ► Templates and Uploads ► Save and Review

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

Opportunities page on PCORI website.

• Go into PCORI Online, use Chrome or Safari browsers to access the system.
• DUE DATE FOR APPLICATION: December 6, 2017–BY 5:00 P.M. (ET)

Submitting an Application

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• Complete the required fields and upload the required documents:

– Research Plan Template – Note Page limits as outlined in the Template – People and Places Template – Budget Template – Letters of Support DUE DATE FOR APPLICATION: December 6, 2017–BY 5:00 P.M. (ET)

Submitting an Application

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• 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

People and Places Template: Biosketch

Page Limit

5

Per person

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• 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.

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

Professional Profile/Biosketch

Page Limit

15

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

Budget Templates

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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Budget and Period Limitations

Funds & Budget

• Direct costs: up to $5 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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• Personnel
• Consultant
• Equipment
• Supplies
• Travel
• Subcontract
• Engagement
• Other Expenses
• Consortium/Contractual Direct Costs
• Consortium/Contractual Indirect Costs
• Prime Indirect Costs

Detailed Budget

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• 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, and fringe benefit policy

Budget Justification

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

demonstrate the commitment of key personnel and supporting

• rganizations 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

Letters of Support

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• 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, only PDF files can be uploaded
• Not choosing the correct document type from the drop-down

menu

• AO is unable to view the application

Common Application Errors

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• Adhere to the PFA and Application Guidelines
• Talk to a Program Officer if you have questions
• Start and submit early
• Download PCORI’s Online User Manual for Submitting an Online

Application

• 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

Tips for Success

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Resources 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
• Applicant Training:

http://encore.meetingbridge.com/MB005418/170118_1000i/

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

Additional Application Resources

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Submission and Key Dates

What When

Applicant Town Hall August 23, 2017 at 12:00 pm ET LOI Submission System Webinar August 28, 2017 at 1:00 pm ET LOI Deadline September 6, 2017 by 5:00 pm ET LOI Screen Notification September 26, 2017 Application Deadline December 6, 2017 by 5:00pm ET Merit Review Dates January 2018 Awards Announced March 2018 Earliest Start Date May 2018

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Questions and Answers

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

Contact Us:

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

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Thank You

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