The PCORI Application Process

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The PCORI Application Process

James Hulbert Pre-‐Award Manager February 19, 2015

Welcome!

James Hulbert

Pre-Award Manager

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Session Objectives

• List and deﬁne each sec>on of the PCORI

applica>on

• State the purpose of each template in the

PCORI Applica>on Process

• Submit an online applica>on without errors

• Introduce the review process

• Discuss the PCORI informa>on request process

• Describe where to ﬁnd help

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•  Any private sector research organiza>on

•  Any public sector research organiza>on

•  Foreign Organiza>ons

•  Nondomes>c Components of Organiza>ons based in US

Application Requirements: Who Can Apply?

Non-Profit Organizations

For Profit Organizations

NOTE PI must be an employee of the prime applicant _{institution. Individuals are not eligible to submit}

research applications to PCORI.

Universities/ Colleges Hospitals or Healthcare Systems Local, State, or Federal Government Laboratories

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What Does PCORI Look For in Applications?

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The PCORI Funding Center

7 Contains details about:

•  PCORI’s Applica>on Process

•  Key dates and deadlines

•  How to access PCORI’s Online Applica>on System and build an applica>on

•  PCORI’s applica>on guidelines, checklists, and templates

•  Access to training webinars

NOTE

Documentation of Assumptions has been renamed Justification of Assumptions and moved to the Application Guidelines.

PCORI’s Online Application System

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PCORI’s Online Application Process

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What is the Letter of Intent (LOI)?

•  An LOI is required in order to submit an applica>on

•  LOIs are NOT scored

•  The LOI includes:

–  Organiza>onal Informa>on –  Informa>on about Key

Personnel

–  Technical Overview

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Responsiveness Review

•  LeWers of Intent are reviewed based on criteria detailed in each PFA

•  Addi>onal screening for

– Compara>ve eﬀec>veness research – Inclusion of cost-‐eﬀec>veness analysis – Administra>ve Guidelines

•  Only responsive LOIs will be invited to submit a full applica>on

•  Based on the topic areas of the received LOIs, reviewer recruitment will begin

11 Comparative Effectiveness Research Inclusion of Cost-Effectiveness Analysis Programmatic Fit

Fall Cycle LOIs

LOIS received: 828 LOIS accepted: 290 Rejected: 538

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Letters of Intent

35% 65% LOIs Received Accepted Rejected 96% 4%

Reason for RejecHon

Non-‐responsive programma>cally Administra>vely non-‐compliant LOIS received: 828 LOIS accepted: 290 Rejected: 538 NOTE:

LOI Review and Approval Process

Only one application can be submitted per PFA per cycle. Invitations to submit full applications will be sent

Applicants will be notified if they are / are not approved to submit full application

LOI Screened

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Greater than Time/Budget Request: Budget

Limitations

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As of 2015, PCORI is

no longer accep>ng

Greater Than

Budget and Time

Requests for Broad

PFAs

NOTE: Do not expect to receive either a cost or a no-cost extension.

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PCORI Online: Application

17 •  PI and Contact Information

•  Project Information •  Key Personnel •  Milestones

•  Templates and Uploads •  Save and Review

LOI to Application

You were invited to submit a full applica>on based

on the informa>on provided in the LOI, changes

a]er the LOI require PCORI approval.

Show stoppers include:

Changes to

the PI

Changes to

the

Ins>tu>on

Changes to

the Study

Design

Changes in

Engagement

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19 Public Abstract

Project

Information

Technical Abstract Project Narratives NOTE

Research Strategy instructions in the Research Template and Application Guidelines have been updated.

PCORI Monitors Projects Against

Milestones & Deliverables

Deliverables:

Measurable and veriﬁable

outcomes or objects that a

project team must create and

deliver according to the

contract terms

Milestones:

Signiﬁcant events or accomplishments

within the project; may have

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Milestone & Deliverable Schedule

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How does it differ from the project plan and timeline?

What information should be included? What is the purpose?

Where should milestones be entered?

NOTE:

Make it clear that you can achieve your milestones

and submit your deliverables in the approved timeframe and

within budget. Refer to guidelines for

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Resubmission Letter

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Resubmission Letter

•  Star>ng this spring there is a

new resubmission policy – Resubmission may be requested by PCORI •  Review and address the

previous reviewers’ comments thoroughly

NOTE Information regarding resubmissions has been

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Research Plan Template

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Research Plan Template: Overview

►  Demonstrate how the team you have will complete the project

►  Describe your research approach and methods clearly

►  Indicate how your project adheres to the Methodology Standards

►  Ensure your research questions are comparative

►  Use clear, concise language (avoid jargon)

►  Review PCORI’s Merit Review criteria in advance Helpful Hints

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►  Research Strategy

►  Dissemination & Implementation Potential ►  Replication & Reproducibility of Research

and Data Sharing

►  Protection of Human Subjects

►  Consortium Contractual Arrangements ►  References Cited

►  Appendix

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Research Plan Template—Research Strategy

A. Background

B. Signiﬁcance

C. Study Design or Approach

D. Project Milestones and Timeline

E. Pa>ent Popula>on

F. Research Team and Environment

G. Engagement Plan

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Page Limit

20

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Dissemination & Implementation

A.  Describe the poten>al for

dissemina>ng and

implemen>ng the results of this research in other seangs. B.  Describe possible barriers to

dissemina>ng and

implemen>ng the results of this research in other seangs. C.  Describe how you will make

study results available to study par>cipants a]er you complete your analyses.

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Page Limit

2 Replication & Reproducibility of Research and

Data Sharing

A.  Describe the ability to reproduce poten>ally important ﬁndings from this research in other data sets and popula>ons.

B.  Describe how you will make a complete, cleaned, de-‐iden>fied copy of the final data set used in conduc>ng the final analyses available within 90 days of the end of the final year of funding, or your data-‐sharing plan, including the method by which you will make this data set available, if requested.

C.  Propose a budget to cover costs of your data-‐ sharing plan, if requested.

Page Limit

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ProtecHon of Human

Subjects

•  Describe the protec>on of human subjects who will be involved in your research

ConsorHum Contractual

Arrangements

•  Describe the proposed research projects that will be performed by

subcontracted

organiza>ons; explain the strengths that these partners bring to the overall project 33 Page Limit

5

(each)

References Cited

Following scholarly cita>on prac>ce, list

the source material cited in this

Research Plan

Page Limit

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Appendix

•  PCORI applica>ons may include an

appendix for addi>onal materials the inves>gators think may be useful

–  Survey instruments

–  Papers and publica>ons from

members of the research team; however, reviewers will not be required to include the

appendices in the review and assessment of the project

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Page Limit

10

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People and Places Template

Biosketch

•  You may use the NIH biosketch or PCORI’s format

•  Biosketches are required for all key personnel

•  List all partners within the Key Personnel sec>on

•  Pa>ent/Stakeholder Biosketch Page Limit

5

Per person

NOTE: Build an appropriate and well-justified research _{team who can provide assurance the project will be}

successful.

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People and Places Template

Project/Performance Site

•  Demonstrate that the proposed facili>es have the appropriate

resources required to conduct the project to plan, within budget, and on >me

•  Provide a descrip>on of the facili>es that will be used during

the project, including capacity, capability, characteris>cs, proximity, and availability to the project

Page Limit

15

Professional

Profile/Biosketch Patient/Stakeholder Partner Biosketch

Project/Performance Site(s) and

Resources

NOTE: Follow PCORI’s required naming conventions

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Budget

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Budget

• Be reasonable

• Be detailed

• Jus>fy your costs

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Detailed Budget

•  Personnel •  Travel •  Supply •  Equipment •  Consultant •  Consor>um/Contractor •  Other Direct •  Total Direct •  Indirect 43 NOTES

A detailed budget is needed from each collaborator. Inpatient and Outpatient Costs within the Detailed Budget for Each Year of Project Period section has been removed.

Budget Summary

•  Personnel •  Consultant Costs •  Equipment •  Supplies •  Travel •  Other Expenses •  Consor>um/Contractual Direct Costs •  Consor>um/Contractual Indirect Costs

•  Prime Indirect Costs

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40%

Indirect Costs

•  Indirect costs are calculated at up to 40% of the allowable direct costs

•  If you do not have an audited indirect cost, you may request up to 10% indirect costs

–  Must be noted in the Budget Jus>ﬁca>on

•  Foreign organiza>ons may request up to 10% indirect costs

•  You may only assess indirect costs on the ﬁrst $25,000 of all consor>um/subcontractor costs combined

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NOTE: New Requirement: the use of 10% indirect cost rate

must be noted in the Budget Jus>ﬁca>on.

Budget Justification

•  Narra>ve that fully supports and explains the basis for the informa>on in the Budget Detail

–  Provide suﬃcient detail to understand the basis for costs, the reason that the costs are necessary, and an explana>on for major cost variances –  Use the budget template to tell PCORI why the

costs are reasonable for the work to be performed

•  Breakdown of costs proposed for each consor>a or contractor

•  Must specify any other sources of funding that are an>cipated to support the proposed research project

•  Provide quotes, indirect cost rate leWer, fringe beneﬁt policy

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Budget Templates: Overview

Three budget secHons must be submiWed as part of the online applica>on process:

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Detailed Budget Budget Summary _{Justification}Budget

NOTE: A detailed budget is needed for each year of the _{program. Complete each budget section for the}

prime applicant and any/each subcontractor.

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Letters of Support

49 Demonstrate the commitment of key personnel and/or your organization’s leadership to the research project

•  Address letters to the PI

•  Not required for research assistants or others who are not contributing in a substantive, measurable way to the project

•  Letters from your leadership and/or organizations

supporting dissemination and implementation of research findings are strongly encouraged

•  Follow instructions, a Letters of Support table has been added

Purpose

Helpful Hints

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Administrative Requirements

• Include but are not limited

to:

–

 

Required Templates

–

 

Length/Limit

–

 

File Formats

–

 

File Naming Conven>ons

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NOTE: Applications that do not meet the formatting criteria or documentation requirements may be

eliminated from consideration.

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Tips for Success

•  Download

PCORI’s Online User Manual for Submiang an Online Applica>on

•  Adhere to the PFA and Applica>on Guidelines for the funding cycle

you are applying to

•  Ensure that all team members can see the applica>on in the

system (check during the LOI stage)

•  Submit the completed applica>on before the due date or on

it by 5:00 PM ET

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NOTE:

PCORI’s Online Application is NOT like Grants.gov. Familiarize yourself with the system and start the application process early.

But Wait….

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Help Desk at Close of Cycle

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PCORI Help Center

Program: 202-‐627-‐1884; scienceques>[email protected]

Help Desk (8:30-‐5:00 EST): 202-‐627-‐1885; [email protected]

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ApplicaHon Deadline Final Decision

~5 Months

What Happens Next?

PCORI’s Merit Review Process

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Programmatic Screening

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►  Study deviates from approved LOI

►  Study includes cost-effectiveness analysis

►  Study is not responsive to PFA and/or does NOT address the PFA’s “Research Areas of Interest”

►  Study is not comparative

Missing the Mark PFA Responsiveness PCORI Mission Advance Through to Merit Review

Administrative Screening

Applicants must follow administra>ve requirements

set in PCORI’s Applica>on Guidelines.

►  Exceeding page limits, budget, or time limitations

►  Not using PCORI’s required templates

►  Submitting incomplete sections or applications

Missing the Mark

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Fall 2014 Cycle Applications

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PCORI Information Request (PIR)

•  A formal instrument for PCORI to request

addi>onal informa>on or clarify issues/concerns raised during the review process.

•  The PIR leWer may ask applicants to address both

administra>ve and programma>c issues.

•  Applicant responses to the PIR request may be

used by PCORI staﬀ to help develop a funding slate.

•  Applicants typically have 1-‐2 weeks to respond

to the request leWer.

•  Receipt of a PIR leWer should not be construed as an intent to fund by PCORI.

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Summary

•  Sec>ons of the PCORI applica>on

•  Purpose of each template in the PCORI Applica>on Process

•  Where to ﬁnd help

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Thank You!

James Hulbert Pre-‐Award Manager