PCORI Awards: From Announcement to Closeout Gali Gabriento, MSc - - PowerPoint PPT Presentation

PCORI Awards: From Announcement to Closeout

Gali Gabriento, MSc Lauren Massey

Administrators, Contracts Management

November 2, 2018

#PCORI2018

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Welcome

Lauren Massey

Administrator, Program Support and Information Management

Gali Gabriento, MSc

Administrator, Program Support and Information Management

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In This Session

• PCORI Funding Announcements
• Application Process
• Award Announcement and

Contract Activation

• Active Portfolio Management
• Contract Closeout

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PCORI Funding Announcements (PFA)

Contains details about:

NOTE Be sure to download templates for the cycle you are submitting to.

˃ PCORI Application Process ˃ Key Dates and Deadlines ˃ Accessing PCORI Online and Application ˃ Application Guidelines, Checklists and Templates ˃ Training and Webinars

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Who Can Apply?

• Any private sector research organization
• Any public sector research organization
• Foreign Organizations
• Nondomestic Components of Organizations based in the US

Non-Profit Organizations

For Profit Organizations Universities/ Colleges Hospitals or Healthcare Systems Laboratories

Local, State,

• r

Federal Government

NOTE

PI must be an employee of the prime applicant

• institution. Individuals are not eligible to submit

research applications to PCORI.

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What Does PCORI Look For?

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Let’s Chat

• T

alk to a Program Officer

• Bounce ideas
• Determine if there is a “fit”
• Can the study be improved?
• Call early…don’t wait until the deadline
• Program Officer: 202-627-1884
• Complete online Inquiry Form

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PCORI’s Online Application Process

STEP 1 Submit a Letter of Intent STEP 2 Begin Full Application Process STEP 3 Submit for Authorization and to PCORI

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What is the Letter of Intent (LOI)?

• An LOI is required to submit an application
• LOIs are NOT scored
• The LOI includes:
• Organizational Information
• Key Personnel
• T

echnical Overview

NOTE

LOI is comprised of two components:

• nline questions and an uploaded file.

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LOI Review and Approval Process

LOI Screened LOI Submitted

NOTE Only one LOI can be submitted per PFA per cycle. Invitations to submit full applications will be sent after the submission deadline, as detailed in the PFA.

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Tips for Submitting A Responsive LOI

11 https://www.pcori.org/video/tips-submitting-responsive-loi

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LOI Acceptance/Rejection – FY 2018 (YTD)

LOIs received: 578 LOIs accepted: 303 LOIs rejected: 275

48% 52%

Rejected Accepted LOIs Received Reason for Rejection 21.4% 78.5

Administratively Rejected Programmatically Rejected

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LOI to Application

You were invited to submit a full application based

• n the information provided in the LOI, changes

after the LOI require PCORI approval.

Show stoppers include:

Changes to the PI Changes to the Institution Changes to the Study Design Changes to Research Question Changes to Specific Aim Changes to Comparators

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Responsive LOI Strong Application Funded Project

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PCORI’s Online Application Process

STEP 1 Submit a Letter of Intent STEP 2 Begin Full Application Process STEP 3 Submit for Authorization and to PCORI

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Planning for the Submission

• Create calendar with key dates
• Build time buffers
• Download the full application package
• Use provided templates and checklists
• Communicate often

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PCORI Online – Application Tabs

Application Tabs

Contact information (LOI)

Add basic contact information for the Organization/Institution, including the PI, AO, and any Designees Contact Information

Budget

Provide details related to the budget of the project Budget

Project Narratives

Provide more detail regarding your proposed research, including abstracts, narratives, and goals Project Narratives

Milestones

List concrete, specific events or accomplishments that will be documented as contractual tasks of your project. Milestones

Templates and Uploads

Download any applicable templates, and upload attachments to include with the Application Templates & Uploads

Project Information (LOI)

Provide relevant project information, including the focus disease or condition, projected costs, target populations, and analytic methods. Project Information

Project Personnel (LOI)

Add the names of Project Personnel who will make up the Awardee Project team. Project Personnel NOTE If funded, the public abstract will be posted on the PCORI website.

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PCORI Monitors Projects Against Milestones & Deliverables

Milestones:

Significant events or accomplishments within the project; may have deliverables associated with them

Deliverables:

Measurable and verifiable outcomes or

• bjects that a project team must create

and deliver according to the contract terms

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Milestone Schedule

Examples of milestones:

• When will you have IRB approval?
• When will enrollment begin?
• Key meetings
• 25% / 50% / 75% / 100% enrolled
• Completion of data analysis

Milestone- Deliverable ID Milestone - Deliverable Name Description Due Date A Effective Date Within first 6 months B1 Develop, finalize, and submit copy of study protocol in PCORIOnline Please refer to the PCORI Methodology Standards for required elements of the study protocol. Within first6 months B2 Submit IRB approvalin PCORI Online {Continuing approval submitted annually} First IRB approval should be within first 6-9months B3 Select and register project at appropriate site for the studydesign {Clinicaltrials.gov, RoPR,

• r other as approved by

PCORI before study start date) Submit Study Identification Number and the Primary Completion Date to PCORI. List PCORI as a collaborator so that PCORl's role as the funder (not sponsor} can be identified and tracked. Within first6 months B4 Submit updated Data Safety and Monitoring Plan to PCORI Please refer to the PCORI Policy on Data Safety and Monitoring Plans for PCORI- Funded Research here: https://www.pcori.org/sites/default/files/P CORI-Policy-Data-Safety-Monitoring- Plans.pdf Withinfirst6 months! blank blank

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Peer Review

The goal of peer review is to ensure that the primary research studies funded by PCORI are held to the highest standards of scientific integrity, methodological rigor, and relevance and usefulness to patients, caregivers, clinicians, and other healthcare stakeholders.

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Determining A Project Budget

Follow these three points to develop the proposed project budget:

• Be realistic

– Do you really need the maximum allowable budget? – Avoid the danger of wanting to stretch every penny

• Be detailed

– Breakout the costs by category – Include quotes / estimates

• Justify your costs

– Explain what funds will be used for – Tie the costs to the scope of work – Note any abnormal requests

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Allowable and Unallowable Costs

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Indirect Cost Rate

• Calculated at up to 40% of the allowable direct costs for prime and

subcontractors.

• If you do not have an audited rate, you may request up to 10%
• Must be noted in the budget justification
• Foreign organizations may request up to 10% indirect costs
• Y
• u may assess indirect costs on the first $25,000 of each subcontractor

40%

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Budget Justification

• Download appropriate template for the PFA and the Cycle
• Justify the costs for the prime applicant and each subcontracted organization for the

entire Research Project Budget and Peer-Review Budget for each budget category.

• Describe the specific role and tasks each research team member will perform and the

impact on the Project Plan.

• Provide a clear distinction between those who should be Key Personnel and those

who should be Other Personnel

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PCORI’s Online Application Process

STEP 1 Submit a Letter of Intent STEP 2 Begin Full Application Process STEP 3 Submit for Authorization and to PCORI

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Board of Governor's Announcement

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Award Announcement

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Final Review

Milestones and Project Plan

• Program will work with awardee to finalize milestones and

project plan Budget

• Contract Management will work with awardee to finalize

budget

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Issuance of a Contract

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You Have a Contract, Now What?

• Confirm your contract details!
• Effective start and end dates
• Project title
• Final budget
• Milestone schedule
• Negotiations
• Send an introductory e-mail upon contract execution.
• Conduct a kickoff call.
• Team introductions
• Manage expectations
• Let us know what’s new
• Staff changes
• Subcontractor changes
• Organization changes

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Getting Set Up to Receive Payment

• Establish vendor profile
• Complete a W9
• Address, EIN & DUNS confirmation
• Go online and establish your electronic

payment profile

• Currently: Bill.com system

NOTE The Awardee’s Financial Officer will need to have an account in PCORI Online and be linked to the award to submit and track their invoices in PCORI Online.

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Invoices

• Requirements
• Submitted at PCORI Portal
• No less than every 90 days
• No more frequently than monthly
• Receipts where applicable
• PCORI reviews project invoices to ensure the following:
• Charges are allowable, allocable, reasonable, and consistent
• Funds are spent in accordance with the approved budget
• CM/Finance/Programmatic reviews

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Active Portfolio Management

• Effective monitoring helps to ensure:
• Contract Compliance
• Consistency with the Project Work Plan
• Completion of Contract Milestones
• Adjustments as necessary during the Award
• Modifications
• Project success - deliverables completed on time

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Reporting

• Project Progress Reports (Interim and Special)
• Annual Conflict of Interest (COI) Reporting
• Final Reports
• Final Progress Report
• Final Research Report
• Notification of Publication Acceptance

*Please refer to PCORI’s Awardee Resources web page here: http://www.pcori.org/funding-opportunities/awardee-resources

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Desk Reviews and Site Visits

• Undertaken by CM to:
• Discuss performance improvement when necessary.
• Learn about the recipient’s process.
• Most site visits start with desk reviews.
• Site visits may be performed randomly or for cause.
• Desk reviews and site visits may be performed by:
• PCORI
• Authorized third-party
• Government Accountability Office (GAO)

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Period of Performance

• Milestones and deliverables ensure that the funded project is

completed on time

• Efficient project management strategies will place you ahead of the

curve

More Time

Just Ahead

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Possible Termination

• Termination may result from:
• Significant delays and/or deficiencies
• Patient/Subject recruitment
• Significant changes to study protocol without PCORI’s approval
• Not adhering to PCORI’s Methodology Standards
• Breach of contract
• Action taken before a termination:
• Active Portfolio Management
• Letter of Concern
• Remediation Plan
• Notice of Intent to Terminate

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Contract Closeout

The process PCORI uses to determine that all contract requirements have been satisfied, including milestones and deliverables.

• Programmatic closeout
• Conclusion of Research
• Project closeout
• Peer Review and Public Dissemination
• Financial closeout
• Final invoice

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Record Retention

Maintain Project Records As described in your contract

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Questions?

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Thank You

Gali Gabriento, MSc Lauren Massey

Administrators, Contracts Management