PCORI Awards: From Announcement to Closeout Gali Gabriento, MSc Lauren Massey Administrators, Contracts Management November 2, 2018 #PCORI2018
Welcome Lauren Massey Gali Gabriento, MSc Administrator, Administrator, Program Support and Information Program Support and Information Management Management 2 2
In This Session • PCORI Funding Announcements • Application Process • Award Announcement and Contract Activation • Active Portfolio Management • Contract Closeout 3 3
PCORI Funding Announcements (PFA) Contains details about: ˃ PCORI Application Process ˃ Key Dates and Deadlines ˃ Accessing PCORI Online and Application ˃ Application Guidelines, Checklists and Templates ˃ Training and Webinars Be sure to download templates for the NOTE cycle you are submitting to. 4
Who Can Apply? • Any private sector research organization Non-Profit For Profit Organizations Organizations • Any public sector research organization Hospitals or State, or Local, Universities/ Healthcare Laboratories Federal Colleges Systems Government • Foreign Organizations • Nondomestic Components of Organizations based in the US PI must be an employee of the prime applicant institution. Individuals are not eligible to submit NOTE research applications to PCORI. 5
What Does PCORI Look For? 6
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 7
PCORI’s Online Application Process STEP 1 STEP 2 STEP 3 Submit a Begin Full Submit for Letter of Application Authorization Intent Process and to PCORI 8
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 LOI is comprised of two components: NOTE online questions and an uploaded file . 9
LOI Review and Approval Process LOI Screened LOI Submitted Only one LOI can be submitted per PFA per cycle. Invitations to submit full applications will be sent after NOTE the submission deadline, as detailed in the PFA. 10
Tips for Submitting A Responsive LOI https://www.pcori.org/video/tips-submitting-responsive-loi 11 11
LOI Acceptance/Rejection – FY 2018 (YTD) LOIs received: 578 LOIs Received LOIs accepted: 303 LOIs rejected: 275 52% 48% Reason for Rejection 21.4% Administratively Rejected Programmatically Rejected 78.5 Rejected Accepted 12
LOI to Application You were invited to submit a full application based on the information provided in the LOI, changes after the LOI require PCORI approval. Show stoppers include: Changes to Changes to Changes to Changes Changes to Changes to the the Study Research to the PI Specific Aim Comparators Institution Design Question 13
Responsive LOI Strong Application Funded Project 14
PCORI’s Online Application Process STEP 1 STEP 2 STEP 3 Submit a Begin Full Submit for Letter of Application Authorization Intent Process and to PCORI 15
Planning for the Submission Create calendar with key dates • Build time buffers • Download the full application package • Use provided templates and checklists • Communicate often 16
PCORI Online – Application Tabs Application Tabs Contact information Add basic contact information for the Organization/Institution, including Contact Information the PI, AO, and any Designees (LOI) Budget Provide details related to the budget of the project Budget Provide more detail regarding your proposed research, including abstracts, Project Narratives Project Narratives narratives, and goals List concrete, specific events or accomplishments that will be documented Milestones Milestones as contractual tasks of your project. Download any applicable templates, and upload attachments to include Templates and Uploads Templates & Uploads with the Application Project Information Provide relevant project information, including the focus disease or Project Information (LOI) condition, projected costs, target populations, and analytic methods. Add the names of Project Personnel who will make up the Awardee Project Personnel (LOI) Project Personnel Project team. NOTE If funded, the public abstract will be posted on the PCORI website. 17
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 objects that a project team must create and deliver according to the contract terms 18
Milestone Schedule Milestone- Deliverable Milestone - Deliverable Examples of milestones: ID Name Description Due Date Within first 6 A Effective Date blank months • When will you have IRB approval? Develop, finalize, and Please refer to the PCORI Methodology Within first6 submit copy of study Standards for required elements of the B1 months protocol in PCORIOnline study protocol. • When will enrollment begin? Submit IRB approvalin First IRB approval PCORI Online • Key meetings B2 should be within blank {Continuing approval first 6-9months submitted annually} • 25% / 50% / 75% / 100% enrolled Select and register project at appropriate Submit Study Identification Number and the site for the studydesign Primary Completion Date to PCORI. List • Completion of data analysis Within first6 {Clinicaltrials.gov, RoPR, B3 PCORI as a collaborator so that PCORl's role months or other as approved by as the funder (not sponsor} can be identified PCORI before study start and tracked. date) Please refer to the PCORI Policy on Data Safety and Monitoring Plans for PCORI- Submit updated Data Funded Research here: Withinfirst6 Safety and Monitoring B4 https://www.pcori.org/sites/default/files/P months! Plan to PCORI CORI-Policy-Data-Safety-Monitoring- Plans.pdf 19
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. 20
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 21
Allowable and Unallowable Costs 22
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% 40% • Must be noted in the budget justification • Foreign organizations may request up to 10% indirect costs • Y ou may assess indirect costs on the first $25,000 of each subcontractor 23
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 24
PCORI’s Online Application Process STEP 1 STEP 2 STEP 3 Submit a Begin Full Submit for Letter of Application Authorization Intent Process and to PCORI 25
Board of Governor's Announcement 26
Award Announcement 27
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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 29
Issuance of a Contract 30
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 31
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 The Awardee’s Financial Officer will need to have an account in PCORI Online and be linked to the award to submit and NOTE track their invoices in PCORI Online. 32
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 33
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