Can the principal investigator (PI) listed in the final application differ from the PI listed in the Letter of Intent (LOI)? 

Changes in the PI or institution between the LOI and application phase require prior approval from PCORI’s Program staff prior to submitting the full application. Submit the request to [email protected] and include a rational for the change, letter of support from the intended PI and a CV or biosketch for the replacement PI. Failure to obtain written approval prior to the deadline may result in the application being rejected. 

Can the information proposed in an application differ from the research initially described in the LOI? 

Yes. However, PIs are invited to submit an application based on the information provided in the LOI. Any changes to the following require PCORI's written approval prior to submission: 

  • Principal Investigator 

  • Institution 

  • Study design 

  • Research question(s) 

  • Specific aims 

  • Comparators 

To request approval for any of the above changes, the Principal Investigator and Administrative Official listed on the LOI should email [email protected] and clearly specify the requested change, rationale and impact to the project. Due to the volume of requests PCORI receives, applicants should submit the request early during the application process. 

Are Biosketches required for patient and other stakeholder partners? 

Biosketches are required for all key personnel, whether they are researchers, patients, or other stakeholders. Patient partners have a wealth of experience and wisdom, and we would like them to have an opportunity to provide that background, just as researchers or other stakeholders do. Please use the PCORI Biosketch template developed specifically for patient and stakeholder partners. 

Are preliminary results or pilot studies required to have a successful application? To what extent is it acceptable to propose engagement and/or designs without any prior history? 

There are no explicit requirements regarding pilot data in order to be eligible for PCORI funding. PCORI will consider funding applicants who have not conducted preliminary research or pilot studies. However, it is recommended that applicants who do not include pilot or preliminary data in their applications clearly explain the reason(s) for not including such data. As with any research application, feasibility of key aspects of the research is important to demonstrate, and for some projects, pilot data may be an appropriate way to communicate feasibility of the proposed research plan. 

A history of engagement with the proposed research partners is not required; however, it is encouraged if applicable to the particular study. Prior work with research partners should be noted because these learnings should inform the application. For some studies, demonstrated commitment of patients or other stakeholders may be appropriate; for other studies, a plan for engaging end-users may be appropriate.  

Can I rearrange the order of questions in each section of the Research Strategy Template? 

No. Applicants may not change or reorder the headings, bullets and sub-bullets. Please see the instructions at the beginning of each template for additional instructions. 

Does my application need to address information related to participant randomization, retention or attrition? 

Yes, please be sure to include a plan for the feasibility of the study design, describing how randomization will occur between different sites and locations. Include in the plan evidence showing that patients would be willing to be randomized to specific locations. The proposal should also address participant retention and projected attrition rates. An appropriate attrition rate should be accounted for in final recruitment numbers and included in the power analysis. 

How does the Technical Abstract differ from the Public Abstract? 

Both abstracts should be descriptive of the study being proposed. The Technical Abstract should be written for a scientific audience and can include more technical language. The Public Abstract, however, is meant to be published on the PCORI website when awards are announced. This information regarding proposals is intended for the general public and it should describe the study in layperson terms. 

How is application information submitted using PCORI Online? 

PCORI Online is PCORI's web-based “one-stop shop” for all aspects of the award lifecycle, including LOI and Application submission.  

Start by completing an application using PCORI Online by:  

  1. Entering information into fields provided on the various application tabs. 

  1. Completing and uploading templates provided by PCORI or documents created by the applicant. 

Templates and other instructional documents for completing an application are listed on the PCORI Funding Announcement (PFA) page, which can be found in the Funding Opportunities page. Applicants may find the Pre-Award User Guide for Research Awards useful when navigating the PCORI Online system.  

How should applicants include the methodology standards in the research strategy? 

In the Research Strategy section of the Research Plan Template, applicants should describe in detail the research strategy and plan and should demonstrate how the proposed study is responsive to the PFA. Applicants must complete the PCORI Methodology Standards Checklist and upload it as a single PDF with the Research Plan Template to PCORI Online. 

If a research team member has a National Institutes of Health (NIH) Biosketch, can he or she use this as his or her PCORI Biosketch in the Application? 

Yes, applicants may use a current NIH Biosketch instead of the PCORI Biosketch, but it must not exceed five pages. Applicants are not required to change the font type from Arial (NIH format) to Calibri (PCORI) font if they are using an NIH Biosketch. 

For more information, please be sure to read the Submission Instructions for your specific PFA.  

If an application has 45 subcontract sites, should each PI from each site submit a Letter of Support? Are there any limits to the number of letters that should be included?  

Yes, the PI from each site should write a Letter of Support. There is no limit to the number of Letters of Support that can be submitted with an application.  

For more information, please be sure to read the Submission Instructions (formerly known as application guidelines) for your specific PFA and cycle.  

What is PCORI’s stance on use of a single Institutional Review Board (IRB) in these situations? My IRB states that all multicenter research should use a single IRB as of January 2020 unless the funding agency states that use of a single IRB is not appropriate. 

Currently, PCORI does not have an Institutional Review Board (IRB) Policy, nor do we require investigators to adhere to a single or central IRB approach. Note, however, that if multiple sites are involved in a research application, PCORI expects applicants to demonstrate the likelihood of successful site collaboration, which could include IRB reciprocity or the use of a central IRB. Beyond this, PCORI follows the Federal Policy for the Protection of Human Subjects (45 CFR part 46), including the Common Rule.  

More information on protection of human subjects can be found in our posted PCORI Funding Announcements (PFAs) and Submission Instructions. 

PCORI provides templates for certain portions of the application. Are PIs required to use these templates or can applicants create their own templates? 

PCORI requires applicants to use the templates provided for the current funding cycle. Templates are available to download from the individual PCORI Funding Announcement (PFA) page located in the Funding Opportunities. Please be sure to use the templates for the specific PFA and cycle you are applying to, as templates may vary from PFA to PFA and cycle to cycle. Additional information can be found in the Submission Instructions. 

What are the page-formatting requirements for submitting an application? 

The Submission Instructions and PCORI templates note additional instructions including page or length restrictions, when applicable. Documents uploaded (excluding letters of support) to PCORI Online must be formatted as follows: 

  • Header: Include the PI’s full name in the top left corner of the page header on every page. 

  • Margins: Use at least half-inch margins. The header may fall within the top margin, but the body text should not begin closer than one half-inch from the edge of the page. 

  • Font: Use size 11 Calibri for the main body of the text. Figures, tables and captions may be size 8 font. 

  • Page Numbering: Each page must be numbered consecutively for each PDF upload. Each section of an uploaded document must begin with page 1. 

  • Spacing: Use single spacing. 

  • Document Format: Upload all attachments in PDF format. 

  • Page limit: This varies based on document. 

  • File name format: refer to Submission Checklist. 

  • References: PCORI suggests including all references as in-text citations using American Medical Association (AMA) citation style, but other citation styles are accepted. 

What do I need to include in the Dissemination and Implementation Potential section? 

In this component of up to one page, applicants should describe specific opportunities as well as possible barriers to disseminating and implementing their work in other settings. This section should address any study limitations that could have an impact on the usability of findings (e.g., propriety issues, applicability, scalability and appropriate settings of care).  

PCORI does not support awardees budgeting efforts or resources for the conduct of dissemination and implementation work at this juncture. For projects that produce important findings, PCORI will consider subsequent applications for funding to support dissemination and implementation efforts through separate PFAs and other mechanisms.  

Note: PCORI encourages researchers to submit documentation of any implementation agreement with the sponsoring organization, confirming that the organization will implement successful interventions on a large scale. PCORI will view this agreement as a positive factor during merit review. Include this with the Letters of Support PDF document as the last item. 

What information related to recruitment should I include in my research proposal? 

As applicable, clearly outline the number of sites that will be involved in recruitment and the final recruitment target. The use of a project timeline that tracks expected recruitment over the research period, the potential number of participants that would meet the inclusion criteria and experience with recruiting this population are highly recommended. Applicants are also encouraged to consider whether the proposed recruitment target is adequate, or whether there is a potential to increase the target sample size to power secondary outcomes and heterogeneity of treatment effects (HTE) adequately, if proposed. 

Who needs to have a Profile/Biosketch? 

Scientific principal investigator(s) (up to two) and project team members identified as key personnel contributing to the project in any substantive way are expected to have a complete Professional Profile/Biosketch. The profiles/biosketches must include patients and stakeholders involved as well. PCORI recognizes that not all sections of a Professional Profile/Biosketch will be applicable to patient and stakeholder members of the research team; therefore, applicants are encouraged to fill out the PCORI Patient/Partner Biosketch instead. 

What information should be included in the Scientific Profile/Biosketch? 

The Profile/Biosketch (NIH format or PCORI template) may be up to five pages per individual. PCORI is seeking the following information for each section of the template to learn how previous experience, past performance and training in the field of patient-centered comparative clinical effectiveness research has prepared project team members to conduct this research:  

Education/Training: List all post-secondary education and training, including institution, degree conferred (if any) and year. Include internships, residencies and fellowships, and give beginning and end dates for each. Add or remove lines as necessary.  

Professional/Personal Statement: Briefly describe why your experience and qualifications make you particularly well suited for your role in the proposed project. Limit is 250 words.  

Employment/Positions Held: List all professional positions held since completion of education. Add/remove lines as if necessary.  

Honors: List any honors, including present membership or leadership in relevant organizations or advisory groups.  

Selected Peer-Reviewed Publications: Please limit the list of selected peer-reviewed publications or manuscripts in press to no more than 15 of those most relevant to the project being proposed.  

Other Selected Publications: This can include op-ed pieces, newsletters, blogs and non-peer-reviewed reports. Please list no more than 10 of those most relevant to the project being proposed.  

Project/Study Support: List both selected ongoing and completed projects for the past three years. Begin with the projects that are most relevant to the project being proposed in the PCORI application. Briefly indicate the overall goals of the projects. 

What information should be included in the Patient and Stakeholder Partner Profile/Biosketch? 

Patient and stakeholder partners serving as a PIs must provide biosketch information in either the most recent NIH-formatted biosketch form or by completing the Patient and Stakeholder Partner Profile/Biosketch Template. The Profile/Biosketch (NIH format or PCORI Template) may be up to five pages per individual. Combine the profile/biosketches into a single PDF file and upload the file to the designated field in PCORI Online.  

PCORI is seeking the following information for each section of the template to learn how the backgrounds, previous experience and roles of patient and stakeholder partners are relevant to the proposed project:  

Professional/Personal Statement: Briefly describe why your experience and qualifications make you particularly well suited for your role in the proposed project. Limit is 250 words.  

Experience, Leadership, Engagement: Patient and stakeholder partners are invited to list personal and professional experience relevant to the project/study topic, including participation with community and volunteer organizations and membership or leadership in relevant organizations and advisory groups.  

Engagement in Research/Implementation: Patient and stakeholders are invited to outline past engagement in patient-centered outcomes project/studies, including participation in an advisory capacity, publications authored or co-authored and presentations made. Briefly indicate the role played by the patient and stakeholder partner.  

Other: Please include any additional relevant information to help us better understand the experience and expertise of patient and stakeholder partners for the project. 

What is required in the Project/Performance Site(s) and Resources Template? 

The Project/Performance Site(s) and Resources Template may not exceed 15 pages; use continuation of pages and add additional facilities as needed. Demonstrate in detail that the proposed facilities have the appropriate resources required to conduct the project as planned, within budget and on time.  

Applicants must provide a description of the facilities they will use during the project, including capacity, capability, characteristics, proximity and extent of availability to the project. 

What is the difference between a protocol and the PCORI Research Plan? 

The PCORI Research plan is a key component of an application submission; is directly tied to the executed contract; and contains an overview of the study aims, PICOTs (where applicable; most Methods projects do not include PICOTs), and approach for conducting the study. Once the contract is executed, any changes made to the PCORI Research Plan must be approved by PCORI prior to implementation.  

The study protocol is a document that describes how a clinical research study will be conducted (the objective(s), design, methodology, statistical considerations, and organization of the study) and ensures the safety of the study participants and integrity of the data collected. The study protocol is approved by the study institution and associated IRB, as necessary. Any protocol changes that impact the PCORI Research Plan must be discussed and approved by PCORI. The study protocol might also be included as a key deliverable of a PCORI study milestone.    

What is the difference between the Engagement Plan and the Dissemination and Implementation Potential section? 

The Engagement Plan is designed to capture how applicants plan to involve patients and stakeholders in the research project, while the Dissemination and Implementation section of your research plan should map how research results will be shared. 

What Research Team and Environment information is required in the Research Strategy section of the Research Plan Template? 

For the Team information, describe how the members of the team contribute to the probability of success because of their skills, expertise, connections, etc. This should not duplicate biosketch information. Use this section to describe how this group of individuals will succeed as a team. 

For the Environment information provide more in-depth detail about the capabilities of these sites. Applicants should: 

  • Provide a description of the facilities, including their capacities, capabilities, relative proximity and extent of availability to the project. 

  • Describe how the research environment contributes to the probability of success (e.g., institutional support, physical resources and patient engagement). 

  • Discuss ways in which the proposed study will benefit from the unique features of the research environment or community involvement. 

If none of these criteria applies, explain how the study will employ useful collaborative arrangements in these environments. Finally, describe institutional and community investment in the success of the research. This can include the availability of organized peer groups, logistical support (administrative management and oversight and best practices training), financial support (protected time for research with salary support) and access to and support of patient groups. 

What should be included for milestones in the Milestones Template? 

Milestones are concrete, specific events or accomplishments that are documented by deliverables and associated with a timeline and must include project objectives that will be accomplished at specific times during the proposed project. PCORI encourages applicants to provide three to six milestones per six-month reporting period, though there is no minimum or maximum. Each reporting period should include the major milestones reflecting the research activities and only those activities that the PCORI contract supports. Some examples of milestones include reaching specific patient accrual targets, developing a survey, commencing the intervention and establishing project-specific databases.  

Who should write the Letters of Support and to whom should they be addressed? 

Key personnel and organizations supporting the project should submit Letters of Support. 

All Letters of Support must be addressed to the PI and demonstrate the commitment of key personnel and supporting organizations (e.g., dual-PI, co-PI, co-investigators, consultants, patient and stakeholder partners and stakeholder organizations) to the proposed project. 

Letters of Support are not required for personnel who are not contributing in a substantive, measurable way to the project’s scientific development or execution. However, any group or individual willing to speak for or recommend the research project is also encouraged to complete a Letter.  

All Letters of Support should be consolidated into a single PDF and uploaded into the PCORI Online System, with the Letters of Support Table as the first page of the file.  

For more information, please be sure to read the Submission Instructions (formerly known as application guidelines) for your specific PFA.  

What if I plan on using a research network infrastructure and/or related data resource (such as electronic medical records in healthcare delivery systems or claims data) in my application? 

Applicants intending to use an existing research network and/or data resource should detail in the appropriate sections of the research plan (e.g., study design or approach, study population and setting, or analytical plan as appropriate) the following, as appropriate: 

  • Identify all participating research network entities collaborating on the project and the affiliated study performance sites. 

  • If applicable, describe how data will be managed across study sites within the research network, and whether any dedicated data coordinating functions or facility will be utilized. 

  • All applicants utilizing an existing research network and/or data resource should substantiate in the applications familiarity with the network governance policies or data use restrictions and provide documentation supporting the proposed utilization of the research networks and/or data resources. 

Posted: September 1, 2023

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