Multiple Principal Investigator Award (MPIA)

Overview

About the Cystic Fibrosis Foundation

The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, partnering with the CF community, and advancing high-quality, specialized care. To achieve this mission, various types of grants and awards are offered to support meritorious research in CF.

Multiple Principal Investigator Award (MPIA)

Program and Award Overview

The Foundation’s Investigator-initiated Clinical Research Programs aim to provide support for academic clinical research projects that have the potential to make an important contribution to the CF Foundation’s mission. Academic clinical research projects may address diagnosis, treatment, management of disease or symptoms, or the pathophysiology of CF using clinical (observational or interventional), translational or epidemiologic study approaches.

What the MPI Award intends to do

* Support projects that have multiple-PIs and issue them separate awards
* Fund research that may require the expertise of specialists outside of the CF community or unfamiliar with the disease.
* Provide support for collaborations between researchers with complimentary expertise.
* Help attract new researchers, particularly those in fields that may have limited protected time to conduct research

Each applicant may request funding of up to $200,000 per year for up to three (3) years, plus an additional twelve (12) percent indirect costs per year. Awards may be approved for up to a three (3) year period.

Eligibility

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Application Details

For application technical support, please contact: aminucci@cff.org
Program Name: 2025 Fall - Multiple Principal Investigator Award (MPIA) with LOI
Brief Program Overview/Description: MPI Awards are offered to provide support for investigator-initiated
research projects that require the unique expertise of multiple PIs from different disciplines to conduct the
project successfully. Research projects must have the potential to make an important contribution to the CF
Foundation’s mission. Research projects may be designed to test new hypotheses and/or new methods (Pilot and
Feasibility) OR to advance established results with the potential to address diagnosis, treatment, management of
disease or symptoms, or the pathophysiology of CF using clinical (observational/interventional), translational or
epidemiologic study approaches. Each investigator is expected to be a significant contributor to the project and
share the responsibility and authority for leading and directing the project. Collaborations that bring new
investigators and technologies into the CF research community will be given highest priority.
Funding Amount: Each applicant may request funding of up to $200,000 per year for up to three (3) years, plus an
additional twelve (12) percent indirect costs per year. The lead institution may request up to $25,000 in additional
direct costs per year to support an administrative core.
Eligibility:
• Applicants must speak with program staff prior to submission of a letter of intent to ensure the project design
is in line with the goals of this RFA. Failure to do so will result in the administrative withdrawal of the
proposal.
• United States residents and applicants from outside the United States are welcome to apply.
• At least two (2) but no more than three (3) investigators may be associated with a project.
• Applicants must be independent investigators.
• Applicants must be from a non-profit or academic institution; for-profit entities are not eligible to apply. For-
profit entities should visit Industry Funding Opportunities for more information.
• Additional eligibility requirements can be found in Section IV below.
Key Dates:
Published December 18, 2024
LOI Submission Deadline April 3, 2025
LOI Applicant Notified June 2025
Full Application Deadline August 14, 2025
Committee Review Date October 2025
Notification to Applicants December 2025
Earliest Project Start Date February 1, 2026
Table of Contents:
I. About the Cystic Fibrosis Foundation VII. Review and Award
II. Program and Award Overview VIII. Submission Information
III. Funding Amounts IX. Letter of Intent Guidelines
IV. Eligibility X. Full Application Guidelines
V. Mentorship Requirements XI. Resources and Other Information
VI. Goals of Research Currently of Interest to XII. Contact Information
CFF/Priority Areas XIII. Electronic Application Checklist
*We strongly encourage all applicants pre-register their profile, institution, contacts, and Title of their application at least two
weeks prior to the application deadline. This will help to ensure the CFF Grants & Contracts Management and Administration
(GCMA) Office is able to assist all applicant with any potential system-related queries prior to the Application Deadline.

I. About the Cystic Fibrosis Foundation
The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with CF the
opportunity to lead long, fulfilling lives by funding research and drug development, partnering with the CF
community, and advancing high-quality, specialized care.
To achieve this mission, various types of grants and awards are offered to support meritorious research in CF.
Diversity, Equity, and Inclusion
Cystic fibrosis affects people of different racial and ethnic backgrounds. Diversity, equity, and inclusion (DEI)
are core to our ability to make a meaningful difference in the lives of all people with CF. Improving the
representation of people of color within the CF community – including those in the CF research workforce –
and addressing health disparities that exist within these groups is critical to the Foundation’s mission of
serving all people with CF. Making clinical trial design and engagement more inclusive of people of color with
CF will be critical for improving treatment options and health outcomes for these groups; Black and Hispanic
people with CF account for nearly 30 percent of individuals with rare mutations that are not candidates for
available treatments addressing the underlying cause of the disease. As PIs prepare application materials, we
expect the consideration of how to support inclusion of diverse participants, including plans for building trust
with community members and ensure adequate recruitment of people from diverse backgrounds.
CF Foundation Resources
The Cystic Fibrosis Foundation supports the development of a number of helpful tools and resources to assist
the research community in accelerating the progress toward new scientific knowledge of and new therapies
for cystic fibrosis. For more information on Tools and Resources for the CFF research community, please
visit: https://www.cff.org/Research/Researcher-Resources/Tools-and-Resources/
For more information on Tools and Resources for the CFF research community, please
visit: https://www.cff.org/for-researchers
• CFF Patient Registry Data
• CFF Biorepository
• Community Voice – Getting Community Input
• National Resource Centers
• Whole Genome Sequencing Project Data Requests
II. Program and Award Overview
Program Overview
The Foundation’s Investigator-initiated Clinical Research Programs aim to provide support for academic
clinical research projects that have the potential to make an important contribution to the CF Foundation’s
mission. Academic clinical research projects may address diagnosis, treatment, management of disease or
symptoms, or the pathophysiology of CF using clinical (observational or interventional), translational or
epidemiologic study approaches.
The CF Foundation funds investigator-initiated clinical research through the Clinical Pilot and Feasibility
(CP&FA), Clinical Research Award (CRA), the Clinical Research Award Plus (CRA+), the Multiple Principal
Investigator Award (MPIA), and other various targeted funding opportunities that occur throughout the year.
Funding for any investigator-initiated clinical research award is a tier two process. The CF Foundation requires
CP&FA, CRA, CRA+, and MPIA to submit either a Letter of Intent (LOI) or Concept Proposal in advance of a full
application. Full applications are accepted on an invite-only basis; however, applicants may be able to by-pass
the LOI when resubmitting an application with prior approval from the Program Officer.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Award Overview
MPI Awards are offered to provide support for investigator-initiated research projects that require the unique
expertise of multiple PIs from different disciplines to conduct the project successfully. Research projects must
have the potential to make an important contribution to the CF Foundation’s mission. Research projects may
be designed to test new hypotheses and/or new methods (Pilot and Feasibility) OR to advance established
results with the potential to address diagnosis, treatment, management of disease or symptoms, or the
pathophysiology of CF using clinical (observational/interventional), translational or epidemiologic study
approaches. Each PI should be working together to address a single overarching research
question/hypothesis.
Each investigator is expected to be a significant contributor to the project and share the responsibility and
authority for leading and directing the project. Each investigator should bring unique expertise to the project-
in most cases, we expect to see investigators from distinct subspecialties or research disciplines collaborating
for these awards. Investigators are expected to be thought partners on the proposed work, with each
applicant carrying a nearly equal role in the conduct of the work, and fundamental to the ability to address
the research question. The MPIA should not be used to support multi-site studies where one PI’s role is solely
to support enrollment, provide samples or data, or serve in a consulting role (please see the CRA or CP&FA
RFAs for these projects). Collaborations that bring new investigators and technologies into the CF research
community will be given highest priority. We strongly encourage investigators to use this award mechanism
to launch interdisciplinary collaborations.
What the MPI Award intends to do:
• Support projects that have multiple-PIs and issue them separate awards
• Fund research that may require the expertise of specialists outside of the CF community or unfamiliar
with the disease
• Provide support for collaborations between researchers with complimentary expertise
• Help attract new researchers, particularly those in fields that may have limited protected time
to conduct research
What the MPI Award does NOT intend to do:
• Support multi-center clinical studies where one PI is considered the “lead”
• Support multi-site studies where one PI’s role is solely to support enrollment, provide samples or
data, or serve in a consulting role
• Support clinical research trials for drug development
III. Funding Amount
• Each applicant may request funding of up to $200,000 per year for up to three (3) years, plus an
additional twelve (12) percent indirect costs per year.
• Awards may be approved for up to a three (3) year period. Funding for Year 2 and Year 3 is contingent
upon submission and approval of a renewal progress report and the availability of funds.
• The lead institution may request up to $25,000 in additional direct costs per year to support an
administrative core. Administrative core duties should include activities to facilitate communication and
data sharing between individual PIs.
Direct costs may be requested for:
• Salaries and Benefits
• Research supplies
• Equipment
• Research-related subject costs
• Consultant costs
• Support for multidisciplinary collaborations, including travel
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

• Travel costs for scientific/technical meeting(s)
• Tuition
Indirect Costs up to twelve (12) percent may be requested from CFF. Indirect costs may be requested for all
expenses except for the following:
• Equipment (items over $5,000 in value)
• Computer software
• Software licenses
• Tuition
*Applicants may request indirect costs on the first $25,000 of each subcontract for the project period.
IV. Eligibility
• Applicants must speak with program staff prior to submission to ensure the project design is in line with
the goals of this RFA. Failure to do so will result in the administrative withdrawal of the proposal.
• At least two (2) but no more than three (3) investigators may be included in a given award.
• United States residents and applicants from outside the United States are welcome to apply.
• Applicants must be independent investigators. An independent investigator is an individual who is out of
fellowship training and whose institution allows them to submit applications for research funding as a
Principal Investigator.
• Candidates who are clinical fellows should apply to the CFF Clinical Fellowship program for the
appropriate year.
• Candidates who are postdoctoral fellows should apply to the CFF Postdoctoral Research Fellowship
program.
• Applicants must be from a non-profit or academic institution; for-profit entities are not eligible to
apply. For-profit entities should visit Industry Funding Opportunities for more information.
V. Mentorship Requirements
Not applicable to this RFA
VI. Goals of Research Currently of Interest to CFF/Priority Areas
The Cystic Fibrosis Foundation regularly assesses its key research priorities to ensure we are on track to
accomplish our mission to cure CF and to provide people with CF the opportunity to lead long lives.
Applicants are encouraged to align submissions to the 2025 MPI Award Topics but can submit proposals
that address other CFF key research priorities. Applications that do not align with '2025 MPI Award Topics'
but are captured in the 'Areas of Encouragement' require approval from the program officer (to ensure that
the work is not duplicative of ongoing funded research
Key research priorities and Areas of Encouragement for applicants are outlined in further detail on
https://www.cff.org/Research/Researcher-Resources/Awards-and-Grants/Applicant-Resources/Key-Research-
Priorities-for-Applicants/ .
2025 MPI Award Topics
• MICROORGANISM DETECTION: Research that advances novel microbial detection and diagnostic
techniques that meet the needs of the CF community.
• ANTIMICROBIAL MANAGEMENT: Research related to the optimization of current antimicrobial
therapies (e.g., treatment approaches, long-term impacts of therapies, antimicrobial stewardship,
mechanisms of resistance, and eradication) in the current post-modulator population.
• LIVER & PANCREAS: Research related to the screening and monitoring for pancreatic and liver
disease/complications, approaches to detect and treat non-cirrhotic portal hypertension, approaches
for screening and detecting cancer, and to evaluate advanced liver disease.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

• NEUROCOGNITIVE FUNCTIONING: Research related to advancing the general understanding of
neurocognitive function in CF, including research to understand the impact of modulators on
neurocognitive and mental health outcomes.
• CF-RELATED DIABETES (CFRD): Research related to understanding the interplay between
endocrine/exocrine pancreas and other organs (i.e. liver, gut) on the development and progression of
CFRD, discovery and validation of novel biomarkers of disease progression, and development of
personalized treatment approaches, including when to initiate treatment.
• GUT HEALTH: Research related to addressing gastrointestinal (GI) complications (e.g., GI symptoms,
cancers, and nutritional health), including the development of relevant endpoints to study gut motility
(e.g., gastroparesis).
• GENETIC-BASED THERAPIES: Research related to biomarker or outcome measure development in
support of research and development of genetic-based therapies
More information regarding the research priorities of the CF Foundation can be found here. For specific
questions regarding your proposal and the CFF’s research priorities, please contact the Program Officer, Dara
Riva (driva@cff.org).
VII. Review and Award
Applications to the Clinical Research Program are reviewed by the Clinical Research Committee (CRC),
community representative reviewers, and the CFF.
Applications undergo scientific peer-review by the CRC and receive scores based on scientific merit and
synergy. The importance of the study topic and the potential impact of new knowledge in the area will be
considered when prioritizing projects for funding. Applications will be evaluated on their experimental design
and methods, rationale, statistical analysis methodology, and collaboration plan. Applicants should
adequately describe how the hypothesis will be tested, demonstrate adequate power for testing the
hypothesis, and clearly define all variables in their statistical analysis section. Applicants are required to
consult with a biostatistician prior to submitting their proposals. In addition, applicants are required to include
a biostatistician with a minimum of 5% effort on their project. The collaboration plan will be a fundamental
part of the application; proposals that do not include clear communication and data integration plans, or
adequately describe the importance of each investigator’s expertise in the project will not be successfully
funded.
Community representative reviewers evaluate applications based on study design and feasibility from the
perspective of people with CF, including potential barriers for study participation. They also evaluate the
project on its relevance to the CF Foundation’s mission and the project’s potential to impact those living with
CF. Community representative reviewers do not review an application for scientific merit. Reviews from the
community representative reviewers are used to inform funding decisions.
Funding of awards is approved by the CFF Board of Directors and is based on the availability of funds, priority
score assigned to each application, and recommendations of the CRC, community representative reviewers,
and CFF Program Officers. All awards are subject to compliance with applicable regulations and CFF policies.
Chief reasons for assigning low priority scores to applications during review include the following:
• Incomplete application: Each PI is responsible for submitting a portion of the full application on
https://awards.cff.org. See Section X. Full Application Instructions for more details
• Insufficient information or documentation
• Inadequate statement of hypothesis, inadequate experimental design, inadequate analytic methods, or
experimental plan that does not address hypothesis
• Failure of the applicant(s) to describe potential relevance of the proposed study to address issues or
knowledge gaps in CF
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

• Failure of the applicant(s) to document the necessary skills, training, or collaborate with individuals with
the relevant expertise to accomplish the goals of the proposal
• Failure of the applicant(s) to provide sufficient preliminary data to support the proposed research
methods and approach
• Failure of the applicant(s) to demonstrate adequate level of support and appropriate plan for
data acquisition, management, and statistical analyses
• Failure of the applicant(s) to meet all the criteria described in these guidelines
• Failure to adequately describe the collaboration plan and how separate projects address a common
scientific theme
• Failure of the applicant(s) to demonstrate unique talents or expertise that each PI brings to the project
CFF may withdraw applications receiving low scores, and/or those deemed nonresponsive to the program
announcement before the CRC review meeting. In these cases, CFF will notify applicants if their application
has been withdrawn without discussion. Applications that have not been discussed in two review meetings
will not be accepted for further consideration by CFF. Applicants must address reviewer critiques in order to
resubmit their applications during future application cycles.
VIII. Submission Information
A Letter of Intent (LOI) must be submitted and approved prior to submitting a Full Application
Applicants may only submit one LOI and one full application per cycle.
Submit online at https://awards.cff.org
(Refer to Section IX and X of these guidelines for specific submission instructions)
An application will be considered incomplete if it fails to comply with the instructions, or if the submitted
material is insufficient to permit adequate review. CFF reviews applications electronically, and only
documents submitted online at https://awards.cff.org will be reviewed.
Specific requests regarding a deviation from these guidelines must be submitted to the Program Officer
Dara Riva (driva@cff.org) for approval prior to submitting their application.
General Timeline:
Published December 18, 2024
LOI Submission Deadline April 3, 2025
LOI Applicant Notified June 2025
Full Application Deadline August 14, 2025
Committee Review Date October 2025
Notification to Applicants December 2025
Earliest Project Start Date February 1, 2026
*We highly encourage that you pre-register your profile, institution, contacts, and Title of your Application by
this date. This will confirm that your submission at the Application Deadline, is without any system-related
issue. It will also allow us to assist you on system-related queries before the Application Deadline. This pre-
registration is for new applicants to the system and will only need to be completed once.
IX. Letter of Intent Guidelines
LOIs Submission Deadline: Thursday, April 3, 2025 at 5:00 PM (EST)
Applications must be submitted online at https://awards.cff.org
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Only one Letter of Intent (LOI) needs to be submitted per project. Upon invitation to a full application, each
investigator identified at the LOI stage will receive a separate invitation for a full application. Required
submission materials for each investigator are indicated below in Section X. Full Application Instructions.
Documents should be typed using:
• Font: Times New Roman 12 or Arial 11
• Margins: No less than a half inch on each side
Note: When all the documents have been uploaded to awards.cff.org, the system will compile them into a
single PDF file. You may preview this file by selecting “LOI Application Full Print”, as well as exporting the
compiled PDF file.
To login, please visit: https://awards.cff.org
For all first-time applicants in the new Grants Management System, we ask that you pre-register to create a
username and password for “http://awards.cff.org” and complete a profile well before the date you plan to
submit an application. We also request that as you begin your application, you enter the title of your project,
if available. If you are registered and cannot remember your password, click on the “Forgot Password?” link
below the “Login” fields.
Once logged in, the award opportunities, including this Request for Applications (RFA), will be listed in the
Funding Opportunities tab on the opening screen.
Locate the listing for the “2025 Fall - Multiple Principal Investigator Award (MPIA) with LOI” program. Click
on the “Apply” button in the column on the far right to open the application form.
Applicants may stop at any point but must click the “Save” button at the bottom of each page before exiting
in order to save their progress. When you wish to return to your draft application, please do not go through
the “Funding Opportunities” tab. Instead, go to the “My Applications” tab in the right corner of the main
page. When you are in the “My Applications” tab you will be able to find all your draft applications by clicking
on the “Draft Applications” module.
The following sections are displayed as tabs across the application screen. Click on each section and follow the
directions. Click “Save” as you complete each section.
GENERAL
Enter the title of your project, enter the project start and end dates, select the number of periods being
requested, and complete any additional questions. Also, please complete the organizational assurances
indications (i.e. IRB, IACUC, and/or IBC/rDNA approval letter and status at the time of submitting the
application) in this section.
Note: The project title should start with the last name of the primary PI (i.e. if the PI submitting the LOI and
leading the project is John Smith, the project title should be “Smith – XYZ”).
CONTACT PROFILE
If a profile was completed upon registration, the fields in this section will already be populated with the
information entered in your Professional Profile. If you need to make any changes, you may update your
profile in this section.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Once updated you must “Save and Validate” prior to returning to continue your submission
INSTITUTION
If a profile was completed upon registration, the applicant’s/principal investigator’s institution will be pre-
loaded as the Lead Institution. Domestic applicants must verify their institution by entering the Employer
Identification Number (EIN) or Tax Identification Number (TIN) to search the system for the correct institution.
You may find your EIN by referencing the Institutional W-9 or equivalent documentation. If the EIN/TIN is not
located in our system, you have the option to add the legal institution. Please also confirm if the project site
is the same as the legal institution.
Verification of Applicant Institution’s Tax Status (upload as PDF documents):
The CFF Grants & Contracts Management and Administration (GCMA) Office must have a copy of the
applicant institution’s current W-9 and 501(c)3 letter, or other documentation verifying its Federal tax status
and will not issue Award Letters to Awardees if these documents are not received and on file.
• Non-U.S. applicants must provide a copy of the W-8BEN-E form (required). In addition, a tax equivalency
letter should be uploaded, if available. If a tax equivalency letter is not available, applicants must upload
a letter stating this documentation is not available.
International Applicants (if applicable):
For international applicants, you will need to answer an eligibility question specifying if you are an
independent investigator. If answering yes, CFF may require an additional letter of support to be added to
the application to verify eligibility.
CONTACTS
Please note: The INSTITUTION tab must be completed prior to adding internal contacts to ensure that the
contacts are properly associated with the applicant institution.
Complete the required contact fields by searching by name for existing contacts at your institution for each
role. If the desired institutional contact is not available in the system, you may select “Add Internal Contact”
to create a basic contact profile in order to add the individual to your application.
Additional contacts not associated with the applicant institution may also be added. These contacts are
considered additional contributors involved in the proposed research plan. These may include consultants,
collaborators, or subcontractors. In order to add contacts external to the applicant institution, please select
the appropriate “Add Subcontractors” or “Add Consultants/Collaborators” button(s) and add the contacts in
the table, then click “Save”.
ABSTRACTS/RELEVANCE
In the space provided online for each abstract, provide a statement of no more than 2,000 characters
(including spaces) explaining the subject of the research proposal and its relationship to CF. Two different
abstracts are required, as follows:
• Lay Abstract: This statement will be used to inform the non-scientific departments of CFF and the general
public of the nature of this work. Applicants should not include any confidential or proprietary
information, including intellectual property, in the lay abstract.
• Scientific Abstract: This statement will be used to inform the scientific community.
• Summary of Relevance to CFF mission: All applications are reviewed and scored not only on scientific
merit but also on relevance to CFF’s mission:
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with
CF the opportunity to lead long, fulfilling lives by funding research and drug development,
partnering with the CF community, and advancing high-quality, specialized care.
Provide a statement of no more than 3,000 characters (including spaces) summarizing the relevance of
the proposed research to the health and well-being of CF patients, for a scientific audience who may or
may not have a background in the subspecialty of the proposed research.
BUDGET
• Select the “Open” button under the Budget tab and complete the relevant budget categories for each
year of funding. Fill in the applicable amounts for each year of support requested by completing the
online fields (Period 1, 2, 3). All Multi PI Clinical Research Awards are awarded for a maximum of three (3)
years, up to $200,000/year in direct costs (plus an additional 12% indirect costs) per investigator.
• The lead institution may request up to $25,000 in additional direct costs per year to support an
administrative core. Administrative core duties should include activities to facilitate communication and
data sharing between individual PIs. Only one application per team may request this supplement.
• The estimated total project budget (for all PIs) should be provided in the LOI.
Be sure to click “Save” prior to closing the budget window.
LOI UPLOADS
Download the available templates applicable to the project, upload the completed templates in PDF format to
the corresponding attachment types within this section. Templates available for download include:
• Biographical Sketch(es) of Key Personnel
• Budget Justification
• LOI Project Description
• LOI Collaboration Details
• LOI Critique Response (if applicable)
• CFF Patient Registry Data Request (if applicable)
• CFF Biorepository Clinical Specimen Confirmation Letter (if applicable)
Biographical Sketch(es) of Key Personnel (NIH template available for download)
CFF defines “key project personnel” as any individual with an advanced degree who will play an instrumental
role in the research project. An NIH Biographical Sketch form should be completed for each key project
personnel and uploaded as PDF. The maximum length for each biosketch is five (5) pages. Personnel must
include a biostatistician with a minimum of 5% effort per year of the entire project period.
LOI Budget Justification (template available for download)
Describe the estimated costs listed in the Budget Detail. Use major categories, such as Salary & Benefits,
Consultant Costs, Major Equipment, etc. In this justification clearly define what estimates apply to each
investigator. LOI Budget Justification will need to include the budget summary for all potential PI’s.
LOI Project Description (template available for download)
Upload a PDF copy of the completed document. Maximum of three (3) pages (not including the literature
cited). Components should include:
• Statement of Hypothesis and Specific Aims: State concisely and realistically the intent of the proposed
research and the hypothesis to be tested. Each PI should be working together to address a single
overarching research question/hypothesis. The specific aims should both test this stated hypothesis and
be relevant to the mission of the Cystic Fibrosis Foundation.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

• Brief Study Design: Briefly describe the research design and methods for achieving the specific aims.
Include any pertinent preliminary data to support the rationale and feasibility of the proposed study, the
hypothesis being tested, and the selection of outcome measures and timepoints. Briefly describe the
eligibility criteria, recruitment and retention processes, study procedures (including participant and study
timeline), and study outcomes and other measures. Include a brief statistical section describing
methodologies and any confounders or demographic variables that will be considered during analysis.
• Literature Cited: References should be numbered in the sequence that they appear in the text. Each
citation must include the names of authors, the name of the journal or book, volume number, page
number and year of publication (titles are optional).
LOI Collaboration Details (template available for download)
List all project PIs and institutions, as well as their overall role in the study. Discuss in detail the advantages of
addressing this problem through the combined expertise of the PIs and how this contributes to the synergy of
the application. Describe how the proposed partnership involves a substantial contribution by each
investigator and the reciprocal flow of ideas and information. Describe how the combined efforts of the PIs
will result in a level of productivity that is greater than that achievable by each PI working independently.
Letters of Support
At least one (1) Letters of Support is required:
• Provide a cosigned letter, or letters from each of the intended investigators, confirming a commitment to
this project and an intent to submit full applications if the LOI is invited.
Critique Response (template available for download, if applicable)
Only one Critique Response needs to be developed per team. This document should be uploaded to the LOI.
For resubmissions: Provide a point-by-point response to the prior reviews.
Please be concise and succinct. Beginning in 2018, applicant’s will only be allowed to revise and resubmit their
full application for a specific project one time unless granted permission from the CFF Program Officer.
Maximum three (3) pages
CFF Patient Registry Data Request (if applicable)
CF Foundation Patient Registry. Applicants whose project will include requesting data from the CF Foundation
Patient Registry should check the appropriate box. It is not necessary to check the box for single site studies
or studies acquiring Registry data from the biorepository. Please note: if the LOI is approved for full
submission, the applicant will need to submit the project for review by the Registry / Comparative
Effectiveness Research (CER) committee prior to grant submission. Instruction regarding submission for
review are located at: https://www.cff.org/Research/Researcher-Resources/Tools-and-Resources/Patient-
Registry-Data-Requests/
CFF Biorepository Clinical Specimen Confirmation Letter (if applicable)
To request clinical samples from the CFF Biorepository to use in the proposed study, please follow the
following steps:
1. Visit https://www.cff.org/researchers/cf-foundation-biorepository#biobanked-samples-available to
identify potential sample fit and download request form.
2. Submit clinical specimen inquiry form to ezagnit@cff.org at least six weeks prior to LOI submission.
You will receive documentation confirming receipt of your request and that the sample request is
feasible from the Sr. Clinical Research Development Specialist. This should be submitted with your
LOI.
3. Should you be invited to submit a full application, you must connect with the Sr. Clinical Research
Development Specialist and finalize your sample request no less than 6 weeks prior to the Full
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Application deadline (2 January 2024, 2 July 2024). *Late requests may not be processed in time for
submission of materials to the CRC.*
4. A letter documenting available sample counts and other pertinent biorepository details, and
confirming access to samples pending CFF funding will be provided by the Sr. Clinical Research
Development Specialist for submission with the Full Application. *Applications without this
documentation may have funding held OR may be downgraded during review due to lack of CFF
Biorepository support.*
Note: Applicants must upload the confirmation letter provided by the CFF Sr. Clinical Research Development
Specialist to the application. Funding is contingent upon approval and availability to access clinical specimens.
Submission
Prior to selecting “Submit”, please complete a thorough review of the entire LOI. The “Submit” button will
trigger validation on all required fields and identify any errors.
X. Full Application Guidelines
Full Application Deadline: Thursday, August 14, 2025 at 5:00 PM (EST)
A Letter of Intent (LOI) must have been submitted and approved prior to receiving an invitation to proceed
with a Full Application.
Applications must be submitted online at https://awards.cff.org
Documents should be typed using:
• Font: Times New Roman 12 or Arial 11
• Margins: No less than a half inch on each side
Note: When all the documents have been uploaded to awards.cff.org, the system will compile them into a
single PDF file. You may preview this file by selecting “Application Full Print”, as well as exporting the
compiled PDF file.
To login, please visit: https://awards.cff.org
If the LOI submission is approved to proceed to a full application submission, the application will have already
been pre-loaded in the system for each of the pre-identified PIs. Log in with your existing credentials to access
the application.
Your draft application will by listed under “My Applications”, then within the “Draft Applications” section.
Upon locating the draft application, you may select it to begin your submission.
Applicants may stop at any point but must click the “Save” button before exiting in order to save their
progress.
The following sections are displayed as tabs across the application screen. Click on each section and follow the
directions. Click “Save” as you complete each section.
Please note: Only select the “Sign & Submit to AIO” button after the application has been fully completed.
This will trigger validation on all required fields and send the application to your Authorized Institutional
Official “AIO” for review and signature.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

GENERAL
Enter the title of your project, enter the project start and end dates, select the number of periods being
requested, and complete any additional questions. Also, please complete the organizational assurances
indications (i.e. IRB, IACUC, and/or IBC/rDNA approval letter and status at the time of submitting the
application) in this section.
*Please ensure that you review and comply with the Organizational Assurances and Certifications as cited
below.
Secondary PIs should ensure that the title of their application is identical to the title of the approved LOI.
Note: The project title should start with the last name of the primary PI (i.e. if the PI submitting the LOI and
leading the project is John Smith, the project title should be “Smith – XYZ”).
CONTACT PROFILE
If a profile was completed during the LOI, the fields in this section will already be populated with the
information entered in your Professional Profile. If you need to make any changes, you may update your
profile in this section.
Once updated you must “Save and Validate” prior to returning to continue your submission.
INSTITUTION
If a profile was completed upon registration, the applicant’s/principal investigator’s institution will be pre-
loaded as the Lead Institution. Domestic applicants must verify their institution by entering the Employer
Identification Number (EIN) or Tax Identification Number (TIN) to search the system for the correct institution.
You may find your EIN by referencing the Institutional W-9 or equivalent documentation. If the EIN/TIN is not
located in our system, you have the option to add the legal institution. Please also confirm if the project site
is the same as the legal institution.
Verification of Applicant Institution’s Tax Status (upload as PDF documents):
The CFF GCMA Office must have a copy of the applicant institution’s current W-9 and 501(c)3 letter, or other
documentation verifying its Federal tax status and will not issue Award Letters to Awardees if these
documents are not received and on file.
• Non-U.S. applicants must provide a copy of the W-8BEN-E form (required). In addition, a tax equivalency
letter should be uploaded, if available. If a tax equivalency letter is not available, applicants must upload
a letter stating this documentation is not available.
International Applicants (if applicable):
For international applicants, you will need to answer an eligibility question specifying if you are an
independent investigator. If answering yes, CFF may require an additional letter of support to be added to
the application to verify eligibility.
CONTACTS
Please note: The INSTITUTION tab must be completed prior to adding internal contacts to ensure that the
contacts are properly associated with the applicant institution.
If added during the LOI, this will be pre-populated but can be changed during the full application. Complete
the required contact fields by searching by name for existing contacts at your institution for each role. If the
desired institutional contact is not available in the system, you may select “Add Internal Contact” to create a
basic contact profile in order to add the individual to your application.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Additional contacts not associated with the applicant institution may also be added. These contacts are
considered additional contributors involved in the proposed research plan. These may include consultants,
collaborators, or subcontractors. In order to add contacts external to the applicant institution, please select
the appropriate “Add Subcontractors” or “Add Consultants/Collaborators” button(s) and add the contacts in
the table, then click “Save”.
REFERENCES
CFF defines “junior investigator” as any individual who has not received a CFF/CFFT Research Grant or NIH
equivalent (e.g. R01, R21, R23) as a Principal Investigator AND is within their first five years of their first
academic appointment at the level of Assistant Professor or equivalent.
Applicant is NOT considered a junior investigator if they meet one or more of the below criteria:
• More than five years after their first academic appointment at the level of Assistant Professor (or
equivalent)
• Has received a CFF/CFFT Research Grant or NIH equivalent (e.g., RO1, R21, R23)
• Has been promoted to Associate Professor or higher
Letters of Reference for junior investigators must be submitted by the following individuals:
• The Chair of the applicant’s department at the applicant Institution – The letter of reference from the
Department Chair should indicate the release of sufficient space and facilities for the work described, as
well as guarantee the time commitment of the investigator to the project. If the applicant is currently a
fellow, the letter of reference should include confirmation of the pending faculty-level appointment.
• At least two other individuals familiar with the applicant's scientific interests and abilities.
Letters of Reference must be submitted prior to submission of the application. To invite Referees, go to the
“REFERENCES” tab of the online application, then select the blue button to open a pop-up window in order to
add the referees in the table. You must click “Invite” in order to trigger the e-mail to the referee. The
referee(s) will be sent an e-mail asking them to Accept or Decline the invitation to submit a letter of reference
and will be provided instructions to submit the letter. The applicant will not be alerted if a referee Declines
the invitation; please make sure to check this tab regularly to see the status of the references. The applicant
should inform Referees to submit the letters at least one (1) week prior to the application deadline. This helps
to ensure that the letters have been uploaded before the application is submitted. Once the application has
been submitted, no documents can be added.
Letters uploaded to http://awards.cff.org should not be password protected or otherwise encrypted. Such
encryption will cause errors in assembling a single-print PDF of the application. The applicant should inform
the individuals writing letters to not include password protection on their documents.
*Senior investigators, or those who have received a prior CFF/CFFT Research Grant or NIH equivalent, are
not required to submit Letters of Reference; however, if they are new to CF research, Letters of Support
and/or Collaboration should be provided and uploaded as Appendices.
ABSTRACTS/RELEVANCE
In the space provided online for each abstract, provide a statement of no more than 2,000 characters
(including spaces) explaining the subject of the research proposal and its relationship to CF. Two different
abstracts are required, as follows:
• Lay Abstract: This statement will be used to inform the non-scientific departments of CFF and the general
public of the nature of this work. Applicants should not include any confidential or proprietary
information, including intellectual property, in the lay abstract.
• Scientific Abstract: This statement will be used to inform the scientific community.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

• Summary of Relevance to CFF mission: All applications are reviewed and scored not only on scientific
merit but also on relevance to CFF’s mission:
The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with
CF the opportunity to lead long, fulfilling lives by funding research and drug development,
partnering with the CF community, and advancing high-quality, specialized care.
Provide a statement of no more than 3,000 characters (including spaces) summarizing the relevance of
the proposed research to the health and well-being of CF patients, for a scientific audience who may or
may not have a background in the subspecialty of the proposed research.
BUDGET
Select the “Edit Budget” button under Application Budget, to enter and begin completion of the application’s
budget detail for each year of funding being requested. Awards funded through this RFA are for a maximum
of three (3) years.
• For each PI, the budget may not exceed $200,000 in direct costs per year (plus 12% indirect costs) for a
maximum of three (3) years. This amount is inclusive of the cost of any subcontracts. The lead institution
may request up to $25,000 in additional direct costs per year to support an administrative core (see Other
Expenses).
• Each PI must submit a budget and justification specific to their own portion of the effort as part of their
separate https://awards.cff.org application packages. The Budget for the initiating PI should not include
budget information for the partnering PIs, even if they are at the same organization.
• Applicants are required to include a biostatistician with a minimum of 5% effort per year of their project.
• Services that are part of routine medical care (as defined by the U.S. Department of Health and Human
Services) may not be included in the project budget. Whenever possible, the price of services (e.g., X-rays,
EKGs, PFTs, etc.) provided by the institution should be negotiated to the lowest possible non-profit price.
• Separate professional fees for interpretation of data (e.g., from X-rays, lab tests, PFTs) may not be
included when such interpretation is performed by the named investigator(s), co-investigator(s), or
consultants as part of the project, other than in exceptional circumstances. In such cases, justification for
these fees must be described in detail in the budget justification template.
• Under most circumstances, hospitalization costs of study subjects cannot be included in this budget.
The following budget categories are offered under this program:
Salaries & Benefits - List the names, positions, and percent effort of all professional and non-professional
personnel involved in the project, whether or not salaries are requested. For each individual, be sure to
complete all fields on the Budget Detail in full on the template provided. In accordance with National
Institutes of Health (NIH) policy, salary requests may not use an institutional base salary in excess of the
current federal salary cap (FY2024) of $221,900. Fringe benefits may be requested if they are treated
consistently by the applicant institution as a direct cost to all funding agencies and foundations.
Consultant Costs - Give the name and institutional affiliation of any consultant who has agreed to serve in
this capacity, including statisticians and physicians in connection with the project if they are not listed under
personnel. In the budget justification, briefly describe services to be performed, the number of days, rate of
compensation, per diem and any other associated costs. Qualifying consultants are individuals that are
generally not employed at the applicant institution and/or are consulting independently to the project.
Travel – Describe the purpose of any CF-relevant travel. Please note: expenses for travel outside the North
American Continent, including travel to Hawaii, Puerto Rico, and other U.S. territories are not allowable
expenses without prior written approval from the CFF GCMA Office with the exception of travel for speaking
engagements at the European Cystic Fibrosis Conference to present data obtained through a CFF funding
opportunity. Travel expenses may not exceed $2,000 per person, per year. Additional travel expenses may be
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

requested and will be considered on a case-by-case basis. Registration fees associated with conferences
should be listed under “Other Expenses.”
Consumable Supplies - Itemize supplies e.g. glassware, chemicals, animals, in separate categories and give
the estimated cost of each category. If animals are involved, state the number, unit purchase cost, and unit
care cost.
Major Equipment - List all items of equipment greater than $5,000 requested and the cost of each item. If
funds are requested to purchase equipment that is equivalent to items listed under “Facilities Available”,
justify the duplication. Justify any item of equipment for which the need may not be obvious.
Other Expenses - Itemize other expenses by major categories, such as duplication costs, publication costs,
minor equipment (under $5,000), computer charges, conference registration fees, other research costs (e.g.,
recruitment flyers, brochures, patient travel cost reimbursement, translation of patient facing materials, and
reasonable patient stipends for participation), etc. Tuition costs may be requested for personnel supported
through this study but may not exceed $10,000 per person per year. The lead institution may request up to
$25,000 in additional direct costs per year to support an administrative core. Administrative core duties
should include activities to facilitate communication and data sharing between individual PIs. Please justify all
items listed.
Patient Research Costs – Funds may be requested for patient research costs specifically related to the
proposed research. The basis for estimating funds requested in this category must be justified and applicants
must provide detailed information regarding the proposed costs (e.g., number of procedures, cost per
procedure, ancillary costs). The scientific need for patient research costs will be considered in the review.
Negotiation of these costs are between the applicant institution and the service provider. Please note costs
associated with patient recruitment and/or reimbursement for study participation should be included in
“Other Expenses” section.
If approved as part of the application, patient research costs are capped at the amount requested in the
budget and under no circumstances is CFF responsible for any costs that are later determined non-covered by
third party insurers. Applicants and applicant institutions acknowledge that CFF is solely a provider of funding
for the research performed under an approved award and not a sponsor of the research as defined by the
FDA (21 CFR §312.3(b)).
Subcontractor Summary
Partnering investigators should not be subcontractors on a fellow investigator's budget. All costs
associated with partnering investigators should be listed within each of their individual budgets.
If applicable, detailed budgets and budget justifications for each subcontract, including indirects, must be
provided for each year of support. Subcontractors are added in the prior section entitled CONTACTS. The
lead/prime applicant (PI) and/or Grants Officer can initiate/complete the subcontract budget. After adding
Subcontractor(s), in order to access the subcontract budget activity, please select the “BUDGET” tab of the
application and click the “Open” button next to each listed subcontractor. After completing the subcontract
budget activity, please select “Pending PI Acceptance”, as well as “Submit” to ensure the subcontractor
budget is included as part of the main application budget.
For applications that include a subcontract with a third party, the applicant may request indirect costs on the
first $25,000 of each subcontract per project period. Negotiations of subcontracts are between the applicant
institution and the subcontractor.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Budget Detail – Indirect Costs
Indirect costs of up to twelve (12) percent may be requested from CFF. Indirect costs may be requested for
all expenses except for the following:
• Major equipment (items over $5,000 in value)
• Computer software
• Software licenses
• Tuition
LOI UPLOADS
This section will allow access to the documentation uploaded at the LOI stage. If you were invited directly to
the full application, this section will not include LOI uploads from the original LOI submission.
FULL APPLICATION UPLOADS
Download the available templates applicable to the project, upload the completed templates in PDF format to
the corresponding attachment types within this section. Please note that some uploads may be created as a
single document and uploaded to each full application. Each full application should have all required
components uploaded; however, some documents can be developed per team.
Templates available and to be developed per team:
• Collaboration Details - Partnership Statement and Communication Plan - Only one collaboration detail
needs to be developed per team. This document should be uploaded to each full application.
• Research Plan – Only one research plan should be developed per team. This document should be uploaded
to each full application.
• Statement of Work – Only one statement of work needs to be developed per team. This document should
be uploaded to each full application.
• Critique Response (LOI or resubmission, if applicable) Only one Critique Response needs to be developed
per team. This document should be uploaded to each full application. Do not provide different content for
each PI, as only one Critique Response upload will be reviewed per team.
Templates available and to be provided per PI:
• Protocol Synopsis, Schedule of Events, and Participant Reimbursement – A single or multiple protocol
synopses can be developed based on the nature of the project.
• Budget Justification
• Biographical Sketches of Key Personnel
• Other Support
• Facilities Available
• Data Safety Monitoring Plan - One single or multiple DSMP(s) can be developed based on the nature of the
project
• CFF Patient Registry Data Request Application (if applicable)
• CFF Biorepository Clinical Specimen Confirmation Letter (if applicable)
• International Institution Form (if applicable)
Collaboration Details - Partnership Statement and Communication Plan (template available for download)
• At the top of each page, type the PI's name. Each page must be sequentially numbered at the bottom.
Partnership Statement and Communication Plans are limited to three (3) single-sided pages.
Applications exceeding this page limit will not be reviewed. Only one Collaboration Details needs to be
developed per team. This document should be uploaded to each full application. Do not provide
different content for each PI, as only one Collaboration Details upload will be reviewed per team.
• Discuss in detail the advantages of addressing this problem through the combined expertise of the PIs and
how this contributes to the synergy of the application. Describe how the proposed partnership involves a
substantial contribution by each investigator and the reciprocal flow of ideas and information. Describe
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

how the combined efforts of the PIs will result in a level of productivity that is greater than that
achievable by each PI working independently.
• In regard to the planned communication for the project, this document should clearly outline:
a. How research activities will be coordinated among investigators.
b. How data will be integrated and shared among investigators.
c. How the collaborative nature of the program will be maintained.
d. How reagents, equipment, resources and data will be shared within the program.
e. How conflict and scientific disagreements will be managed and resolved.
Research Plan (template available for download)
• Only one research plan should be developed per team. This document should be uploaded to each full
application.
• At the top of each page, type the PI's name. Each page must be sequentially numbered at the bottom.
• Research Plans are limited to twenty (20) single-sided pages, not including the Literature Cited.
Applications exceeding this page limit will not be reviewed. Include sufficient information to permit
effective review without necessitating reference to previous applications, or to the cited literature.
Information should be presented in a clear and concise manner, while being specific and informative.
• Key figures and legends must be included in the Research Plan. If uploaded as Appendices, they will
NOT be reviewed.
• If the application is a resubmission of a previously reviewed proposal, revisions should be clearly indicated
by a change in font, or bolded or underlined text. CFF will not review resubmissions that have not been
revised. Applicants will only be allowed to revise and resubmit their full application for a specific project
one time unless granted permission from the CFF Program Officer. An introduction to the revised
application, including point-by-point response to prior reviewer critiques (maximum 3 pages), should be
included using the template provided.
a. Hypothesis and Specific Aims: State concisely and realistically the intent of the proposed research
and the hypothesis to be tested. Each PI should be working together to address a single overarching
research question/hypothesis. The specific aims should test this hypothesis and be relevant to the
mission of the CFF as well as gaps in present knowledge. Do not exceed one page.
b. Background and Significance: Briefly describe the background. Critically evaluate existing knowledge
and specifically identify the gaps that the project is intended to fill, including considerations of
strengths/weaknesses or gaps in published research. Concisely state the importance and rationale of
this research by relating the specific aims to longer-term objectives. This section should show the
potential importance of the proposed work to CF.
c. Approach: Describe in detail the proposed research. This section should address the following areas,
but the order of presentation can vary to enhance readability and presentation.
d. Preliminary Results: Discuss preliminary studies, data, and/or experience of the study team pertinent
to the proposed research plan. Provide any preliminary data that supports and informs the study
hypothesis, experimental design and feasibility of the proposed aims. Information in this section
should demonstrate the study team’s expertise and ability to complete the study aims, including
attaining recruitment goals. Figures and tables should be provided when possible and sufficiently
annotated.
e. Experimental Design and Methods: Provide a detailed discussion of the experimental design and
methods to be used to accomplish the specific aims and test the stated hypothesis. Please discuss (if
applicable): primary and secondary outcome measures; study sample-inclusion and exclusion criteria;
subject enrollment including age range; sex distribution; randomization scheme; description of
experimental procedures and schedule including a study timeline; drugs and dosage; measures of
protocol compliance or treatment fidelity; follow-up schedule including a study timeline for full
project up to three years; efficacy and safety evaluation, and data monitoring and quality control. A
study timeline and schedule of events table is highly recommended.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

f. Recruitment and Retention Plan: Describe the recruitment plan for the proposed study, including
discussion of the availability of potential participants meeting inclusion and exclusion criteria for the
proposed study and anticipated yield from recruitment and screening efforts. If there is more than
one recruitment site, please provide a table showing the expected number and demographics of the
population to be recruited at each site and overall. The plan should also include a discussion of
experience in recruiting and retaining similar populations, expected challenges to recruitment and
retention, and possible contingency plans. Applicants enrolling subjects must provide a demographic
table of anticipated study participants, including race and ethnicity information, and a description of
their plans for including a diverse population including individuals historically underrepresented in
research (sex/gender, race, ethnicity, socioeconomic status, etc.). Such a plan should include
discussion of recruitment of historically underrepresented in research subjects whose primary
language is not English.
g. Statistical Analysis and Power: Clearly describe the statistical methodologies, including software, to
be used for each aim of the proposed study. Clearly describe analytic strategies for each endpoint or
outcome measure being collected. Describe any confounders or demographic variables that will be
considered during analysis. Provide discussion on how the statistical methods are appropriate for the
proposed sample size. Provide a rationale for the number of participants who will be studied. If a full
power calculation is provided, the sample size and statistical power calculations should contain
enough detail, including assumptions made, so that a reviewer can readily duplicate the sample size.
A discussion of how missing data will be handled should be included. Any planned interim analyses
should also be described.
h. Limitations and Potential Pitfalls: Discuss potential difficulties and/or limitations of the proposed
procedures and/or methods and alternative approaches to achieve aims. Describe any potential
recruitment challenges. Point out any procedures, situations or materials that may be hazardous to
personnel or patients and the precautions to be exercised.
i. Consultant Arrangements: If the proposed project includes consultant arrangements and/or
collaboration with other individuals outside the applicant’s group, describe the working relationships
and support this description with letter(s) of support signed by collaborating individual(s).
j. Literature Cited: References should be numbered in the sequence that they appear in the text and
listed at the end of the Research Plan. Each citation must include the names of authors, the name of
the journal or book, volume number, page number and year of publication (titles are optional).
Statement of Work (SOW, template available for download)
Each PI must submit an identical copy of a jointly created SOW. The contributions of each PI should be noted
for each task.
The SOW is an outline of the specific aims of the proposed research project that establishes the project
milestones during the performance period of the award. The SOW should contain sufficient detail to be
informative as a standalone document.
Protocol Synopsis, Schedule of Events, and Participant Reimbursement (template available for download,
if applicable)
Complete the information required in the available template for each aspect of the study protocol.
Provide a Schedule of Events (SOE) in a form of a table listing the study visit timelines and procedures/events
associated with each visit over the entire period of the project. Include information on which study visits must
occur in person and which may be done remotely. Provide information related to recruitment incentives or
payment for study participation for study participants, this should include proposed method and timing of
disbursement.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

Critique Response (template available for download, if applicable)
Only one Critique Response needs to be developed per team. This document should be uploaded to each full
application. Do not provide different content for each PI, as only one Critique Response upload will be
reviewed per team
For new applications: Provide a point-by-point response to the limitations noted in the critiques of the LOI,
using the template provided. Maximum three (3) pages
For resubmissions: Provide a point-by-point response to the prior reviews.
Beginning in 2018, applicant’s will only be allowed to revise and resubmit their full application for a specific
project one time unless granted permission from the CFF Program Officer. Maximum three (3) pages
Budget Justification (template available for download)
Budget Justification provided should be reflective of your individual budget request entered in your
application. Do not include justifications from other investigator’s proposals. Describe costs listed in the
Budget Detail. This document should be unique and describe the costs associated with the work for each
collaborating investigator. Use major categories, such as Salary & Benefits, Consultant Costs, Major
Equipment, etc. Justify all items and make sure amounts and figures listed in the narrative are consistent
with those listed in the Budget Detail.
Biographical Sketches for Key Personnel (template available for download)
Complete and upload an NIH Biographical Sketch for all key project personnel, beginning with the
Applicant/Principal Investigator. International applicants can upload a biosketch that is equivalent in content
to the NIH template provided. (CFF defines “key personnel” as any individual with an advanced degree that
will play an instrumental role in the accomplishment of the research project.) Do not exceed five (5) pages
per person.
Other Support (template available for download)
Complete and upload the Other Support form for all key project personnel, beginning with the
Applicant/Principal Investigator. There is no page limitation. Make sure all other support is listed not only CF
Foundation funded projects (pending, current, and previous support). Information on other support assists
CFF in the identification and resolution of potential sources of overlap. Scientific and budgetary overlap
should be minimized. Commitment of an individual’s effort greater than 100 percent, is not permitted.
Facilities Available (template available for download)
Describe the facilities and equipment available at the applicant’s institution that will be used for this project,
such as laboratory, clinical, animal, computer, office, etc. Provide any additional information about the
environment, including any support services available that will be utilized. Describe their pertinent
capabilities, proximity and anticipated extent of use. If facilities or equipment at a consultant’s or
collaborative site will be used, they should be identified and clearly described. There is no page limit. Use
continuation pages, if necessary.
Data Safety Monitoring Plan (template available for download, upload if applicable)
In compliance with Federal regulations, all applicants must submit a general description of the Data Safety
Monitoring Plan (DSMP) for any proposed study that places human subjects at more than minimal risk. A
DSMP helps to ensure subject safety, as well the validity and integrity of the data. Furthermore, a DSMP
allows for the monitoring of study data to assess whether or not an early termination is necessary for safety
or efficacy reasons.
The extent of monitoring required for a study is dependent on the level of risk involved for the subjects, as
well as the size and complexity of the study. Large, multi-center CFF-funded interventional clinical trials may
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025

be required to utilize a Data Safety and Monitoring Board (DSMB). In addition, because its members are CF
clinicians and clinical trial experts, CFF strongly encourages and may require that investigators utilize the CFF
DSMB for any other interventional CF clinical trial that meets one or more of the following criteria:
• Multi-center;
• Randomized;
• Conducted in an emergency setting;
• Use high-risk interventions, such as gene therapy, gene transfer, or bronchoscopy; or Include particularly
vulnerable study populations, such as pediatric patients.
Note: On the available template, please check whether a DSMP is required and upload the template regardless
of the response.
Address the following areas in the DSMP:
Assessment of Risk – Describe the level of risk the proposed research presents to subject participants and
provide a detailed justification for the level of risk. Discuss who will monitor the study.
Level of Risk
• Minimal Risk
Study poses no more risk than expected in daily life (blood draw, physical exam, etc.)
o
Observational studies
o
Survey or questionnaire studies
o
• Low Risk
Post-marketing study Phase IV drug or device, as defined by FDA
o
• Moderate Risk
Substantial risk (>5%) of a Serious Adverse Event (SAE) originating from the underlying condition
o
of the enrolled subject
Phase I or II study with available safety data in humans
o
• High Risk
Involves an intervention or invasive procedure with substantial risk
o
Involves the use of a new chemical or drug for which there is little or no toxicology data in
o
humans
A gene therapy study or research involving recombinant DNA or RNA molecules (gene transfer)
o
Involves vulnerable populations (pediatric, pregnant, etc.)
o
Anticipated Adverse Events and Grading Scale – Describe anticipated adverse events (AEs), including
expected frequency and the grading scale to be used. Discuss plans for addressing AEs.
Reporting of AEs – Detail the plan for reporting AEs, including who shall be notified in the event an AE
should occur.
Safety Monitoring Plan – Describe all tests, evaluations, and exclusion criteria that will be implemented
to ensure and monitor the safety of human subjects. Discuss stopping rules for the study subjects or for
the overall study if necessary.
Safety Reviews – Describe the process for monitoring and reviewing subject safety data, including the
frequency of such reviews. Include details as to who will perform the monitoring and plans for reporting.
If utilizing the CFF DSMB, provide the frequency of meetings, the reporting requirements, including AEs
and SAEs, and the procedure for interim reporting as necessary. If this information is not available at the
time of submission of the application, note that CFF will not release awarded payments until it is
provided.
CFF Multiple Principal Investigator Award Policies and Guidelines Fall 2025