Cystic Fibrosis Foundation Statistical Expertise and Network Award

Eligibility

Applications will be accepted from individuals at domestic academic institutions that are CF accredited Therapeutic Development Centers (TDCs). United States residents and applicants from outside the United States are welcome to apply. Note: Students are not supported by this program.

Summary

This award will promote greater collaborative integration of statisticians and CF clinical investigators at TDN institutions by funding local statisticians and integrating them into the CF Statistical Research Network (CF StatNet). Dedicated statistical expertise is increasingly important to conducting rigorous clinical research in CF. Most clinical investigators, regardless of experience level, lack adequate training to conduct studies without the assistance of a dedicated biostatistician to assist with the design, implementation, and analysis of results. 

This program is intended to attract existing statisticians into the local CF research communities by providing funded effort specific to CF clinical research at those sites. This activity may include analyses of existing data, assisting in the preparation of applications, designing and assisting with the conduction of prospective clinical studies, or data analysis and publication of new results. Applications are encouraged from either CF clinical investigators who identify a faculty or staff statistician at their home institution or faculty statisticians who already have an existing relationship with the local CF Therapeutics Development Center (TDC). 

The biostatistical faculty and staff at the CF Foundation’s TDN Coordinating Center (TDNCC) will engage recipients of this award to develop and expand the academic community of likeminded biostatistical researchers across the United States. This will include an annual CF biostatistics and epidemiology meeting in Seattle, Washington, dedicated meetings during the North American Cystic Fibrosis Conference (NACFC), and monthly webinars to share works-in-progress and research methods specific to biostatistics, study design, and outcomes in CF. This broader integration will help to develop a national network of experts capable of more effectively meeting the statistical needs in CF clinical research. This group will be poised to establish consensus and innovate methods applicable to a variety of CF clinical research outcomes in the years ahead.

Goals of Research 

The following research areas are of particular interest to the CF Foundation as they will address critical needs of people with CF: 

• Studies that investigate CF disease complications (lung, GI tract, liver, pancreas, reproduction, mental health, endocrine etc.) 
• Strategies to improve care and quality of life of people with CF 
• Assessment and validation of biomarkers, clinical trial tools, outcome measures and efficacy endpoints 
• Translational or clinical studies in lung transplant research 
• Characterization of CF disease manifestations and management in the era of highly effective modulator therapy 
• Novel interventions that improve CF patient care and outcomes 
• Studies designed to translate laboratory findings of disease pathogenesis/treatment to clinical evaluation 
• Studies that identify and characterize racial, ethnic, and/or societal contributors to CF disease expression and management

Funding Amount 

This program provides salary support for the named statistician-awardee in a tapered structure in addition to travel for meetings. Indirect costs are not allowed on this award. Students are not supported on this award. 

• Year 1 funding is at a maximum of 35% FTE 
• Year 2 funding is at a maximum of 25% FTE 
• Year 3 funding is at a maximum of 20% FTE 

The award will cover standard institutional fringe benefits for that salary. In accordance with NIH policy, salary requests may not use an institutional base salary in excess of the current federal salary cap of $221,900. Salaries may be supplemented by the applicant institution. 

This program provides optional salary support for the non-statistician Principal Investigator (PI) from 1% up to a maximum of 5% FTE each year. Regardless of salary support requested, the PI is expected to regularly interact with the statistician-awardee in an effort to fully integrate her or him into the local CF research community and transition to additional external grant support during the award. PIs requesting salary support are expected to attend the majority of monthly conference calls, individually meet with the statistician-awardee regularly to review active projects, and work to ensure local faculty support. They are not expected to attend the in-person meetings in Seattle, WA.

Overhead

Not allowable as per sponsor policy. 

Pre-application deadlines

RSO internal deadline

Pre-application program deadline

Application deadlines

RSO detailed review deadline

RSO final internal review deadline

Program application deadline

NOTE: Consult your Faculty Associate Dean (Research) (ADR) regarding Faculty-specific deadlines and submission processes.

Principal Investigators: Complete a Research Management System (RMS) record, including a copy of your complete application, and submit this for approvals in RMS.

Postdocs, students, and trainees: For fellowships and externally-sponsored research training awards or opportunities, you must complete the Research Funding Application Approval (RFAA) Trainee PDF form, and submit it, along with a complete copy of the application, to Research Services at rsotrainee@ucalgary.ca. Trainees should not use RMS at this time.

Approvals: The University of Calgary requires that all funding applications be approved prior to submission. Approval requires signatures via either RMS or the RFAA Trainee form, in the following order:

• Principal Investigator
• Department Head
• Faculty ADR/Dean
• Research Services (on behalf of the Vice-President Research)

Read the Meaning of Grant Signatures policy to understand what your approval means. Please see the agency guidelines for details about which signatures are required on your application, as it may differ from internal requirements.

Late submissions: Late submissions will only be accepted in cases of medical or family emergencies, or other exceptional circumstances. If you submit your RMS record to Research Services after the internal deadline has passed, you must secure additional approvals. Please read: Late Applications Process.

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. 

General Timeline: 

LOI Submission Deadline* August 28, 2024 
LOI Applicant Notified Early October, 2024 
Full Application Deadline December 6, 2024 
Committee Review Date January 2025 
Notification to Applicants February 2025 
Project Start Date March 1, 2025 

*We highly 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 Team is able to assist all applicant with any potential system-related queries prior to the Application Deadline.

ADDITIONAL RESOURCES

Support for projects involving Indigenous Research:

Support with the development of your grant application is available internally through the Indigenous Research Support Team (IRST). Applicants can reach out by email to IRST at IRST@ucalgary.ca in advance of the RSO internal deadline. For more information about IRST, please visit the IRST webpage.

Support for Knowledge Engagement:

Support for knowledge mobilization/engagement/translation is available internally through the Knowledge Engagement Team. Applicants can reach out by email to the KE team at knowledge.engagement@ucalgary.ca in advance of the RSO internal deadline. For more information, please visit the KE team webpage.

Support for Research Data Management:

For information on research data management plans, processes, or best practices for your research program, please contact research.data@libanswers.ucalgary.com and/or visit https://libguides.ucalgary.ca/researchdatamanagement.

Support for EDI in Research:

RSO can provide resources and support to research teams on the integration of equitable and inclusive practices in research design and research practice. Contact Erin.OToole@ucalgary.ca for more information.

RMS: Creating a Pre-Award LOI

RMS: Creating a Pre-Award Application