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CTSI Internal Funding Help and FAQs

The CTSI offers several funding opportunities that each releases its own FOA.  The information about these opportunities can be found on this page: https://ctsi.utah.edu/cores-and-services/more-resources/internal-funding-opportunities

The CTSI is funded by the National Center for Advancing Translational Sciences (NCATS), an NIH Center, which offers a variety of funding opportunities.  Projects funded through the CTSI must meet all NIH requirements. 

CTSI proposals receive two formal reviews: internal to the University and external by NCATS. CTSI highest scoring proposals receive an intent-to-fund or just-in-time letter which explains the information and documents required for the NCATS review. The review by NCATS is called the “Prior Approval” (PA) process. 

To answer questions about these opportunities, please refer to the FAQs below.  In addition, there are CTSI staff available to assist you through this process—their contact information is provided below.

  • What are some Best Practices for writing the Research Design and Methods Section of the application?
    • How many primary endpoints and secondary endpoints should my proposal have?
    • Clinical studies/trials should have only one primary endpoint and no more than five (5) secondary endpoints. This structure will align with Outcome Measures in clinicaltrials.gov.
      • Too many endpoints create a data weed field, which is one factor that inhibits manuscript writing.  If a study/trial is completed with no tangible/reportable results, this has wasted the participants’ time in providing their information for a study/trial.  This type of issue is a social justice issue https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
    • START WITH THE END IN MIND: After creating your study/trial concept or hypothesis, ask yourself, “What journal article can I envision writing when this study/trial is completed – what data points and data elements will this article need?”  These answers will be the basis for writing a Data Management Plan (DMP).
      • The purpose of a DMP is to ensure the data being collected for the study/trial will yield the appropriate data output for the statistical analysis plan and publication goals.
      • A DMP is a written document that outlines the data expected to be collected throughout the course of the study/trial. The DMP will describe study/trial parameters, including required data points to be recorded in the Case Report Forms, location of data, proposed time points for export and analysis, and personnel responsibilities for data-related tasks. These quality control processes will ensure discrepancies are corrected or otherwise addressed prior to analyzing the data.

     

    • WRITE THIS SECTION THROUGH THE EYES OF A STUDY COORDINATOR
      • With an Industry-sponsored (pharma) trial, the Protocol is in essence a Manual of Operations for the Principal Investigator (PI) and study coordinator (SC).  However, NIH grant applications with a human subject research project often lack the vital Protocol elements that make life much easier for the SC.  A grant proposal is not a protocol. 
      • An experienced SC is a valuable collaborator to assist the PI in writing the ‘how-to’ sections of the Research Design and Methods Section.  At the very least, the SC should be asked to review this section to ensure it is clear enough that they can follow every step without any questions.
      • Vital elements that help the SC fulfill their role are:
        • Study Calendar or Schedule of Activities
        • Study schema and flow diagram
        • Clear eligibility criteria
        • Clear and detailed description of ALL tests/interventions
      • An unclear Research Design and Methods Section leaves the SC guessing what to do, and guessing always increases the risk for error, deviations, and non-compliance. 

     

  • How do I know if my project is considered a clinical trial by the NIH?

    *The NIH definition of a clinical trial can include minimal risk studies, therefore, even if your IRB determination letter states “minimal risk” it can meet the NIH definition of a clinical trial. 

    Answer the following questions YES or NO.  See these NIH webpages for assistance – https://grants.nih.gov/policy/clinical-trials/definition.htm and https://grants.nih.gov/ct-decision/index.htm

    1. Does the study involve human participants?

     

    1. Are the participants prospectively assigned to an intervention?
      1. An "intervention" is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

     

    1. Is the study designed to evaluate the effect of the intervention on the participants?

     

    1. Is the effect being evaluated a health-related biomedical or behavioral outcome?
      1. A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.

     

    If you answered ‘Yes’ to all these questions, your study meets the NIH definition of a clinical trial and, therefore, must meet all NIH requirement for clinical trials.  

  • How do I meet the NIH requirement for compliance with the NIH Public Access Policy?
    • Publications resulting as a direct result of support from the CTSI are required to be submitted to PubMed Central to comply with the NIH Public Access Policy (https://publicaccess.nih.gov/).
    • Please note, simply publishing an article as “open access” does not meet the NIH Public Access Policy.
    • Any of the authors (or a delegate) can submit the manuscript to PubMed Central through NIHMS. To upload a manuscript, the NIHMS system can be accessed either through the publication in MyBibliography in NCBI (link to instructions) or here - https://www.nihms.nih.gov/submission/. The system requires a login, which can be your eRA Commons account.
    • The NIHMS system allows for entering the PubMed ID number to populate most of the information. The system asks you to upload the final peer-reviewed manuscript as most publishers have copyrights to the published article. You can upload any tables, figures, and supplement documents if they are separate from the manuscript. The system will ask you to link the article to the funding grant. For the CTSI grant numbers and more information about citing the CTSI in your publications, please see this webpage - https://ctsi.utah.edu/administration/citing