Time Sensitive Information: For CTSA Program Hub Applications to Meet FOA Due Dates on or after Feb. 2, 2018

CTSA Program Funding Opportunity 

Through its new CTSA Program funding opportunity announcement (FOA), PAR-18-464, NCATS is updating the forms and instructions for application submission, and incorporated modified review criteria that align with the changes in application content. On Dec. 7, 2017, NCATS issued a notice related to PAR-18-464. There are no changes to NCATS’ plans for the CTSA Program.

New Forms and Instructions

NIH regularly updates the form set used for grant applications. As announced in NOT-OD-17-062, all applicants, including CTSA Program applicants, will transition to FORMS-E for due dates on or after Feb. 2, 2018. Notably, the new form set will standardize the way applicants provide information pertinent to human subjects research and clinical trials.

The majority of form changes introduced in FORMS-E packages relate to the consolidation of human subjects and inclusion enrollment report information, previously collected across multiple forms, into a new Public Health Service (PHS) Human Subjects and Clinical Trials Information form. This new form also expands clinical trial data collection to ensure the appropriate level of information for review and to improve oversight. This new form also: 

  • Consolidates research participant, inclusion enrollment and clinical trial information;
  • Collects information on research participants and clinical trials at the study level;
  • Expands the use of discrete form fields to capture clinical trial information, which will provide the level of detail needed for peer review;
  • Leads applicants through clinical trial information collection requirements;
  • Presents key information to reviewers and agency staff in a consistent format; and
  • Aligns with ClinicalTrials.gov(where possible) and positions NIH for future data exchange with ClinicalTrials.gov.

Additional changes relate to incorporation of recent Grants.gov changes to Research & Related (R&R) Budget and Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) information forms. The Forms E application guide is available on the How to Apply - Application Guide website.

To comply with NIH best practices related to eliminating or reducing redundancy in FOAs, some application instructions that are provided in the SF424 (R&R) Application Guide have been removed from the FOA. The absence of such instructions in the body of the FOA does not reflect any change in the relative importance of the information.

Modified Review Criteria

As announced in NOT-OD-17-118, applications that include clinical trials will be evaluated using additional scored review criteria questions added to Significance, Investigator(s), Innovation, Approach, and Environment. In addition, a new stand-alone criterion, Study Timeline, has been added.

FOAs that do not accept clinical trials but permit clinical trial research experience will include additional scored review criteria questions added to existing criteria as follows:

Individual Career Development (K) Awards: Research Plan and Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Training (T) Awards: Preceptors/Mentors