National Center for Advancing Translational Sciences (NCATS) is issuing this Notice of Special Interest (NOSI) to seek UL1 Administrative Supplements to add a dedicated quality assurance/quality control position to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process.

Background

Translating biomedical discoveries into clinical applications is essential to improving human health. It is also a complex process with high costs and substantial failure rates. These failures can result in delays of years or decades before improved patient outcomes result from discoveries in biomedical research. Under NCATS leadership, the CTSA Program supports a national consortium of medical research institutions that work together to tackle system-wide scientific and operational changes that solve the many outstanding problems limiting the efficiency, effectiveness, and reach of clinical translational research, and thus get more treatments to more patients more quickly across the country. To do that, the program focuses on widely appreciated systematic barriers.

As with all NIH awards, several activities within the CTSA Program require formal NCATS Prior Approval, e.g., changes in key personnel, addition of a foreign component, and request to carryover funds. All new KL2 Scholar Projects and certain Pilot Projects that include human subjects research require formal Prior Approval, while certain new Pilot Projects that include human subjects research may require only the submission of documents and notification of NCATS prior to start. To facilitate consistency, efficiency, and enhance the submission of successful CTSA-related information packages to NCATS, this Notice seeks CTSA Program UL1 administrative supplements to support an individual to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• This administrative supplement initiative should be submitted electronically using the single component option. The single component option enables the UL1 mechanism to submit electronically. Multi-components supplements cannot be submitted electronically. Therefore, ensure to select single component when initiating the administrative supplement electronic application.

• Follow the FOA Instructions for Electronic Application Submission through the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov workspace

• Administrative Supplement Application Receipt Date(s)
  • May 4, 2020
  • September 11, 2020
  • April 5, 2021
  • September 10, 2021
  • April 4, 2022
  • September 9, 2022

• For funding consideration, applicants must include the relevant FOA information [entry format: NOT-TR-20-014 (without quotation marks)] in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.

• Eligibility
  • CTSA Program UL1 grants with more than 18-months remaining on award from the date of administrative supplement application submission.
  • New CTSA Program UL1 grants funded in FY20 or subsequent fiscal years and in response to PA-18-940 (prorated for FY20)
  • One administrative supplement award per CTSA Program UL1 grant for remaining UL1 project period (i.e., multiple year awards are allowed include a budget and budget justification for each budget period remaining in the project period)

• Requirements and Expectations
  • Budget request limited to salary, fringe, F&A for one quality assurance/quality control position
  • No less than 9 calendar months effort
  • Include a plan to describe the specific roles and responsibilities and criteria to determine success
  • Relevant qualifications for position may include but are not limited to:
    • Familiarity with Quality Assurance and Quality Control (QA/QC) and Project Management concepts; Human Subjects Research Regulations; and Institutional Processes.
    • QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services meet consumer expectations.
  • Expected activities include but are not limited to:
  • Review and improve UL1- and KL2-related administrative interactions with NCATS, e.g., Prior Approval requests, eRA Human Subjects System submissions, and submissions of other documents to NCATS
  • Oversee the process for the grantee institution
  • Obtain training from NCATS and other CTSA Consortium members and train others at the institution
  • Interact with a QA/QC group (to be created); attend quarterly virtual meetings; participate in a virtual QA/QC Discussion Forum
  • Propose improvements/innovations

  Note: Supplement project and budget periods are limited to the current and each subsequent budget period remaining in the parent project period. To be eligible, the parent award must be active (i.e., not be in an extension period), and the activities proposed in the supplement must be accomplished within the remaining active budget period that started in the current fiscal year for the existing parent award. The earliest anticipated start date is July 1, 2020. All requested budgets should be pro-rated to time remaining in the current budget period starting no earlier than July 1, 2020.

  Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

  Inquiries

  Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.