The NCATS Human Subjects Research (HSR) Prior Approval (PA) process for KL2 Scholar Projects and certain Pilot Projects has been challenging for CTSA institutions to navigate. The Indiana CTSI will create a dedicated Quality Assurance/Quality Control (QA/QC) Project Manager role to improve quality and facilitate the HSRPA process. The long-term goal is to improve the quality of human subjects research submissions, make the overall process more efficient, and provide quality assurance for the ongoing conduct of research at the Indiana CTSI, with a particular emphasis on young investigators. The objectives are to decrease the review timeline from the time of award to study startup by supporting the education of young investigators and to ensure research conducted is at the highest quality so that important clinical research discoveries can positively impact patient outcomes more quickly.
The specific aims are to: (1) Create a dedicated QA/QC position within the Indiana CTSI to perform quality reviews of CTSA-related submissions to NCATS, submit to the HSS, and manage the overall process; (2) Support applications by interfacing with KL2 Scholars and Pilot Project awardees throughout the IRB submission process; (3) Monitor funded projects once approved to ensure data quality and compliance; and (4) Offer QA/QC support to other K-funded young investigators. Accomplishing the above aims will enable measurable improvements in all stages of the HSRPA process and study conduct for KL2 Scholar Projects and certain Pilot Projects. In particular, individualized support to young investigators throughout their project will greatly enhance their training and preparation for a productive career in clinical research.

Public Health Relevance

It is essential that the next generation of researchers have the ability to navigate complex policies and regulations. This project will provide hands-on guidance for federal and local policy and regulatory requirements to early-career researchers and other researchers who receive certain NIH funding. It will also support researchers by ensuring that their research is conducted according to the highest quality standards.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Linked Specialized Center Cooperative Agreement (UL1)
Project #
3UL1TR002529-03S1
Application #
10157125
Study Section
Program Officer
Davis Nagel, Joan
Project Start
2020-07-01
Project End
2023-04-30
Budget Start
2020-07-01
Budget End
2021-04-30
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Psychiatry
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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