Clinical and Translational Science Award (CTSA) hubs, funded by the National Center for Advancing Translational Science (NCATS), aim to accelerate the translation of research into innovations that improve patient and public health. NCATS and hubs are partners in the CTSA program and rely on numerous administrative processes to ensure alignment of research priorities and compliance with federal policies. These processes become increasingly complex, leading to significant delays to study start-up and progress in the field, particularly for career development program scholars and pilot funding recipients. The most common barriers to a successful NCATS information packet submission include: incomplete or inaccurate documentation, lack of timely or clear communication between NCATS and the CTSA hub or between the CTSA hub and individual investigators submitting documentation, and lack of available training for investigators and CTSA hub staff regarding the requirements of NCATS prior approval submissions. The Institute of Translational Health Sciences (ITHS) at the University of Washington will address these issues through implementation of a Quality Information Process (QuIP), led by a Quality Assurance/Quality Control (QA/QC) Champion. This system will standardize the documentation, communications, and training process for all individuals involved in the submission of prior approval information packets. The system will be cloud-based, accessible remotely, and continuously improved using Lean methodology. The QuIP will be adaptable so that it can be iteratively changed to suit the needs of NCATS and CTSA hubs and to integrate best practices developed in collaboration with other hubs. Improving accuracy and efficiency of the prior approval process will promote faster implementation of CTSA-supported work and thus speed scientific advances to clinics and communities.

Public Health Relevance

The Institute of Translational Health Sciences (ITHS) and the National Center for Advancing Translational Science (NCATS) are dedicated to increasing the speed with which scientific advances are developed into therapies and strategies that benefit patients. This work will improve the quality and consistency of critical information communication with NCATS and will allow ITHS and NCATS to achieve their core goals faster and more efficiently.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Linked Specialized Center Cooperative Agreement (UL1)
Project #
3UL1TR002319-04S2
Application #
10155010
Study Section
Program Officer
Rubio, Mercedes
Project Start
2020-07-01
Project End
2022-02-28
Budget Start
2020-07-01
Budget End
2021-02-28
Support Year
4
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Washington
Department
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
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