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.

National Institute of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Linked Specialized Center Cooperative Agreement (UL1)
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Rubio, Mercedes
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University of Washington
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Africa, Jonathan A; Behling, Cynthia A; Brunt, Elizabeth M et al. (2018) In Children With Nonalcoholic Fatty Liver Disease, Zone 1 Steatosis Is Associated With Advanced Fibrosis. Clin Gastroenterol Hepatol 16:438-446.e1
Simon, Tamara D; Kronman, Matthew P; Whitlock, Kathryn B et al. (2018) Reinfection after treatment of first cerebrospinal fluid shunt infection: a prospective observational cohort study. J Neurosurg Pediatr 21:346-358
Ajmera, Veeral; Belt, Patricia; Wilson, Laura A et al. (2018) Among Patients With Nonalcoholic Fatty Liver Disease, Modest Alcohol Use Is Associated With Less Improvement in Histologic Steatosis and Steatohepatitis. Clin Gastroenterol Hepatol 16:1511-1520.e5
Milgrom, Peter; Horst, Jeremy A; Ludwig, Sharity et al. (2018) Topical silver diamine fluoride for dental caries arrest in preschool children: A randomized controlled trial and microbiological analysis of caries associated microbes and resistance gene expression. J Dent 68:72-78
Cole, Allison M; Stephens, Kari A; West, Imara et al. (2018) Use of electronic health record data from diverse primary care practices to identify and characterize patients' prescribed common medications. Health Informatics J :1460458218813640
LaCourse, Sylvia M; Pavlinac, Patricia B; Cranmer, Lisa M et al. (2018) Stool Xpert MTB/RIF and urine lipoarabinomannan for the diagnosis of tuberculosis in hospitalized HIV-infected children. AIDS 32:69-78
Bhat, Amritha; Cerimele, Joseph M; Byatt, Nancy (2018) Pregnant and Postpartum Women With Bipolar Disorder: Taking the Care to Where They Are. Psychiatr Serv :appips201800133
Suskind, David L; Cohen, Stanley A; Brittnacher, Mitchell J et al. (2018) Clinical and Fecal Microbial Changes With Diet Therapy in Active Inflammatory Bowel Disease. J Clin Gastroenterol 52:155-163
Costacou, Tina; Crandell, Jamie; Kahkoska, Anna R et al. (2018) Dietary Patterns Over Time and Microalbuminuria in Youth and Young Adults With Type 1 Diabetes: The SEARCH Nutrition Ancillary Study. Diabetes Care 41:1615-1622
Vuppalanchi, Raj; Siddiqui, Mohammad S; Van Natta, Mark L et al. (2018) Performance characteristics of vibration-controlled transient elastography for evaluation of nonalcoholic fatty liver disease. Hepatology 67:134-144

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