Yale Clinical and Translational Science Award: Integrated Enterprise Level Feasibility, Activation, Risk Management, Quality Assurance and Improvement

NIH RePORTER · NIH · UL1 · $37,755 · view on reporter.nih.gov ↗

Abstract

Abstract To facilitate clinical trial consistency and efficiency, and to enhance the submission of successful CTSA-related NCATS Prior Approval information packages, the Yale CTSA hub is applying 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. The funding will enable dedicated support and will expand the current YCCI Quality Assurance team to include the following: the review and improvement of 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 CTSA Hub; institutional training from NCATS and other CTSA Consortium members and the training of others at the Yale CTSA Hub; and interactions with a QA/QC group, including attendance at quarterly virtual meetings and participation in a virtual QA/QC Discussion Forum. With this application the Yale CTSA Hub is also proposing improvements/innovations which could potentially aid other CTSA Hubs.

Key facts

NIH application ID
10485570
Project number
3UL1TR001863-06S1
Recipient
YALE UNIVERSITY
Principal Investigator
John H. Krystal
Activity code
UL1
Funding institute
NIH
Fiscal year
2022
Award amount
$37,755
Award type
3
Project period
2022-03-30 → 2026-05-31