Mike's Blog

Quality is not an act. It is a habit.

- Aristotle

The NCATS CTSA Program Quality Assurance / Quality Control (QA/QC) initiative was launched in FY2020 as part of the UL1 administrative supplement (NOT-TR-20-014) with a straightforward mission: help hubs deliver the highest-quality, most compliant, and least burdensome pilot award program. The idea was to reduce the administrative burden for investigators, administrators, NCATS staff, and, let’s be honest, anyone who has ever stared at a prior-approval request. 

To support this effort, the current CTSA Program NOFO continued with the same, clear expectation: 

“Include salary for one Quality Assurance / Quality Control (QA/QC) position (no less than 9 calendar months effort total; total effort may be split between two or more people) to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System (for prior approval of research with Human Subjects), submissions of proposed live vertebrate animal research for prior approval, and management of the overall quality review and submission process.” 

This dedicated QA/QC effort was never meant to be a one-size-fits-all compliance police force – it was designed to help hubs build internal research infrastructure, institutional memory, training for new investigators, and a community of practice around high-quality submissions. And, perhaps most importantly, it aimed to prevent last-minute scrambles by ensuring hubs had someone who really understood why NIH was requiring specific information and how to get it right the first time. Yet regardless of this unique method to increase efficiency, it has always been and will remain, the Federally-funded recipient organization’s responsibility to understand and adhere to NIH Policy – full stop. As reminder: 

• Grant recipients are held accountable for compliance to NIH Policy, including RPPR submissions, FFRs, drawdowns, appointment/termination forms, and Clinical Trial Reporting 
• Be prepared for potential compliance reviews and non-compliance action(s)

A Four-Year Community Effort

Beginning in November 2020, the QA/QC group convened monthly and grew into an active consortium-wide network. Across four years (FY2020–FY2024), the group held 24 meetings with well over 80 attendees per session representing UL/UM1, KL2/K12, and institutional administrative teams. These meetings tackled topics ranging from the highly technical (e.g., interpreting vertebrate animal prior-approval guidance, navigating the eRA Human Subjects System) to the universally relevant (e.g., common submission pitfalls, best practices for interoffice communication and mentoring the next generation). 

In addition to meetings, the community produced a set of practical, sustainable resources that continue to support QA/QC work, including: 

• A comprehensive shared drive containing materials from all 24 meetings (agenda, slides, examples, templates, and clarifications from NCATS) 
• A QA/QC consortium discussion forum, where staff can ask questions, compare strategies, and get feedback from both peers and NCATS experts 
• Standardized and improved workflows for prior-approval submissions involving human subjects and vertebrate animals 
• A robust FAQ resource, capturing high-frequency questions and clarifying areas where hubs commonly needed additional guidance 
• Shared examples of successful submissions, helping new QA/QC staff quickly understand expectations and learn from prior lessons 
• Documentation to support onboarding, reducing turnover-related disruption and helping new staff become productive faster 

These materials remain accessible to all hubs as living resources that can be used, adapted, and shared within local administrative teams. 

What Recent Evaluation Showed

NCATS recently completed a multi-year evaluation of the quality of prior-approval submissions during the period the QA/QC effort was active. The review looked at clarity, completeness, policy alignment, and the frequency of revisions requested.

The findings were encouraging in many ways; hubs showed increased familiarity with requirements, improved communication with NCATS, and a stronger understanding of what constitutes a complete submission. However, the data also showed: 

• A frustratingly persistent number of non-compliant submissions
• Recurrent errors in human subjects and vertebrate animal documentation
• Continued issues with RPPR submissions and unallowable copy/paste from prior years
• Ongoing challenges with ClinicalTrials.gov (CT.gov) compliance and reporting timelines
• Variation in submission quality from hub to hub

In other words, progress is real, but consistency is still a work in progress and quite a few hubs are still inadvertently keeping NCATS staff on their toes. 

Where Do We Go From Here

Based on the evaluation and the maturity of the materials developed, NCATS will be concluding the monthly QA/QC meetings. The focus will shift from large group meetings to providing technical assistance in accordance with NIH Policy as compliance needs are identified.  

NCATS will ensure:

• All previously developed resources remain available
• QA/QC personnel at hubs can continue using the forum and shared materials
• Hub-specific outreach will occur if compliance concerns are identified and technical assistance is necessary

A ‘Thank You’ for the Road

Over the past four years, the QA/QC community has done something relatively uncommon in the world of administrative compliance: it made the process collaborative, supportive, and surprisingly enjoyable. Thanks to everyone who shared examples, asked the tricky questions, and helped build resources that will outlive the meetings themselves.

In parting, and in an era that, unfortunately, may still see more belt-tightening as well as additional scrutiny, it will be the wise person who heeds the strict rules set forth by NIH grant policy. The goal moving forward is unchanged: smoother submissions, stronger compliance, fewer surprises, and ideally fewer frantic “Where is that attachment?” moments. With, hopefully, a little less caffeine required.

Let’s make 2026 the year of compliance.

Be a yardstick of quality.

Some people aren't used to an environment where excellence is expected.

- Steve Jobs