Ensuring consistency, efficiency, and quality
Our CTSA Hub has been awarded an administrative supplement to add a dedicated quality assurance/quality control position that will perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall process. Ellen Divoky is an accomplished regulatory and compliance expert and will provide oversight for quality assurance and quality control for our CTSC to include all partner institutions. Ms. Divoky has vast experience with the IRB, FDA and other regulatory related areas.
As with all NIH awards, several activities within the CTSA Program require formal Prior Approval for human subjects and vertebrate animal research, e.g., changes in key personnel, inclusion of a foreign component, or request to carryover funds. All new KL2 Scholar Projects and most Pilot Projects require formal Prior Approval, while certain human subject Pilot Projects may require only the submission of documents to NCATS prior to start.
With an emphasis on ensuring consistency and efficiency to ensure the acceleration of research, Ellen will:
- Perform quality assurance review of CTSA pilot and KL2 research project submissions to NCATS through the eRA ASSIST Human Subjects System and management of the overall process
- Provide training to investigators and administrators to improve the NCATS submission process for delayed onset, IACUC, and other compliance related documents
- Provide advice on regulatory compliance for studies, IRB submissions, FDA guidance
- Ensure that publications meet NIH compliance requirements and have cited the CTSA award
- Positively impact our hub’s interactions with NCATS and further streamline translational research by submitting error free documents
- Participate in the QA/QC Workgroup within the CTSA Consortium and other activities organized by NCATS under this program