Regulatory Knowledge and Support Program Highlight
As the regulatory landscape continues to evolve and become more complex, the Regulatory Knowledge and Support (RKS) team is here to support the needs of researchers. Most recently the RKS team has attended FDA working groups to identify gaps in the regulatory sciences for in silico methods and good simulation practices. Additionally, they are assisting with navigating the regulatory pathways and institutional policies for use of Artificial Intelligence (AI) within medical records.
Furthermore, the RKS team supports researchers by providing one-on-one consults with researchers to help them prepare Investigational New Drug (IND) and Investigational Device Exemption (IDE) submission packets to the FDA, identify Institutional Review Board (IRB) pathways and development of protocols and consent forms. The RKS team also assists researchers who are awarded NCATS grants through the Kl2/K12, Pilot and Element E programs, by ensuring all regulatory documents are in order, for the NCATS prior approval submission.
The RKS Program Director, Michael Para, MD, also chairs the CCTS Data Safety Monitoring Boards (DSMBs). We are collaborating both internally and externally, to monitor the trial to ensure safety of study subjects and validity and integrity of the study data. This year started five new DSMBs, both for researchers at The Ohio State University and at Nationwide Children’s Hospital. They also started a pilot program to monitor one NIH funded clinical trial to evaluate that the study data is accurate, complete and verifiable, by actively monitoring study data source documents with the case report forms and monitoring the regulatory submissions.
The RKS team is also working cross-functionally across the university to provide tools and resources for researchers to help ensure ClinicalTrials.gov compliance. The CCTS recently purchased a ClinicalTrials.gov training course through CITI for researchers.
The RKS team is here and eager to support researchers who are navigating the complex regulatory pathways. You can reach the RKS team by emailing CCTS-Reguation@osumc.edu.