Many of the advances in medical science are a result of studies that were designed based on the findings from investigator-initiated studies. Yet, there are also many problems with investigator-initiated studies from a compliance perspective, in part due to the lack of monitoring or oversight of such research. Many of the regulatory and compliance challenges confronting investigator-initiated studies are due to the variability in experience among investigators. Some investigators are seasoned researchers with experienced research teams, while others are younger researchers with little or no experience.
This webinar will provide an overview of the regulatory challenges confronting all investigator-initiated studies. Hosted by George Gasparis, a 34 year veteran in clinical research and research administration, this webinar will show you how to:
• have appropriate resources and experience on your team;
• write a research protocol that will minimize protocol deviations and protocol violations;
• determine whether your research will require an IND or IDE;
• are in compliance with FDA regulations;
• fulfill reporting requirements to the IRB and FDA;
• appropriately manage the investigational product(s) and maintain adequate drug/device records.
Please fill out the form to download our webinar "Investigator-Initiated Research Excellence".