In the spring of 2018, the FDA issued updated guidance for its Clinical Trial Imaging Endpoint Process Standards. The FDA guidance focuses on imaging acquisition, display, archiving, and interpretation and recommends imaging endpoint process standards that are specific to clinical trials. Join ERT and Dr. Ford to discuss best practices to help you interpret and implement this FDA Guidance in your imaging clinical studies.
Key takeaways from this webinar:
- Learn the FDA-preferred vocabulary for all of the imaging-specific documentation needed in a regulated clinical trial.
- Engage in a discussion regarding if the FDA guidance increases or decreases the risk, cost, and/or complexity of imaging clinical trials
- Understand how risk-based monitoring and the FDA’s guidance work together