In the spring of 2018, the FDA issued updated guidance for its Clinical Trial Imaging Endpoint Process Standards. The FDA guidance focuses on image acquisition, display, archiving, and interpretation, and recommends imaging endpoint process standards that are specific to clinical trials. Furthermore, the FDA recommends developing an imaging charter to standardize imaging procedures among the clinical trial key stakeholders, such as imaging acquisition, image interpretation, and imaging data management.
Join ERT and Dr. Ford to discuss these updated best practices to help you improve the creation of your next clinical trial imaging charter.
Key takeaways from this webinar:
- Learn best practices for drafting high quality, compliant imaging charter
- Understand how to submit and defend an imaging charter with respect to the FDA
- Discuss if the FDA guidance increases or decreases the risk, cost, and/or complexity of imaging clinical trials