Innovative Technologies Working Group – Adapting Trials (In a Hurry) for Remote Assessment #2
17 April 2020: Adapting Trials (In a Hurry) for Remote Assessment Call 2
Transcript Disclaimer: the transcription was performed by a third-party service and has not been verified for accuracy by the speakers on the call. (Readers should watch the video for themselves to verify the accuracy of contents that are important to their concerns).
As a disclaimer, the FDA attendees have indicated that their comments should be considered to be personal opinions and should not be taken as official guidance. Official FDA guidance may be obtained by contacting the Clinicaltrialconduct-COVID19@fda.hhs.gov mailbox. In addition, FDA comments will be provided in a discussion format on the call and will not be provided in writing.
You may also wish to refer to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to assess whether your questions have been addressed in existing guidance.