FDA released yesterday this FINAL guidance on "Conducting Clinical Trials With Decentralized Elements"
The Introduction notes some scope aspects of decentralized trials:
"Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers (HCPs) (see sections II and III.B). In this guidance, a decentralized clinical trial (DCT) refers to a clinical trial that includes decentralized elements where trial-related activities occur at locations other than traditional clinical trial sites."
And some expectations are unchanged from traditional trials:
"FDA's regulatory requirements for investigations of medical products are the same for trials that include decentralized elements and trials that do not include decentralized elements."
#fda #DecentralizedTrials
https://www.fda.gov/media/167696/download
------------------------------
Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
------------------------------
</bioanalysisandbiomarkers.blogspot.com>