By James Riddle, MCSE, CIP, CPIA, CRQM, VP of Research Services & Strategic Consulting
In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site.
Ethical oversight committees (like Advarra’s institutional review board [IRB]) continue to innovate to keep pace with the rapid changes and evolution of research conduct. Study designs flexibly incorporating telepresence visits, remote home visits, and other decentralized clinical trial technologies and innovations provide improved participant engagement.
IRBs must become familiar with this technology in order to appropriately consider how such innovations impact the participant experience and a given study’s risk/benefit assessment. It’s also important for IRBs to understand how their review requirements can impact overall study efficiencies.
This blog highlights how IRBs can simplify review of electronic patient reported outcome (ePRO) and electronic clinical outcome assessment (eCOA) materials to streamline study startup without impacting the review quality.