In recent years, along side the increase in patient involvement in the design and conduct of research programs, there has been a notable increase in the idea of “virtual” or “decentralized” clinical trials. In the virtual trial model, clinical studies are focused on bringing the clinical study directly to the participant and allowing data collection to be completed in a participant’s home or local community. This paper examines the nature of virtual clinical trials, potential benefits and risks of this new paradigm, and best practices for maintaining regulatory and Institutional Review Board (IRB) compliance.
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In 2018 WIRB approved 100% of the single-patient EA requests that were submitted for review.
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago. Since then, the IRB developed a well-organized process for its partnerships with independent IRBs.
On January 21, 2019, most federally funded research will need to follow the 2018 Requirements of the Common Rule. This post talks through the original and revised rules, and how they may apply to you.
Daniel Kavanagh, PhD, responds to recent news of germline editing of human embryos in China.
Studies show clinical trial participants want to know what was learned from their involvement. Many sponsors are implementing plans to deliver plain language summaries to trial participants.
Often, the only way for potential research subjects to learn about a clinical trial is through recruitment materials. But what materials must you submit to the IRB for review?
