By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much is easy to understand: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are...
Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. ...
The Association of Clinical Research Professionals (ACRP) released the first of a series of white papers aimed to describe the best practices for researchers to obtain valid informed consent from participants. Members of the ACRP committee state that the current...
In December 2012, Pearl IRB published a White paper, “What Could Proposed Changes to the Common Rule Mean to Sites, Sponsors and IRBs?” The Common Rule, also known as the Federal Policy for the Protection of Human Subjects outlines regulatory requirements for human...
Recently, the International Journal of Medical Informatics published a white paper on the proceedings of the 2012 European Summit on Trustworthy Reuse of Health Data. The meeting, which convened in Brussels, Belgium in May, brought together delegates from government,...
Pearl IRB is pleased to launch it’s whitepaper entitled “Trends and Insights in IRB Warning Letters.” Learn all about IRB warning letters issued by the FDA, review the issues, and learn how to protect yourself from violations. Click here to...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?