Rapid development of technology in the medical industry is forcing life science companies and research institutions to review and modify internal procedures to adapt. Electronic informed consent (eConsent), though still highly debated, is a prominent example of a...
According to recent records published by the U.S. Food and Drug Administration (FDA), the medical industry is experiencing an alarming rise in the number of failures to follow protocol. A report produced by FDA’s Bioresearch Monitoring Program (BIMO) states that of...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?