White Paper

The Convergence Of GDPR, The HIPAA Security Rule, And Part 11 On US Clinical Research

Source: Quorum Review IRB

By Mitchell Parrish, JD, RAC, CIP, VP of Legal Affairs; James Riddle, MCSE, CIP, CPIA, VP of Client Services; Dominic Chiarelli, JD, CIP, Manager of Legal Affairs; and Michelle Grienauer, JD, MPH, CIP, Senior Consultant

scientists lab technology digital tablet data

Clinical research now has electronic “e” everything - eRecords, eRegulatory Binders, eTrial Master Files, eConsent, ePatient-Report Outcomes, eClinical Outcome Assessments, eClinical Trial Management Systems, and more. Due to the sensitive nature of the personal information collected, and the importance of accurate data in medical product development, new pertinent regulations governing electronic information have passed and older regulations (some very old) are being reapplied in new ways. This paper examines three of those major regulations and their impacts on clinical research in the US.