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.
- HIPAA Security Rule
- 21 CFR Part 11