With the increasing use of electronic storage of IRB documents and electronic data capture for study documentation, it is important to ensure that these uses are still in compliance with the applicable international and local regulations in the respective countries where research is conducted.

Questions

Applying the HIPAA Privacy Rule

1. From a quality assurance perspective, what would you consider to be “safe and secure” capture and storage of research data?

2. What do you think Principal Investigators have in hard copy versus in electronic format?