Chart 1. Roles for Electronic Medical Record Users Caring for Clinical Trial Participants and Corresponding Roles for Users Caring for “Standard Care” Patients^*.

Clinical Trail Roles	Non-Clinical Trail Roles
Principal research investigators	Standard care clinicians
Study coordinators	Clinical nurses
Study participants	Patients
Research-only clinicians	N/A
Local IRB	N/A
Research subject advocates	N/A
Funding sponsors	Third-party payers
Research institute/clinical trials office/Office of Sponsored Research	HIPAA compliance office/HIPAA Security Office
N/A	Emergency care/other clinicians
N/A	Non-clinical EMR users
N/A	Clinical administrative user
N/A	Quality improvement personnel
Research database managers	EMR technical managers
Statisticians	N/A

^*The same individual user could assume multiple roles, even for a single patient during a single encounter (mixing care scenario).