Records de pacientes
Paper-based records stored in a secured location | Yes |
Secure, password protected, HIPAA and Part 11 compliant computer-based files are used | Yes |
Prior to access of PHI, site personnel and any visitors sign confidentiality statements agreeing to protect PHI | Yes |
PHI identifiers are removed/obliterated from study-related information | Yes |
Personnel receive documented HIPAA training | Yes |
Research patients are notified of the HIPAA rights prior to any procedures being performed | Yes |