Confidentiality and privacy rules for protection of human subjects at research sites are determined by...

The confidentiality and privacy rules protecting human subjects in clinical research are established by applicable regulatory authorities, such as the FDA or EMA, and must be followed by all research sites. These regulations ensure that participants' personal data are handled securely and ethically.

GCP guidelines mandate compliance with local, national, and international regulations regarding data confidentiality and privacy.

"Confidentiality and privacy protections are determined by applicable regulatory authorities and must be adhered to by all study sites."

Objectives:

Protect participant privacy.

Ensure compliance with data protection regulations.