At a close-out visit, which document should be retained only at the site?

The subject identification code list, which links the participant’s unique code to their personal information, must be retained only at the site. This list ensures confidentiality and is necessary for identifying participants during follow-up. It is not shared with the sponsor to protect participant privacy.

GCP guidelines mandate that the subject identification code list remains at the site to ensure confidentiality and compliance with data protection regulations.

"The subject identification code list must be securely stored at the site to maintain participant confidentiality."

Objectives:

Safeguard participant confidentiality.

Maintain compliance with data protection policies.