Can a sponsor of an FDA-regulated trial continue to monitor or audit source documents generated during the trial after the expiration date?
Yes, if the monitoring is required by or allowed under other laws. A company sponsor and its authorized representatives may continue to monitor or audit source documents so long as the time period is anticipated under the laws, even if the study has concluded. If the sponsor has a duty to monitor the source documents supporting the data submitted to the FDA under FDA regulations, HIPAA does not require an authorization.
