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Recently Updated Resources

Remote and On-Site Monitoring FAQs
October 14, 2024
Remote Monitoring What is the provisioning process for a new monitor/study? The study team must submit a request for access via the Qualtrics application form. For access to HealthLink, once the...
Sponsor Monitoring and Auditing for Clinical Research Studies
October 10, 2024
Sponsor Monitoring and Auditing for Clinical Research Studies   For clinical research studies where a study sponsor is obligated by the FDA to monitor study source records, sponsors may be provided...
FDA Regulatory Affairs
September 18, 2024
FDA Affairs Located in the CTSI Office of Clinical Research, the FDA Affairs team provides FDA support and guidance for investigators submitting or holding an IND or IDE at all stages of an...

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