Kyle Faget Publishes on FDA Guidance for Investigator Responsibilities in Decentralized Clinical Trials

Foley & Lardner LLP partner Kyle Faget authored the Clinical Leader article, “What The FDA Says About Investigator Responsibilities in DCTs,” examining the U.S. Food and Drug Administration’s September 2024 guidance on conducting decentralized clinical trials (DCTs) for drugs, biological products, and medical devices.

The guidance outlines investigator oversight obligations when trial activities occur outside traditional clinical sites, including the appropriate use of local health care providers for protocol‑permitted tasks, compliance with investigational plans and regulations, and quality review of data collected in community settings. Faget details best practices for delegating activities, communicating protocol instructions to minimize variability, and ensuring adequate supervision — including the use of videoconferencing to oversee remote activities.

Faget also addresses use of telemedicine in DCTs, highlighting that investigators must comply with varied state laws governing licensure and practice standards when clinical trial procedures intersect with the practice of medicine. She explains relevant licensure pathways, exceptions (such as border state and follow‑up care rules), and telemedicine requirements like informed consent, patient identification, and modality standards for establishing and maintaining practitioner‑patient relationships.