One of the CITI recommendations for decentralized clinical trials is around understanding and managing complex local laws and regulations. The following methods could be utilized to keep abreast with the latest updates:

Use of policy organization resource centers:

Sponsors should consider using online resources of policy organizations that specialize in telemedicine laws. Several state and national telemedicine resource centers exist that publish applicable state telemedicine laws online.

Reliable legal expertise is recommended to track state licensing laws. Due to the many changes occurring regularly in individual states’ telemedicine laws, ongoing review of licensing laws is necessary.

To ease the burden on the sponsor’s legal staffing, alternative solutions may be necessary, such as seeking external legal consultants and/or partnerships or subscriptions to companies that track and report state-by-state changes in laws and regulations.

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