Issue Date: December 22, 2023
Issued by: Oncology Center of Excellence
Topic(s): Clinical – Medical
Status: Final
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient. Additional Guidance Resources: DHT for Remote Data Acquisition in Clinical Investigations: Guidance Snapshot DHT for Remote Data Acquisition in Clinical Investigations: Guidance Recap Podcast DHT for Remote Data Acquisition in Clinical Investigations: Guidance Recap Podcast Transcript
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