Primer on FDA’s Final DHT Guidance

Remote data acquisition is becoming an increasingly common tool within clinical research. The FDA recently issued final guidance on use of DHTs for this type of data collection. Read this overview to learn their recommendations.

Design and related technological characteristics of the DHT
Data output provided to the sponsor and investigator
How the DHT measures the clinical event or characteristic of interest
The flow of data from the DHT to the first durable electronic data repository
Features that impact usability
How access to the DHT or the data collected from it is controlled to ensure privacy and security including methods for access control
Data management, including collection, storage, transmission, and archiving in the submission


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