Resource library
Our regulatory position papers and whitepapers on digital health technologies in clinical trials. Three download without an account; a free account opens the rest after email confirmation and personal approval, usually within one business day. No sales calls attached.
2 papers in Position papers tagged “DHT governance”
Position papers
Free
16 pages
Regulatory Impact Assessment (RIA) for Devices and Systems in Clinical Trials
Why a device’s role and triggers — not the hardware — determine whether an RIA is required
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Position papers
11 pages
Digital Health Technologies in Clinical Trials — A Regulatory Position-Paper Series
One device, several perimeters: a framework for assessing the regulatory impact of the technologies a trial relies on.
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