Position papers

Where the Data Actually Travels

A companion reading from the connectivity provider seat — what routing and egress do, and do not, do to a trial’s data-protection position

More from the library

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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Who Is the Manufacturer? Economic-Operator Roles in DHT Supply Chains

How provisioning, importing, kitting and modifying a device assign manufacturer, importer and distributor duties — often by operation of law.

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You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3)

The sponsor’s duty to qualify and oversee its DHT vendors — distinct from who holds the economic-operator role.

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