- Version
- 1.0
- Length
- 11 pages
Abstract
Assess the devices and systems a trial relies on before the protocol is fixed, and record the result. In digital health technology (DHT) trials, the regulatory problems that cost most are, in qointa’s experience, the ones found last. A wearable, a home instrument, a tablet, a phone or an app is waved through as ordinary hardware while a study is being designed — and the obligations it was actually carrying surface only at submission, at inspection, or when a field-safety issue exposes a role nobody had assigned. By then the remedy is retrospective validation, protocol amendments, or data that cannot be used. The cause is a single, correctable misconception. A device’s regulatory status follows its function, not its form factor — and because function is what the frameworks read, one device can fall inside several regulated perimeters at the same time. Those obligations stack; meeting one does not discharge another. “No obligation” is a conclusion that can only be reached by assessing — never a starting assumption. The series is built on one organizing image: one device, several perimeters. It works through the seven perimeters a trial device or system can occupy — medical-device, GxP and computerized-systems, data-protection, human-factors, configuration, economic-operator and protocol-design — and shows how to assess each, per stakeholder and per study setup, instead of guessing. The obligations are read from what the device does in the protocol and from who controls it — provisioned by the sponsor or brought by the participant — not from the label on the box. And because the device that measures is often not the device that transmits, the phone or tablet that carries another device’s data is assessed in its own right (QPP-C). What the series gives you. Twenty-five numbered papers (Papers 0 to 24), each anchored to one perimeter and to a decision a reader actually faces, plus fourteen Stakeholder Editions (S01–S14) and a plain-language Primer that read the same material for one party at a time. Two of the papers hold the rest together: QPP-00 — Regulatory Impact Assessment (RIA) is the entry point, and QPP-08 — Trigger Register is the controlled record that keeps the decision current as the study changes. What to do first. Inventory every device, app and system the trial relies on; run the RIA on each; record the controls decision, its owner and its reasoning in the Trigger Register; and re-run the assessment whenever a trigger fires. Section 7 sets out the loop.
Contents
1. The obligations surface late, and that is what makes them expensive; 2. Four principles decide every case in this series; 3. Twenty-five papers, each answering one decision a reader faces; 4. One device, seven perimeters — and the obligations stack; 5. QPP-00 opens the series; QPP-08 holds it together; 6. Assessing early costs less than remediating late; 7. Two artifacts run the series: the RIA and the Trigger Register; 8. The obligations land differently on every party in the chain
The full paper is free with a qointa account — one account opens every paper in the library. We do not attach a sales call to a download.