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.
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
Free
10 pages
The Smartphone in Digital Endpoints
Indispensable conduit, immature instrument — the phone’s role in capturing, processing and submitting digital endpoint data
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Position papers
Free
6 pages
Digital Trials and the Device Perimeter: A Regulatory Primer
A plain-language entry point to the regulatory questions raised by the devices and systems a clinical trial relies on — wearables and sensors, home and point-of-care instruments, apps and eCOA platforms, clinical systems, and the phones and tablets that connect them
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Position papers
Free
7 pages
When the Instrument Is Their Own Phone
A paper about the participant’s position on a bring-your-own-device trial — written for the sponsor, sites and vendors who must discharge the obligations that anchor to them
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Position papers
Free
6 pages
What the Trial Needs From the Handset Maker
A companion reading from the phone manufacturer / OEM (original equipment manufacturer) seat — what the trial needs from you, and why none of it is your obligation
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Position papers
Free
6 pages
Your Device, and the System It Joins
A companion reading from the wearable / biosensor manufacturer seat — your own obligations, and the system the bridge creates
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Position papers
Free
6 pages
The Sponsor’s Accountability Map
A companion reading from the sponsor’s seat — what you can delegate the work of, and what you answer for regardless
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Position papers
Free
7 pages
The eCOA / ePRO Vendor’s Hidden Obligations
A companion reading from the vendor’s seat — where your build and release choices place you inside the perimeters
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Position papers
Free
6 pages
The Provisioning Chain’s Inherited Duties
A companion reading from the logistics / provisioning vendor seat — how sourcing and configuration draw operator and end-of-life duties
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Position papers
Free
5 pages
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
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Position papers
Free
5 pages
The Control Plane Is Part of the Trust
A companion reading from the device-management vendor seat — what the control plane must evidence, and when constraining a device is someone else’s regulatory problem
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Position papers
Free
5 pages
The Update You Ship Is a Trial Event
A companion reading from the OS / firmware vendor seat — why your release is the sponsor’s change event, and what only you can tell them about it
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Position papers
Free
5 pages
The Handoff Is in Validation Scope
A companion reading from the clinical-systems vendor seat — why the integration boundary, not the device, is where the regulated record is made
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Position papers
Free
5 pages
Where the Evidence Is Actually Made
A companion reading from the CRO and site seat — which duties are yours, which are the sponsor’s, and which control belongs to neither of you
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Position papers
Free
6 pages
What an Ethics Committee Can Require
A companion reading on the ethics-committee lens — written for the sponsors, CROs and study teams who prepare the submission
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Position papers
Free
6 pages
The Inspection Lens
A companion reading on what an inspection of a digital trial actually examines — and where the evidence has to be built long before it
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Position papers
Free
8 pages
Harder Populations, Higher Bar — Paediatric and Vulnerable Participants
A cross-cutting reading of the series — the perimeters do not change, but the evidence each one demands rises, and every rise has a rule behind it
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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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Position papers
9 pages
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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Position papers
9 pages
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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Position papers
7 pages
The Trigger Register: A Controlled Instrument for Digital-Trial Compliance
Turning the per-stakeholder assessment into a living, inspection-ready artefact in the technical file, the validation plan and the TMF — grounded in the risk-based quality management GCP already expects.
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Position papers
8 pages
Change Is the Risk: Managing App, OS and Firmware Updates Across a Live Trial
A feature added in a routine update can cross a perimeter mid-study. Why change is a regulated event — and how to tell which changes are material.
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Position papers
8 pages
Predetermined Change Control Plans (PCCP) for AI/ML in Trial DHTs
Why an evolving on-device model needs a pre-agreed change plan — and why the regulatory timeline is the part most easily misjudged.
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Position papers
12 pages
Vigilance and Post-Market Surveillance for Trial DHTs
Why the reporting route turns on what the device is — and why meeting one route never discharges another.
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Position papers
9 pages
QMS Integration: Embedding DHT Controls across Sponsor and Vendor Quality Systems
Why the seam between GCP, ISO 13485 and software-lifecycle quality systems is where DHT control is won or lost.
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Position papers
10 pages
Data Residency and Cross-Border Transfer in Decentralised Trials
Where clinical data physically travels — and why the device, the connectivity layer and the controller question, not just the cloud, decide it.
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Position papers
8 pages
Designed for the Hand That Holds It: Human Factors and Use-Safety in Trial DHTs
Why usability and use-error are regulated concerns for participant-facing devices — and why the population, and the risk, set the bar.
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Position papers
9 pages
Consent on a Screen: The Regulatory Anatomy of eConsent
Why electronic informed consent sits across electronic signature, data protection and GCP / ethics — all at once — and why acceptance is not universal.
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Position papers
9 pages
The End of the Device: Decommissioning, Retention and Disposal in Digital Trials
Recovering, wiping, retaining and disposing of trial devices and the data they hold — the lifecycle stage the assessment forgets.
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Position papers
9 pages
Qualification of Digital Endpoints for Regulatory Decision-Making
Why validation produces the evidence — and qualification is the separate regulatory decision that the evidence is fit for a defined context of use.
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Position papers
10 pages
Labelling, UDI and Supply-Chain Transparency for Trial DHTs
Why the labelled article is the software, the supplied unit or the sensor — never the phone, tablet or gateway that carries it — and why BYOD makes identification harder, not exempt
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Position papers
8 pages
Risk-Based Monitoring and Device Telemetry in Decentralised Trials
Why the device is a monitorable data source — and why its telemetry belongs in the risk-based monitoring plan, not outside it
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Position papers
11 pages
Global Reconciliation: FDA, EU, PMDA, NMPA and UK Requirements for DHTs
Why the shared requirements carry across markets and the local differences do not — and how to decide when a per-jurisdiction assessment is actually needed.
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Position papers
10 pages
Continuous Monitoring, Consent and Participant Burden
Why always-on data collection reshapes consent, withdrawal and data minimisation — and why convenience is not the same as proportionality
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Position papers
9 pages
Integrating DHTs with EHRs and Clinical Systems
Why the boundary between the device and the clinical system is the regulated unit — and why provenance must survive the handoff
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Position papers
8 pages
Diversity, Representativeness and Equitable Access in DHT Deployment
Why who a device can reach is a data-validity question — and why the durable regulatory anchor is the representativeness of the enrolled population.
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Position papers
7 pages
Sensor-Based DHTs Cleared by FDA: A Landscape Annex
A structured view of the sensor-based digital health technologies FDA has authorised — what they measure, who makes them, how they connect, and what the list does not tell a sponsor
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Position papers
10 pages
Validating Sensor-Derived Endpoints in Clinical Trials
Why a sensor reading is only as good as its verification, analytical, clinical and usability validation — and the interpretation threshold that makes it an endpoint.
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Position papers
9 pages
When the Device Thinks: AI/ML in Trial DHTs and the Stacking of Obligations
How an on-device model adds an AI overlay on top of the device rules — and why the 2028 application date is a trap, not a reprieve.
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Position papers
9 pages
Securing the Trial Device: Cybersecurity Obligations for Clinical DHTs
A networked device holding clinical data is a security artefact — and security is a data-integrity obligation, not optional hygiene.
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Position papers
9 pages
Inspection-Ready: What FDA, EU and MHRA Inspectors Look For in DHT Evidence
In qointa’s experience the first inspection sets the baseline. What digital-trial evidence inspectors expect, what it is grounded in — and why it must exist before they ask.
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Position papers
8 pages
ALCOA+ on the Device: Device-Side Data Integrity in GCP
When a device captures trial data — a handset, a wearable, a home instrument or the gateway that relays them — attribution, time and protection against alteration are decided on the device, and no validated database can decide them later.
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Position papers
9 pages
When the Phone or Gateway Is the Hub: Interoperability and Connected-Device Systems
When a hub — the participant’s phone, a tablet or a provisioned cellular gateway — bridges a sensor, wearable, spirometer or CGM, the combined system, and the device-to-device boundary, becomes the regulatory unit.
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