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
REGULATORY OPERATIONSYou can transfer every activity in a digital trial. You cannot transfer the answer you give at inspection.
ICH E6(R3) puts ultimate responsibility for the reliability of trial data with the sponsor, whoever performs the work — so the perimeters are one map of obligations you own across every device maker, vendor, CRO and site. Treat "no obligation" as a conclusion you can produce, not an assumption from the hardware label.
Every perimeter is delegable work wrapped in accountability you keep
| Perimeter / topic | Sponsor action / evidence | Series paper |
|---|---|---|
| Assess vs assume | Complete and date a Regulatory Impact Assessment before controls are fixed | QPP-00 |
| Endpoints / data | Hold V3 evidence plus a data-residency and integrity record | QPP-01, QPP-02, QPP-10 |
| Operator roles, AI and security | Record who is manufacturer, importer, distributor or pack producer; record AI and security controls and owners | QPP-03, QPP-04, QPP-05 |
| Inspection / change | Keep device-side evidence; bring updates under change control | QPP-06, QPP-07 |
| Consent, human factors, decommissioning | Evidence valid eConsent, human-factors work and a decommissioning plan | QPP-09, QPP-11, QPP-13 |
| Oversight / record | Qualify and oversee vendors; maintain a current trigger register | QPP-08, QPP-12 |
Four propositions decide how a device question ends at inspection
You answer for the data at inspection, whoever built, provisioned and ran the device — ICH E6(R3)'s "ultimate responsibility".
It comes from an assessment you can show, not the hardware label. FDA (BIMO), the EU national competent authorities and the MHRA ask what you assessed, when, and on what basis.
A consumer handset, a CE-marked wearable, a home instrument on a cellular gateway and an eCOA app each raise a different question. One party's assessment does not discharge yours.
A dated, owned assessment converts a belief about the device into evidence an inspector can test. A vendor's certification describes the vendor; oversight is your own activity.
Four actions: resolve the device questions once, up front, in a record you control
- 1Run the RIA before fixing controls so every "no obligation" is a recorded, dated conclusion, not an assumption.
- 2Own oversight as your own activity so a vendor's certification never stands in for your evidence; validating the systems you use stays yours.
- 3Maintain a live Trigger Register so a model, routing or scope change reopens the right assessment, not an inspection finding.
- 4Assign internal owners so accountability is held jointly across QA / GCP, regulatory affairs and CSV — "the sponsor" is not a single desk.
ICH E6(R3) · FDA (BIMO) inspection · EU national competent authorities · MHRA
© qointa 2026 – Public – Uncontrolled when printed · Not legal advice; this summary does not classify any device.
sales@qointa.com · qointa.com
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Read more →Talk to a specialist
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