Methodology

Scores, evidence levels and the D1–D6 pathway

This module describes methodological capability and review priorities. It never validates a protocol, a claim or a product.

Scientific substantiability score /100

Components: measurement maturity /25, endpoint directness /25, wording specificity /20, repeatability /15, transferability /15. Scores are expert judgements that have not been calibrated by a validation study, and no score in the catalogue is marked high confidence.

Regulatory screening risk /100

Components: classification /40, pathway burden /25, wording /20 (wording uplift capped at 20), jurisdiction uncertainty /15, total capped at 100. Bands: Lower 0–24, Moderate 25–49, High 50–74, Critical 75–100. A low score is not an authorisation and mandatory classification or procedure checks always remain.

Research cut-off 2026-09-10. Publication date, consultation date and application date are distinct.

Target evidence levels E1–E6

These are target levels proposed by the catalogue. An achieved level exists only in a product dossier assessment and is never derived from the scientific score.

Evaluation pathway D1–D6

Where are you in the pathway?

A short orientation questionnaire. The result is methodological guidance you can explain — never an automatic validation of a protocol or a claim.

Is the exact claim wording, product and target market list already fixed?
Have you mapped the evidence you already hold against that wording?
Have you run exploratory or pilot testing on the endpoint?
Do you have a confirmatory study with a pre-defined analysis plan?
Has the evidence been independently challenged and translated into wording?
Is a release and lifecycle monitoring process in place?

Suggested focus: D1