ICH E6(R2) Guideline for Good Clinical Practice¶
International Council for Harmonisation. (2016). ICH E6(R2) Guideline for Good Clinical Practice.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Journalistic Objectivity
- Clinical trials and regulatory science. Blinded outcome assessors, independent data-monitoring committees, sponsor-separated advisory panels, and pre-specified analysis plans that bind the sponsor before unblinding.
This sourceSpecifies independent data-monitoring committees functioning independently of the sponsor, blinded/independent endpoint assessment, and pre-specified analysis plans — sponsor-separating structures that convert independence into a binding constraint on trial claims.
Supported in partVerified against the work's full text
ICH E6(R2) supports independent data-monitoring committees and a protocol-stated statistical plan; blinded outcome assessors and advisory panels are not covered.
“An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.”
- Clinical trials and regulatory science. Blinded outcome assessors, independent data-monitoring committees, sponsor-separated advisory panels, and pre-specified analysis plans that bind the sponsor before unblinding.
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Read against the text for 1 of 1 citation: 1 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Registry ID ref:4b97e3a72a41 · see in the full table