ICH E6(R2) Guideline for Good Clinical Practice

International Council for Harmonisation. (2016). ICH E6(R2) Guideline for Good Clinical Practice.

Type

Report

Intellectual base

Grey literature

Year

2016

Link

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

Cited from

philosophy

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.

Verification

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Registry ID ref:4b97e3a72a41 · see in the full table