Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)

International Council for Harmonisation. (2016). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2): Guideline for Good Clinical Practice E6(R2).

Type

Report

Intellectual base

Grey literature

Year

2016

Link

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

Cited from

computer_science

Cited by

2 citations across 2 artifacts.

Each citation links to the sentence it supports in the citing article.

Primes

• Template Instantiation
  • Sites on three continents, using different languages and different clinical customs, produce records that can be pooled precisely because the frame they filled was identical.

    This sourceDefines the case report form as the document designed to record all of the protocol-required information to be reported on each trial subject, fixing what will be recorded before any participant is enrolled.

    Supported in partVerified against the work's full text

    ICH E6(R2) requires CRFs that capture the same required data at all multicentre sites and uniform assessment standards, but does not discuss pooling records across countries.

    “5.23.2 The CRFs are designed to capture the required data at all multicentre trial sites.”

    Read by an automated reader; not a human review. How support was checked

Mechanisms

• Balance Exception Report
  • A sign-off, too, can decay into a rubber stamp when the reviewer is not truly independent.

    This sourceRequires review and approval of trial protections by an independent ethics body.

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 2 citations: 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.

Links previously used in the corpus

Before the registry existed this work was also linked 1 other way.

• https://database.ich.org/sites/default/files/E6_R2_Guideline.pdf ×1

Registry ID ref:e978ec7a470c · see in the full table