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

1 citation across 1 artifact.

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.

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:e978ec7a470c · see in the full table