Talk:Good clinical practice

Needs work!
I am too busy tonight but I think this article definitely needs a big overhaul. The purpose of a WP article is first and foremost to explain what the subject of the article is".--MarmotteiNoZ 06:54, 24 July 2014 (UTC)

Does it cover statistics
Does GCP specify that clinical trial protocols should specify the outcomes and statistical analysis to be performed ?


 * THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE EFFICACY – M4E(R1) CLINICAL OVERVIEW AND CLINICAL SUMMARY OF MODULE 2 MODULE 5 : CLINICAL STUDY REPORTS seems to, but without prescribing the statistical tests themselves.

What regulation or guideline specifies that clinical trial reports use a 5% significance level ? - Rod57 (talk) 02:58, 11 February 2012 (UTC)