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1 2 330 August 2017 EMA/CHMP/ICH/436221/2017 Committee for Human Medicinal Products6ICH E9 (R1) addendum on estimates and sensitivity analysis in clinical trials to the guideline on statistical principles

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What is ich e9 r1 addendum?

The ICH E9 R1 addendum is a regulatory document that provides guidance on the statistical principles for clinical trials.

Who is required to file ich e9 r1 addendum?

The sponsor of a clinical trial is required to file the ICH E9 R1 addendum.

How to fill out ich e9 r1 addendum?

The ICH E9 R1 addendum should be filled out according to the guidance provided in the document.

What is the purpose of ich e9 r1 addendum?

The purpose of the ICH E9 R1 addendum is to ensure that clinical trials are conducted in a rigorous and scientifically sound manner.

What information must be reported on ich e9 r1 addendum?

The ICH E9 R1 addendum requires the reporting of statistical methods used in the clinical trial design and analysis.

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