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Get Ich E9 (r1) Addendum On Estimands And Sensitivity
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How to fill out the ICH E9 (R1) Addendum on Estimands and Sensitivity online
The ICH E9 (R1) addendum provides crucial guidelines for defining estimands and conducting sensitivity analyses in clinical trials. This guide serves to assist users in understanding how to fill out the document online, ensuring clarity and accuracy throughout the process.
Follow the steps to complete the ICH E9 (R1) Addendum online.
- Press the ‘Get Form’ button to access the ICH E9 (R1) addendum and open it in your document editor.
- Carefully read the introductory sections to familiarize yourself with the purpose and scope of the addendum.
- Navigate to Section A.3, which outlines estimands. Fill out the relevant details corresponding to the population, variable, intercurrent events, and population-level summary for your study.
- Proceed to Section A.5, where you will document the main estimation approach and describe the sensitivity analysis aligned with your estimands.
- Ensure to document any intercurrent events as specified in the guidelines, including how they impact your study design and results.
- Review the completed document for clarity and compliance with the ICH guidelines. Make necessary adjustments to align with the instructional framework presented.
- Once all information is accurately filled in, save your changes. You may then choose to download, print, or share the document as required.
Start completing the ICH E9 (R1) Addendum online today to ensure your clinical trial designs are robust and well-documented.
Sensitivity analysis determines how different values of an independent variable affect a particular dependent variable under a given set of assumptions. In other words, sensitivity analyses study how various sources of uncertainty in a mathematical model contribute to the model's overall uncertainty.
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