Development of a Clinical Study Report

Perspectiva general

DIA is pleased to present this fast-track introductory course which is designed for professionals new to clinical development and Clinical Study Report preparation. The Clinical Study Reports for submission to the Health Authorities are required to be in compliance with the International Conference on Harmonization (ICH) guidelines. The reports must meet high quality standards in providing a concise yet comprehensive summary of the study. This course will provide the latest strategies for preparing clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.
Course Level: Beginner

Lo que aprenderá

Structure and format of an integrated clinical study report in accordance with ICH guidelines
Investigational plans using statistical methodology
Study population and protocol deviations
Placement and presentation of study information and data in various report sections including tables, appendices, and supporting documentation
Safety and efficacy results
Pharmacokinetic and/or pharmacodynamic endpoints
Acceptability of abbreviated study reports

Objetivos de aprendizaje

Participants who complete this training should be able to:

Recognize key regulatory requirements for integrated and abbreviated clinical study reports
Explain the format and structure of a clinical study report
Describe the relationship of the clinical study report to the clinical study protocol
Discuss various approaches to address issues related to patient disposition, compliance and statistical methods in the clinical study report
Develop a comprehensive and easily reviewable clinical study report

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Development of a Clinical Study Report

Perspectiva general

Lo que aprenderá

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Objetivos de aprendizaje

Be informed and stay engaged.