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Overview

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

What you will learn

  • 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

Who should attend?

  • Medical writers
  • Clinical research and development professionals
  • Regulatory affairs personnel
  • Biostatisticians
  • Clinical operations professionals

Learning objectives

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