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Development of a Clinical Study Report


DIA is pleased to present this fast-track 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 Council 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

Part 1:
Purpose and Organization of a Clinical Study Report and Writing the Introduction

  • Introduction, purpose, and general requirements of a clinical study report
  • Clinical study report organization and hints on authorship
  • Other types of study reports (abbreviated/synoptic reports)
  • Title page, ethics, and study administrative structure
  • Introduction and study objectives
  • Investigational plan through statistical methodology
  • Investigational plan
  • Subject selection criteria

Part 2:
Writing the Investigational Plan and Analysis Approach, Creating Effective Data Displays, and Developing the Study Population and Efficacy Results Sections

  • Investigational plan through statistical methodology (continued)
  • Study treatment and prior concomitant medication
  • Study evaluations
  • Data quality assurance and statistical methodology
  • Effective data presentations
  • Study population and protocol deviations
  • Efficacy results

Part 3:
Developing the Safety Results Section and Guidelines Concerning the Review Process

  • Safety results
    • Adverse events
    • Clinical laboratory test findings
    • Other safety variables
  • Discussion, conclusions, and synopsis
  • Review process

Featured topics

  • Structure and format of a 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
  • Regulatory affairs personnel
  • Clinical research and development professionals
  • Biostatisticians
  • Clinical operations professionals

Learning objectives

At the conclusion of this activity, participants 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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