Development of a Clinical Study Report Course

Date(s) And Time(s):
Feb 14 2011 8:00AM - Feb 14 2011 4:00PM

Gaylord National Hotel and Convention Center
201 Waterfront Street
National Harbor, MD 20745


Introductory Course for Those Who are New to Writing or Reviewing Integrated Clinical Study Reports

This fast-track course will teach you the latest strategies for preparing clear, well-organized, and ICH-compliant clinical study reports.


· Structure and format of an integrated clinical study report in accordance with ICH guidelines

· Investigational plan through 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

Learning Objectives:

At the conclusion of this course, 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 solving problems related to preparation, protocols, patient disposition, compliance, and changes to statistical methods
Develop a comprehensive and easily reviewable clinical study report

Target Audience:

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

Event Code:

For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108