Development of a Clinical Study Report

Date(s) And Time(s):
Apr 16 2010 8:00AM - Apr 16 2010 4:00PM

Location:
Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Overview:

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.

WHAT YOU WILL LEARN

· 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

Contact Information:
For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Colleen.Buckley@diahome.org

http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?pr...