Date(s) And Time(s):
Mar 29 2012 8:00AM - Mar 29 2012 4:00PM

Location:
DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

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

Overview:

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 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

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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
Biostatisticians
Clinical operations professionals

Event Code:
12408

Contact Information:

For registration questions, please contact Vicki Adkinson at +1-215-442-6162 or Vicki.Adkinson@diahome.org
For agenda details, please contact Colleen Buckley at +1-215-442-6108 or Colleen.Buckley@diahome.org