Development of a Clinical Study Report

Venue: Park Hyatt Philadelphia at the Bellevue

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Oct 30, 2006 End Date/Time: Oct 30, 2006
Report as Spam


This course provides an in-depth analysis of the preparation of an integrated clinical study report for pharmaceutical products in accord with ICH guidelines. The structure and format of a clinical study report is explored, with special attention given to the inclusion and presentation of study-specific information and data. While the course emphasis is on developing a clinical study report for efficacy and safety trials, the format and structure of a study report for trials including pharmacokinetic and/or pharmacodynamic endpoints are discussed. Situations under which an abbreviated study report is acceptable are defined, and the format and structure of an abbreviated study report are reviewed. Insight is provided on how to prepare high quality reports that are complete, free from ambiguity, well organized, and easy to review.

Key Topics
•Structure and format of an integrated clinical study report in accord with ICH guidelines
•Placement and presentation of study information and data in various report sections, including appendices
•Strategies for developing clinical study reports that are well organized, unambiguous, and easy to read.


Broad and Walnut Streets
United States