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Overview

Continuing Education credit is not Available for Archived Online Training.

This program is part of DIA’s Certificate Program and is awarded the following:
Clinical Research Certificate Program: 4 Core Units
Regulatory Affairs Certificate Program: 4 Elective Units 

For more information go to www.diaglobal.org/certificateprograms


This fast-track online course 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 Conference on Harmonization (ICH) standards and must meet high quality standards so that it provides most concise yet comprehensive summary of the study. The course will provide latest strategies for preparing such clear, well organized, ICH-compliant Clinical Study Reports in a most efficient way.

Course Level: Beginner

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
  • Clinical research and development professionals
  • Regulatory affairs personnel
  • 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

Contact us

Registration Questions and
Technical Support

Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details and Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org