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Development of a Clinical Study Report

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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.diahome.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

Special Offers 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions and
Technical Support Day of Event

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

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
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

Faculty 

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Registration Fees 

Other Fees

Group Site
$1750.00

Member

Charitable Nonprofit/Academia Member Individual
$350.00
Member Government Individual
$350.00
Member Standard Individual
$695.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$435.00
NonMember Government Individual
$435.00
NonMember Standard Individual
$785.00
Group Discounts

GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This archived online training offering is sold as one complete series and cannot be purchased in parts.


Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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