Drug Information Association Logo
Corporate Tagline

Development of a Clinical Study Report

Mar 11 2014 12:00PM - Mar 13 2014 2:00PM | Online

« Back to Listing

Overview 

This online training will be broadcast in Eastern Time (ET)


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 

Previous Next

Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102, (703) 506-3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .6 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

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

Name Credit Type Max Credits CEU
Development of a Clinical Study Report IACET 6.00 0.600

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the activity.

Continuing education credits are available to learners who participate in the live online training course. Continuing education credits are not available for participation in the archived version of the online training course.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

Agenda  

Day 1 Tuesday, March 11, 2014

  • 12:00PM - 2:00PM

    Part 1: Purpose and Organization of a CSR and Writing the Introduction

Day 2 Wednesday, March 12, 2014

  • 12:00PM - 2:00PM

    Part 2: Writing the Investigational Plan and Analysis Approach and Creating Effective Data Displays, and Developing the Study Population and Efficacy Results Sections

Day 3 Thursday, March 13, 2014

  • 12:00PM - 2:00PM

    Part 3: Developing the Safety Results Guidelines Concerning the Review Process

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 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.

Register Online
« Back to Listing Back To Top