Writing the Clinical Study Report

Course Description

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This web seminar presents the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

Learning Objectives

• Translate protocol and data into clear concise submission documents
• Describe the elements required for the CSR and the appendices
• Differentiate the various types of statistical outputs and handling of the results
• Identify the phase of drug development differences and similarities
• Utilize style guides and templates
• Understand how new regulations in transparency impact CSR development 

Who Should Attend

• Medical Directors
• Medical Writers
• Clinical Research Associates
• Clinical Scientists
• Research and Development Personnel
• Regulatory Affairs Professionals
• CRO Personnel

Instructor

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 3 hours (0.3 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-027-L99-P. Released: 1/23. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.