Course Description

This short course provides insights into writing a clinical study protocol, a key component for the success of any drug, device or food/dietary supplement development program. A well-designed protocol is essential for IRB and regulatory approval, as poorly designed protocols can lead to trial failure. Understanding the different approaches required for phase 0-4 pharmaceutical trials and pilot or pivotal medical device trials, as well as managing amendments, is critical to avoiding clinical holds and ensuring success.

Learning Objectives

• Describe protocol structure, regulatory requirements and study variations across drug/ device development stages
• Describe the requirements for a protocol
• Design scientifically rigorous studies, establish safety and efficacy and develop hypothesis and endpoints
• Determine inclusion/exclusion criteria, develop the Schedule of Events and specify adverse and serious adverse event reporting
• Work with cross-functional teams, use development tools and know when to amend a protocol

Who Should Attend

• Medical Directors/Writers
• Clinical Research Associates
• Regulatory Affairs Professionals
• Research and Development 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

$835*

*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

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#: 0778-0000-23-026-L99-P. Released: 3/23. 

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