Writing Clinical Study Protocols
The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval. Over the course of a development plan, new protocols, amendments, and concept sheets will be needed. Protocols for Phases 1, 2, 3 and 4 require different writing approaches and you must know what the agency expects at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process.
- Describe the overall structure of a protocol and regulatory requirements
- Describe the requirements for a protocol
- Understand how study type varies during the different stages of drug/device development
- Design a scientifically rigorous study to meet regulatory needs
- Explain what safety and efficacy is and how you establish either or both
- Identify the hypothesis and develop endpoints to test the hypothesis
- Determine inclusion/exclusion criteria
- Determine the Schedule of Events
- Determine adverse and serious adverse event reporting
- Work with cross-functional teams and use tools to assist in protocol development
- Understand when to amend a protocol
Who Should Attend
- Medical Directors
- Medical Writers
- Clinical Research Associates
- Regulatory Affairs Professionals
- Research and Development Personnel
Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.C.P.
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: firstname.lastname@example.org
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.