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Archive: 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, including:
- Establishing the indication(s)
- Understand the types of studies
- Develop the protocol design (single blind, double blind, randomized, etc.)
- Identify the hypothesis
- Explain what safety and efficacy is and how to establish either or both
- Determine inclusion/exclusion criteria
- Determine the Schedule of Events
- Determine adverse and serious adverse event reporting
Who Should Attend
- Medical Directors
- Medical Writers
- Clinical Research Associates
- Regulatory Affairs Professionals
- Research and Development Personnel
Caroline Ritchie, Ph.D., M.B.A.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.