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
- Medical Directors
- Medical Writers
- Clinical Research Associates
- Regulatory Affairs Professionals
- Research and Development Personnel
Caroline Ritchie, Ph.D., M.B.A.
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biographies
$835
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.
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#: 0778-0000-20-055-L01-P.
Released: 1/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.