basis and success of any clinical development program is the study protocol.
Clinical trials conducted under an IND or IDE cannot begin without a protocol.
However, there is considerable variability between companies and individuals
regarding the approach to writing this critical document, even with a good
understanding of ICH guidelines. Clinical trials and entire programs have
failed because the protocol was not scientifically sound, and knowing how to
effectively research and write a clinical trial protocol is essential to
achieving IRB and ultimately market approval. Moreover, amendments, however
unwelcome, are a necessary part of the development process and must be managed
efficiently to avoid costly implementation or delays to the ongoing trial.
- Improve basic writing skills, and learn the use
and importance of style guides and templates
- Differentiate between the phases of
investigation for drugs and devices
- Manage the timeline for protocols
and their amendments, including internal and external review, key opinion
leader input, collation, revisions, QC process, sign-off, and meetings
- Navigate the protocol concept sheet
and synopsis; using these as an outline for the protocol
- Describe the requirements for and
elements of a protocol including the hypothesis, clear and concise
objectives, primary and secondary endpoints, inclusion/exclusion criteria,
and the Schedule of Assessments
- Describe adverse events and serious
adverse events and their reporting, depending on type of study and type of
- Develop a basic statistical
understanding (e.g., qualitative and quantitative data, sample size
determination, and interim analysis)
- Develop protocol amendments: how and
when to do it and documentation needed
- New or Intermediate Medical Writers
- Personnel who review protocols —
Medical Directors, Statisticians, Clinical Pharmacologists, Regulatory
- Clinical Research Associates,
Coordinators and Investigators
- Non-Clinical Personnel
- Marketing Personnel
Caroline Ritchie, Ph.D., M.B.A.
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Day One: 8:30 a.m. – 5:00 p.m.
- Writing Basics
- Overview of the Protocol Requirements
- Building the Protocol
- Protocol Amendments
Two: 8:30 a.m. – 5:00 p.m.
- Building the Protocol, cont.
- Past precedence and approved labels
- Constructing protocol based on research
- Informed Consent Form
- Protocol Amendments
- Development of the objectives, review of the
synopsis process, and generation of a Schedule of Assessments
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
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Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 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#: 0778-0000-17-007-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1