The 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. Knowing how to effectively research and write a clinical trial protocol is essential to achieving IRB and ultimately market approval. Over the course of development, new protocols, protocol amendments, and protocol concept sheets are needed on an ongoing basis. Though they require similar information, protocols for drugs, biologics, and devices require different approaches, and may be dependent on phase of development. Moreover, amendments, however unwelcome, are a necessary part of the development process. Amendments 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 intervention
- Develop a basic statistical understanding (e.g., qualitative and quantitative data, sample size determination, and interim analysis)
- Determine what happens next: distribution to regulatory agencies and sites, IRB review
- Develop protocol amendments: how and when to do it and documentation needed
- New or intermediate medical writers
- Medical communications personnel
- Anyone who reviews protocols - medical directors, statisticians, clinical pharmacologists, regulatory affairs personnel
- Clinical Research Associates
- Study Coordinators
- Non-clinical personnel
- Anyone breaking into regulatory writing or switching from one discipline to another (e.g., device to pharma) rincipal Investigators
The course will be led by one of the following instructors:
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Day 1: 8:30 a.m. – 5:00 p.m.
- Writing Basics
- Overview of the Protocol Requirements
- Building the Protocol
Day 2: 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
- Case Report Forms
- Protocol Amendments
- A mock drug will be research
- Development of the objectives, review of the synopsis process, and generation of a Schedule of Assessments
Registration 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# 0778-0000-14-004-L01-P. Released 3/14.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.