A good protocol follows the marketing department's lead. It is designed to substantiate whether or not the product can meet certain performance criteria. Once you determine the customer requirements the product is designed to meet those specifications.
It's at this point you write down the envisioned indications and claims for the device: what must you say about the device to persuade the user to buy it? These must-have indications should form the foundation of every pivotal protocol.
Substantiate - Convince a prudent professional
The indications lead naturally to the objectives of the trial, which are broad statements of business purpose such as "to substantiate the efficacy and performance of the device" or "to support a 510k", or "to publish a marketing paper." Objectives lead to hypotheses, which lead to endpoints, which are measured by methods, which are statistically analyzed to substantiate or refute the indications.
Intended use, indications for use, and claims
The intended use of the device will dictate how the device will be used in the study (view the patency of the fallopian tube versus open a blocked fallopian tube); indications for use will dictate the patient population for the study (women unable to conceive), while claims describe the success of the device in light of study results.
What you will learn
Specifically, in this workshop, you'll learn how to craft critical protocol elements such as:
[x] Non-significant risk contentions,
[x] The value of clear study objectives,
[x] Writing primary and secondary hypotheses, and what's the difference,
[x] Endpoints and procedures
[x] (Medical) risk analyses and how they relate to adverse event reporting,
[x] Basic and fancy study designs,
[x] Selecting subjects,
[x] IRB considerations,
[x] Sample size calculations (you will not become a statistician!),
[x] Control of study devices,
[x] Adverse event reporting provisions,
[x] Monitoring plans--how much is enough?
[x] Documentation: who keeps what for how long?
[x] Data management provisions,
[x] Data monitoring boards, when needed,
[x] Personnel responsibilities,
[x] Return of unused inventory,
[x] Study registration and publication,
[x] Study cancellation provisions,
[x] Definitions, references, and attachments.
You will receive
[x] A five-hour lecture.
[x] Power Point slides in pdf.
[x] Case studies and exercises.
[x] Handout illustrating relationship between intended use, indications for use, and claims.
[x] An example IDE protocol, FDA approved.
[x] Two weeks to take a 30-minute follow-up quiz.
[x] Two weeks to give course feedback.
[x] An expert instructor, Nancy J Stark, PhD.
[x] 0.55 CEUs and Certificate of Attendance.
A quiz, of course
The five-hour workshop is followed by a half-hour online quiz, taken on your own time within two weeks following the workshop. The quiz is designed to test your learning of the concepts discussed in the lecture and your ability to apply those concepts to real-life issues.
This is an intermediate level course. Participants are assumed to have a basic knowledge of clinical research and device regulations.
Who should attend
[x] Clinical professionals who use or write protocols.
[x] Regulatory professionals who use or write protocols.
[x] Start-up executives planning clinical trials.
[x] Investigators who are developing devices.
[x] Anyone concerned with the conduct of studies.
The workshop will be taught by Nancy J Stark, PhD. Dr. Stark has over 25 years experience in device trials, serves as the US co-chair to ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practices, was identified as one of 100 Notable People in Medical Devices by Medical Device & Diagnostics Industry magazine, and serves on the Editorial Advisory Board of MD&DI. You can learn more about her at Nancy J Stark.
Click HERE to register for 13 January 10.