Your clinical protocol has been completed and signed off. Clinical trial material has been distributed to the various clinical sites. Your Investigator and sub-Investigator are ready to begin the clinical trial. Clinical research associates are ready to perform their work in the upcoming trial. You are ready, correct? Think again…
How well do your personnel participating in the trial actually know the trial? Has the investigator brochure been thoroughly reviewed and disseminated? Are your personnel familiar with the regulatory aspects of what is about to transpire? Do your Investigators realize that the Form FDA 1572 is a legally binding document?
These questions and more are generally addressed at an Investigator Meeting. The importance of an Investigator meeting cannot be overstated because it can and will affect patient enrollment/retention, plus have an impact on data quality. Furthermore, this meeting provides an opportunity for researchers to get together to introduce the study as a group. Additionally, it allows for questions to be voiced and heard by all in the audience. Finally it provides adequate training in preparation for the trial.
This webinar will provide an overview of the Investigator meeting and how it should be conducted. By attending this session, you will learn:
- How to plan for the Investigator meeting: Strategizing the regulatory aspects
- Avoiding general pitfalls that derail these meetings – from planning to execution
- The general requirements of a good meeting
- The Regulatory Package – Understanding the necessary documents for a successful clinical trial
- Understanding the legal requirements – dotting “i’s” and crossing “t’s”