These short courses delivered by webinar to your computer provide the latest regulatory guidance and how to apply it to your clinical research activities. These webinars can be used to update knowledge for experienced staff or as a series of educational opportunities for the newer staff. Check back frequently for new course announcements.
SOP Design and Preparation
This 2 hour webinar will provide instruction on how to design the procedures and document them in practical SOPs that will provide your organization will greater consistency and higher quality results. Once the SOPs are written and implemented, your organization will have a standard method for day to day clinical trial procedures that will improve your quality and provide more compliant results.
Procedural design will include how to create step-by-step directions from your clinical trial processes. Discussions on implementation, training and maintenance will also be included.
Case studies and examples of SOPs will be discussed.Learn More
The Importance of SOPs
Lorraine Ellis will be discussing the importance of implementing and following Standard Operating Procedures. Training and implementation, Maintenance, and References will all be discussed.
Improving Site Performance
We review key attributes of highly performing sites and discuss actions to improve poor site performance.
Keep your site compliant. This course will teach you how the latest FDA information affects your daily clinical trial activities. You may need to change what you currently do to continue to be compliant.
Clinical Trial Documentation
Review of essential trial documents and their specifications and suggested systems and procedures for getting the documentation right the first time.
Draft Guidance for Industry Oversight of Clinical Investigations - A Risk Based Approach to Monitoring
Learn FDA’s new guidance on monitoring, hear how FDA is going to change FDA procedures and auditing guidelines to address this new Risk-Based Monitoring, and learn how to develop new types of monitoring plans.
Monitoring in the 21st Century: What the Investigative Site Needs to Know
This webinar discusses how FDA’s new draft guidance on Risk-Based Monitoring will affect Investigators and Coordinators’ daily study activities as well as when the monitor is performing monitoring activities.
Contact Us at 585-381-1350 for more information.
Cancellation Policy: All cancellations must be submitted in writing. If you cancel your reservation 31 days before class you will receive 100% refund of the course fee. Cancellations received 14-30 days before class will be refunded less a 15% administrative charge. There are no refunds for cancellations made lass than 14 days before class. Substitutions are allowed. If you are unable to attend the class you registered for, your payment may be applied to a future Research Dynamics webinar.