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Protocol Deviations: Avoidable Problems or an Unavoidable Risk
Session Chair(s)
Leslie Sam
President
Leslie Sam and Associates, LLC, United States
There is no consistent terminology or methods to categorize and report protocol deviations. The Good Clinical Practice Quality Assurance (GCP-QA) Community collaborated with industry experts and is working on a paper that will be submitted to a peer reviewed journal for publication. This interactive workshop will share findings and seek your input.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Learning Objective : Describe the framework for minimizing and managing protocol deviation in a clinical trial; Discuss how best to classify/categorize protocol deviations as Critical, Major, Minor or using other groupings; Illustrate how to collaborate on a risk reduction strategy.
Speaker(s)
Facilitator
Maryrose Petrizzo, MS
Clinical Quality Assured,LLC, United States
President and Consultant
Facilitator
Yvonne McCracken, MPH
Carolinas Research Associates, United States
Quality Assurance Specialist
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