DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"

This two-part workshop addresses the lack of consistent terminology and methodology for managing and reporting protocol deviations. A hands-on experience will focus on developing a protocol deviation handling plan and classification of protocol deviations.

Part 1 will provide an overview of the DIA GCP/QA community position paper “Life Cycle and Management of a Protocol Deviation.” This position paper represents the inputs of industry experts (including pharmaceutical companies, IRBs, regulatory agency, clinical sites, and others) and provides a common definition for protocol deviations and best practices for categorizing, managing, and reporting study deviations

Preregistration is strongly recommended, and attendees are expected to attend both Part 1 and Part 2.

Part 2 will take place on Monday at 11:00 AM (Session #137).

Workshop sessions will be interactive so attendees are asked to download all handouts to tablet or laptop and bring to both workshop sessions. To secure a seat for this specific workshop, please email annualmeetingprogram@diahome.org, Subject line: Protocol Deviations Workshop.

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The San Diego Convention Center 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 offering will not be recorded.