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

Part 1 of this two-part workshop will provide an overview of the proactive risk management approach described in ISO 31000 (Risk Management – Principles and Guidelines) as referenced by the FDA in their 2013 guidance Oversight of Clinical Investigations – a Risk-based Approach to Monitoring. The ISO 31000 principles and methods will be reviewed and include topics such as prospective study quality planning with the inclusion of risk monitoring activities. Relevant case studies will be shared that demonstrate the successful and flawed applications of these risk management components.

This workshop has been developed by the DIA Data Management, Good Clinical Practice/ Quality Assurance, Quality Risk Management, and Statistics Communities.

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

Part 2 will take place on Wednesday at 3:30 pm (Session #393).

To secure a seat for this specific workshop, please email annualmeetingprogram@diahome.org, Subject line: Clinical Study Risk Management 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.