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Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 1 of 2)

Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:

Room Number:



Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 1 of 2)

Liz Wool, BSN, RN
President and Chief Executive Officer; Past-Member, Board of Trustees, ACRP
QD-Quality and Training Solutions Inc., United States

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.

Learning Objective(s):
Define the key elements of risk management principles; Examine case studies and lessons learned; Evaluate impact on study risk plan.

Presentation(s) & Speaker(s):
Beat Widler
Widler & Schiemann AG, Switzerland

Joan B. Versaggi
Associate Director – Good Clinical Practice Services
Falcon Consulting Group, United States