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Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 2 of 2)
Session Chair(s)
Liz Wool, BSN
President
Wool Consulting Group Inc., United States
The lessons learned from Part 1 of this two-part workshop will provide the foundation for participants to apply the learned principles. Participants will have the opportunity to develop a study risk plan, identify and prioritize the risks, and determine a control plan (including tolerance levels). Participants will analyze factors critical to quality and successful study execution for the development of a risk management plan.
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 1 will take place on Wednesday at 1:30 pm (Session #367).
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 : Identify the foundational principles discussed in the Part 1 workshop to develop a study risk plan; Perform critical analysis of study risk plan.
Speaker(s)
Facilitator
Johann Proeve, PhD
Cyntegrity, Germany
International Medical Officer
Facilitator
Kristin M. Neff, MS
InVivo Therapeutics, United States
Vice President, Clinical Operations and Project Management
Facilitator
Dale Usner, PhD
Statistics & Data Corporation (SDC), United States
CSO and Sr. VP, Strategic Scientific Consulting
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