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Managing Protocol Deviations: Applying the Protocol Deviations Working Group SOP for Handling Protocol Deviations in Clinical Trials
Session Chair(s)
Maryrose Petrizzo, MS
President and Consultant
Clinical Quality Assured,LLC, United States
This workshop will provide a sample clinical trial protocol and corresponding protocol deviation handling plan (PDHP) along with the standard operating procedure (SOP) and protocol deviations reporting form. Several protocol deviations (PD) will be provided and workshop attendees will be asked to follow the PDHP to handle the classification and reporting of the PD.
This workshop was developed by the DIA Good Clinical Practice and Quality Assurance Community and the Protocol Deviations Working Group.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Walter E. Washington 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 : Review the sample protocol, standard operating procedure (SOP) and corresponding protocol deviations handling plan and tracking form; Apply the SOP and PDHP to protocol deviations reported during the sample trial; Review if any changes are required to the SOP, template or form and any next steps to increasing adoption in industry to the proposed SOP, template and form.
Speaker(s)
Facilitator
Munish Mehra, PhD, MS, MSc
Tigermed, United States
Senior Principal Biostatistician and Executive Director Biometrics
Facilitator
Sandy Mohan, PhD
Immune Design, United States
Vice President, Quality and Compliance
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