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Protocol Deviations: Finding the Yellow Brick Road (Part 1 of 2)

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

Day & Time:
June 16, 8:30AM - 10:00AM (Pacific Standard Time)

Session Number:
114

Room Number:
17A

Level:
Intermediate

Type:
Workshop

Title:
Protocol Deviations: Finding the Yellow Brick Road (Part 1 of 2)

Chair(s):
Yvonne P. McCracken, MPH
Vice President, Clinical Operations and Compliance
Rx Trials Inc, United States

Description:
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.

Learning Objective(s):
Describe a framework for minimizing and managing protocol deviations in a clinical trial; Discuss industry best practices.

Presentation(s) & Speaker(s):
Facilitator
Maryrose Petrizzo, MSc
Senior Consultant
Halloran Consulting Group, Inc., United States

Facilitator
Munish Mehra, PhD
Executive Director, Business Development
Tigermed-Macrostat, United States