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Research Site Quality Compliance Programs: Review of Industry Gold Standards

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

Day & Time:
June 18, 8:00AM - 9:30AM (Pacific Standard Time)

Session Number:
315

Room Number:
16B

Level:
Intermediate

Type:
Workshop

Title:
Research Site Quality Compliance Programs: Review of Industry Gold Standards

Chair(s):
Liz Wool, BSN, RN
President and Chief Executive Officer
QD-Quality and Training Solutions Inc., United States

Description:
This workshop provides a review with examples of site quality compliance frameworks and programs. Additionally, this workshop reviews the risk management strategies for sites to use when launching or augmenting their quality compliance framework.

**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 the core elements of a site quality program;Define key risk parameters to be monitored that support site quality; Determine short- and long-term strategies for implementation and augmentation of the site quality program.

Presentation(s) & Speaker(s):
Core Elements: Site Quality Compliance Framework
Christine K. Pierre, RN
President
Society for Clinical Research Sites, United States

Building Quality by Design (QbD) and Quality Risk Management (QRM) Systems into Clinical Site Operations
Marina Malikova
Executive Director, Surgical Translational Research Operations and Compliance
Boston University School of Medicine, United States