eSource Symposium

Track:
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)

Day & Time:
June 27, 9:00AM - 10:30AM

Session Number:
409

Room Number:
156AB

Level:
Intermediate

Type:
Symposium

Title:
eSource Symposium

Chair(s):
Ed Seguine, MBA
CEO
Clinical Ink, United States

Description:
The collection and use of eSource clinical data is rapidly becoming the standard medium for clinical research. Regulatory authorities have been increasingly more vocal of their support for the use of eSource clinical data, a fact that may be helping in the continued adoption of eSource and electronic data capture in general during the conduct and assessment of clinical research.

This symposium will introduce risk-based approaches when electronic data are intended to serve as the source of clinical data. Additionally, we will discuss how monitors and data managers can work together when developing and implementing a risk-based monitoring program. A final topic is the assessment of electronic health record systems that will be the repository of eSource data.

Learning Objective(s):
Discuss the principles of risk-based approaches to successfully using esource clinical data; Identify how to implement a risk-based study monitoring approach to electronic clinical data; Describe methods to successfully assess electronic health records systems that will be used for clinical data.

Presentation(s) & Speaker(s):
A Common Tool for Investigator Site eSource (EHRS) Readiness Assessment
Catherine Celingant, MA
Senior Director, Medical Business Operations, Medical Strategy and Operations
Millennium: The Takeda Oncology Company, United States

eSource and Risk-Based Monitoring: Impact on Sites, Data Management and Regulatory Compliance
Ed Seguine, MBA
CEO
Clinical Ink, United States

Time to Change the Clinical Trial Monitoring Paradigm: Results From Clinical Trials Using eSource and Risk-based Monitoring
Jules T. Mitchel, PhD,MBA
President
Target Health Inc., United States