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Data Validation: We're using EDC, then why so many data discrepancies?



2017

Overview

Understanding and implementing Data validation is one of the core competencies for all Data Managers. With the move to EDC, and the promise that "data that would be 'cleaner", why do our EDC systems find more discrepancies than ever before? Are the sites getting sloppy? Has risk based monitoring missed the mark? Or perhaps our implementation of data validation, utilizing EDC systems, has not adapted to real time data collection?

Learn how data validation is best implemented in the EDC Paradigm of data collection.
What purpose does finding the data discrepancy serve? Does resolving the discrepant data improve Quality? Accuracy? Safety and/or Efficacy? These questions will be reviewed and answered during this exciting fast paced Webinar. Suggestions for process improvement related to Data Validation will be presented. Along with a thorough review of how EDC systems introduced process change, that we may not have realized, resulting in an abundance of data discrepancies.

Learning Objectives

  • Identify discrepancies that are relevant to data quality
  • Learn data validation methodology that best suits using EDC
  • Understand the process change needed for real-time data validation

Who should attend

Data Managers with intermediate through advanced levels of experience with determining Data validation checks. Participants will benefit from this Webinars' review of current Data Validation methodologies used in EDC systems.

Meet the Instructor

Maxine Pestronk, MS, RD, LDN, CCDM - Founder & CEO Passion for Clinical Data Management (P4CDM)

Maxine has been in the Clinical Trial industry since 1993. Having worked for Contract Research Organizations, EDC Software, Pharmaceutical and Biotechnology companies, Ms. Pestronk has an array of experiences in the field of Clinical Data Management. Many of Maxine's years in the industry were in roles related to training of data managers; reengineering process for conducting studies using EDC systems; and demonstrating the usefulness of quality metric programs. Maxine has been a member of the SCDM Education Committee since 2009, has authored 6 online courses and 5 Webinars.
Ms. Pestronk has a Master of Science in Computer Information Systems, is a Licensed and Registered Dietitian (RD / LDN) and is proud to be a Certified Clinical Data Manager (CCDM®)!

Earn CEUs

Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.

Webinar registration

SCDM members: $50
Non-members: $175

Not yet an SCDM member? Purchase this conference session and get a one-year membership with SCDM on us to enjoy all our educational programs and sessions at a discounted price.