Data Quality in Clinical Trials: Rationale and Impact

Course Description

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

In this web seminar, we will explore the data quality definitions, processes involved in determination of quality, and the rationale utilized in ensuring data quality. It’s not about the individual data point anymore.

Learning Objectives

• Describe a quality system approach for assuring appropriate data quality
• Identify data discrepancies, errors, outliers and bias and how to assess their importance
• Describe how poor data quality may or may not impact study operations or analysis
• Compare and contrast common approaches to discrepancy identification and resolution

Who Should Attend

• Clinical Data Managers
• Quality Assurance Personnel

Instructor

Denise G. Redkar-Brown, MT

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-20-068-L04-P. Released: 10/20.  

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.