ICH GCP E6 R2 and R3 Updates: Impact on Clinical Data Management

Course Description

Clinical Data Management plays a significant role in the performance of clinical trials. ICH GCP E6 R2 reinforces the requirements in regards to electronic systems and the Standard Operating Procedures (SOPs) that govern processes specific to these systems. In this web seminar, a review of these requirements as well as an examination of the components of quality management are covered. Further, the role that risk has on the overall conduct of clinical trials will be discussed, particularly since this concept will be the standard way forward (rather than an option). We will also review recommended approaches, industry standards/best practices to achieve compliance with the requirements. Implications of the R3 updates will also be discussed.

Learning Objectives

• Define the recommended SOPs associated with electronic systems used to collect clinical trial data
• Discuss data integrity issues described in the final guideline
• List the considerations of risk associated in clinical trial conduct and its connection to Clinical Data Management
• Review the principles of quality management as related to clinical trials and the tools utilized to implement a quality approach

Who Should Attend

• Clinical Data Managers
• Clinical Data Scientists
• Clinical Quality Assurance Professionals
• Clinical Compliance 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 1.5 hours (0.15 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#: 0778-0000-22-022-L04-P. Released: 7/22. 

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