Course Description

The final guidance, “Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring” was released in August 2013. In addition to the FDA Guidance, there is significant reference to Risk Management in the latest ICH E6(R3), finalized January 2025. The purpose of Good Clinical Practice as described in E6(R3), “Clinical trial processes and risk mitigation strategies implemented to support the conduct of the trial should be proportionate to the importance of the data being collected and the risks to trial participant.” “Effective implementation of risk-based monitoring, including the prioritization of monitoring and other oversight activities directed at processes and procedures critical for human subject protection and maintaining data integrity, should help maximize the quality of a clinical investigation.”

We will examine both the FDA Guidance and ICH E6(R3) regarding expectations and directives to ensure that Risk Management is an integral process in the conduct of clinical trials and the role that CDM can play in ensuring that risk is minimized when it applies to data quality.

Learning Objectives

• Recognize the rationale regarding risk-based monitoring
• Illustrate the active role that CDM is expected to exhibit in this approach
• List the potential CDM reports to assist in identification of data aberrations
• Interpret the way forward for future CDM activities

Who Should Attend

• Clinical Data Managers
• Clinical Research Associates
• Clinical Trial Managers
• Project Managers
• Quality Assurance Personnel

Instructor

Denise G. Redkar-Brown, MT

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Registration Fees

$735*

*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

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#: 0778-0000-25-046-L99-P. Released: 8/25. 

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