Course Description

Risk-based approaches to clinical trials and risk-based monitoring are now required for clinical trial sponsors under ICH GCP E6 R2 Addendum and the R3 draft. This comprehensive 10-week series provides a step-by-step approach for developing the content of the clinical trial monitoring plan. Specific attention is given to translating the Trial Risk Assessment (TRA) output and Integrated Quality Risk Management Plan (IQRMP) into a well-orchestrated document that is concise, comprehensive, and clearly articulates the complete strategy for all aspects of the monitoring to be undertaken and how risks will be mitigated.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Describe the monitoring responsibilities of a risk-based quality management trial and the key areas to focus on and include in the monitoring plan
• Explain how the TRA and IQRMP outputs are integrated into the monitoring plan
• Identify the stakeholders necessary for monitoring plan development
• Explain inclusion of roles, responsibilities, and communication strategies in the monitoring plan
• Identify content and the components needed for developing a clear and concise risk-based monitoring plan
• Discuss how critical and non-critical data are to be incorporated into the monitoring framework
• Define centralized monitoring activities based on a case study and how to include these activities in the monitoring plan

Course Outline

• Module 1: Monitoring Plan Overview, Stakeholders, and Planning for Success
• Module 2: Deriving Input: Risks, Critical Data/Processes, Mitigation Plans
• Module 3: Case Study: Let’s Get Started
• Module 4: On-Site Visit and Site Management
• Module 5: Off-Site (Remote) Site Monitoring
• Module 6: Centralized/Statistical Monitoring
• Module 7: Escalation and De-escalation/Management of Noncompliance
• Module 8: End of Study Activities and Other Monitoring Plan Components
• Module 9: Drivers for Revisions and Updates
• Module 10: Regulatory Agency Inspections: Helpful Tips

Who Should Attend

• Clinical Trial Managers/Study Leads
• Project Managers
• Clinical Trial Management/Clinical Operations Directors
• Quality Compliance Professionals
• Data Managers and Statisticians

NOTE: This course is for individual registrants only and does not allow for group training.

What previous students have said ...

“I now have more tools and guidance when writing my next monitoring plan for upcoming trials to account for expectations from E6 R2 changes.”

"This series clarified a lot of the questions I had regarding risk-based monitoring and also confirmed that we are on our way to having a great risk-based monitoring plan. The risk assessment lessons were key for me."

“Very helpful guidance to monitoring and data management.”

Instructor

The course will be led by one of the following instructors:

Treena Jackson, M.S., M.A., C.Q.A., R.A.C., C.S.S.G.B.

Heather Marshall, M.S.N., B.S.N., R.N.

Shana Zink, B.S., C.C.R.A.

Click here for complete trainer biographies

Course Length and Time

10 weeks for 2 hours each week.

Registration Fees

$1,695 by Early Bird Deadline

$1,895 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 20 hours (2.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-035-L99-P. Released: 10/22.

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