Course Description

Although monitoring plans are not defined or specifically required by FDA regulations, the FDA endorses the use of this tool in a Quality Systems management approach to clinical research. The traditional approach to monitoring plan development has relied upon reinforcing SOP-mandated monitoring activities with little focus on project and/or protocol-specific monitoring needs. This web seminar provides participants with concepts and templates to establish a monitoring plan that supports unique project risks and links to valuable data regarding investigative site and Clinical Research Associate (CRA) performance.

Learning Objectives

• Identify the contents of a monitoring plan including affiliated monitoring procedural documents, tools
• Develop a monitoring plan to meet the unique needs of a project and protocol
• Determine the triggers for revisions to monitoring plans and the importance of version control
• Explain FDA recommendations for risk-based monitoring plans
• Describe the relationship of the monitoring plan to the CRA for monitoring and managing site performance, meeting project goals and promoting continuous improvement

Who Should Attend

• Clinical Research Associates
• Project Managers
• Clinical Research Associate Managers

Instructor

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

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Click here for complete trainer biographies

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#: 0778-0000-23-019-L99-P. Released: 2/23.   

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