Statistical Concepts for Non-Statisticians
April 13-14, 2015
Philadelphia, PA
Comprehensive Monitoring for Medical Devices
April 8-10, 2015
San Francisco, CA
Monitoring Clinical Drug Studies: Beginner
April 14-16, 2015
San Diego, CA

Monitoring Plan Development

Upcoming Courses
Course #: BI11963
April 7, 2015
8:30 AM - 10:30 AM Eastern
Course #: BI12052
July 16, 2015
1:00 PM - 3:00 PM Eastern

Course Description

Although monitoring plans are not defined or specifically required by FDA regulations or the ICH Guideline for Good Clinical Practice, both organizations endorse 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 set up a monitoring plan that supports unique project risks and links to valuable data regarding investigative site and Clinical Research Associate (CRA) performance. Suggestions for development of monitoring plans for a risk-based approach to monitoring are also provided in this session.

Learning Objectives

  • Develop a monitoring plan to meet the unique needs of a project and protocol
  • Identify factors to consider when developing a monitoring plan for a risk-based monitoring approach
  • Link the plan to CRA and site performance to meet project goals and promote continuous improvement

Who Should Attend

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


This course will be taught by one of the following instructors:

Linda Carter, R.N., B.S.N.

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

Click here for complete trainer biographies 

Registration Fees


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 1-800-856-2556 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 mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-14-024-L01-P. Released: 4/14.

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.