Risk-Based Monitoring: Successful Planning and Implementation

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Course Description

A fundamental shift has occured in the clinical research industry related to how sponsors satisfy their regulatory and GCP requirements for the adequate monitoring of clinical trials. Recent regulatory authority guidance and industry initiatives are both promoting a modern approach to clinical trial monitoring based upon program and study-specific risk assessments and mitigation plans. In order for clinical research professionals to embrace this industry shift, it is critical that they understand the rationale, concepts, and actual work practices inherent in risk-based monitoring.

This course is designed for clinical research professionals across the spectrum of research organizations, investigational product types, and experience levels. Participants will acquire a deeper understanding of the philosophy of risk-based monitoring and be able to apply this understanding to operational activities including the following:

• Performing program and study-level risk assessments and managing risks

• Writing a risk-based Monitoring Plan

• Designing reports and metrics for central monitoring activities

• Supporting Clinical Research Associates for success in the new monitoring environment

• Preparing Investigators and site personnel for risk-based monitoring

Learning Objectives

  • Compare and contrast risk-based monitoring with a traditional monitoring approach
  • Identify program and study-level monitoring risks
  • Develop a monitoring plan which focuses on mitigating risks at both the program and study levels
  • List the activities, responsibilities, and outputs of Clinical Data Management in risk-based monitoring
  • Describe approaches and techniques for central/remote monitoring and data review
  • Predict changes for Investigators/sites as a result of wider adoption of risk-based monitoring

Who Should Attend

  • Sponsors/CROs Clinical Operations Staff
  • Clinical Research Associates and Managers
  • Clinical Data Management Staff
  • Investigators and Staff
  • Clinical Quality Compliance and Quality Assurance Professionals


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

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Risk-Based Monitoring: Regulatory authority guidance, ICH GCP E6 Guideline, and industry initiatives
  • Risk Assessment: Identifying critical data and risks; evaluating and mitigating risks
  • Monitoring Plans: Considerations, content, and associated quality management documents
  • The Clinical Data Management Connection: Data management as monitoring; central monitoring techniques and reporting
  • Remote Monitoring: Strategies, tools, and responding to findings
  • Research Sites and Risk-Based Monitoring: Managing change, clarifying expectations, and supporting sites through transition

Interactive Activities

  • Risk Assessment Case Study
  • Design a Risk-Based Monitoring Plan Table of Contents
  • Brainstorming Clinical Data Management Reports for Central Monitoring
  • Data Trend Analysis Activity
  • Site Transition Planning

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 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#: 0778-0000-17-010-L01-P. Released: 3/17.


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