Implications of the FDA Guidance for a Risk-Based Approach to Monitoring

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description

The FDA’s Guidance for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, the FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring. In August 2013, the agency issued a final guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, the content and the implications to sponsor monitoring and clinical investigation sites will be discussed.

Learning Objectives

  • Discuss the content of the guidance in relation to traditional monitoring plans
  • Assess the implications of the guidance to current monitoring practices and relationships with oversight of Clinical Investigator
  • Explain ways in which the regulatory climate is reflected in the monitoring guidance

Who Should Attend

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


Nikki Christison, B.S. 

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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

*For individual participants, this web seminar qualifies for a reduced individual participant fee of $149. To register, call +1 781.972.5400 or toll-free in the U.S. 800.856.2556.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 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#: 0778-0000-14-058-L01-P.  Released: 8/14.

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