Course Description

In this web seminar, we will discuss how to write effective monitoring visit reports for medical device studies. Participants will learn the purpose for monitoring investigational sites and the importance of documenting the visit. We will examine the requirements for the documentation in the Code of Federal Regulations and ICH, and discuss how the report is used by various stakeholders. Tools will be provided to enable learners to scrutinize various sections of the report to better document what was accomplished on the visit. This documentation supports the adequate monitoring obligation expected by regulatory authorities.

Learning Objectives

• Describe the requirements of documenting monitoring activities for a device study
• Recognize the importance of a well written monitoring visit report, auditable by the regulatory authorities
• Manage site and sponsor activities and document them appropriately

Who Should Attend

• Clinical Research Associates
• Contract Clinical Research Associates
• Lead Clinical Research Associates
• Clinical Research Managers
• All other personnel responsible for writing or reviewing monitoring visit reports for device studies

Instructors

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

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

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

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#: 0778-0000-23-064-L99-P. Released: 7/23. 

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