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.

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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

Instructor

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

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