Course Description

Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.

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Learning Objectives

• Define clinical research essential documentation
• Determine essential subject and non-subject specific documentation requirements per trial
• Discuss essential documentation for drug vs. device vs. combination products
• Prepare for regulatory inspection: Proactive and reactive use of essential documentation

Who Should Attend

• Clinical Research Coordinators
• Principal Investigators
• Research Site Managers
• Clinical Research Associates
• Quality Assurance Personnel
• Project Managers
• Clinical Research Associate Managers

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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