Course Description

Non-compliance at research sites requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: Ultimately improved human subject protections and data integrity. Lack of these components can lead to repeated non-compliance and in some cases to rejection of corrective action plans by regulatory authorities.

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Learning Objectives

• Define non-compliance
• Determine who is responsible for corrective action planning
• Recognize components of corrective action planning
• Identify examples of corrective action plans for different levels of noncompliance (case scenarios)

Who Should Attend

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

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