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 actions plans by regulatory authorities.
Trailer____________________________
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 non-compliance (case scenarios)
Who Should Attend_______________________
- Site Research Directors/Managers
- Clinical Research Coordinators
- Principal Investigators
- CRAs
- Project Managers / CRA Managers
- QA
Instructor ________________________________
Sandra “SAM” Sather, MS, BSN, CCRA, CCRC
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Course Length and Time___________________
1.5 hours 12:30 – 2:00 p.m. Eastern
Course Dates _____________________________
April 27, 2010
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For more information, contact Naila Ganatra at (215) 413-2471.