Archive: Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies
Jun 1, 2020, 21:50 PM
Course Id :
19529
Barnett Code :
BI13468
Date :
May 2, 2019
Conf Date :
May 2, 2019, 11:00 AM
Price :
835.00
Site License Price :
1835.00
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.
- 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)
- Site Research
Directors/Managers
- Clinical Research
Coordinators
- Principal Investigators
- Clinical Research
Associates
- Project Managers
- Clinical Research Associate
Managers
- Quality Assurance
Personnel
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Sort order :
2019050200000000
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Investigator
- Drug Safety
- Nursing
- Project Manager
- Study Site Compliance
- Training
series :
- Clinical Trials & Translational Medicine
content Id :
203170
urlAliasnm :
Web-Seminar-Archives/Corrective-Action-Plans--Essential-Documentation-of-a-Site-s-Response-to-GCP-Deficiencies-May-2019/