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Feb 1, 2017 by Joan Butler (joanb)
CRA 6211 : Monitoring, Auditing, and Oversight in Clinical Research
Wed, 01 Feb 2017 09:03:06 GMT
Mon, 23 Jan 2017 15:31:20 GMT
Catalog Pages referencing this course
Clinical Research Administration (CRA)
Programs referencing this course
CRA-BSMS: Clinical Research Administration
CRA-GC: Clinical Research Administration
CRA-MSHS: Clinical Research Administration
School of Medicine and Health Sciences
Clinical Research and Leadership (CRL)
Long Course Title
Monitoring, Auditing, and Oversight in Clinical Research
Short Course Title
Monitor/Audit/Oversight in CR
Number of Credits
Default Grading Method
Repeatable for Credit?
MSHS in CRA or graduate certificate student status
Dr. Joan Butler
Frequency of Offering
Are there Course Equivalents?
Are Fees Applicable?
Explanation and Description of Fees
Are Additional Resources Required?
Explanation of Additional Resources
Justification for Additional Resources
Describe any Sources of Additional Funding
Key stakeholder roles, responsibilities, and processes associated with monitoring, auditing, and oversight in clinical trial conduct.
By the end of the course, students will be able to:
• Examine the role of monitoring, auditing and oversight processes and how each process contributes to quality clinical trial conduct.
• Assess the oversight roles and responsibilities of various stakeholders related to clinical trial conduct.
• Evaluate monitoring requirements in order to ensure regulatory compliance and appropriate controls for clinical supplies and safety reporting in clinical trial conduct.
Uploaded a Course Syllabus
CRA 6211 Syllabus.docx
Explanation of how the course differs from similar GW courses
Course Reviewer Comments