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
- 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
The course will be led by one of the following
Jeanne Morris, B.S., MT
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer
Includes up to 20
participants at one site. All participants (up to 20) are eligible for
“Certificates of Attendance,” and accreditation, provided that accreditation
requirements are met. For groups larger than 20 or for additional sites, please
call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 1.5 hours (0.15 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-17-022-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1