An
audit is defined as a systematic and independent examination of trial-related
activities and documents to determine whether the evaluated trial-related
activities were conducted, and the data were recorded, analyzed, and accurately
reported according to the protocol, the sponsor’s standard operating procedures
(SOPs), good clinical practice (GCP), and the applicable regulatory
requirement(s). Auditing focuses on the systems that generate this data,
whereas monitoring tends to focus primarily on the data. Risk-based approaches
to auditing, such as focusing on the most critical data elements, are more
likely to ensure subject protection and overall study quality, and will permit
sponsors to focus their compliance efforts more effectively. This web seminar
will provide an overview of risk-based auditing skills and techniques, and a
review of recent GCP audit findings from Clinical Investigators (sites), sponsors,
and Institutional Review Boards (IRBs).
- Review similarities and differences in risk-based
auditing and monitoring
- Examine the structure of the quality
assurance/quality control relationship
- Apply risk assessment and management
principles to clinical quality assurance
- Review elements of risk-based
auditing and compare to traditional auditing practices
- Discuss how the timing of the audit
impacts risk assessment and control
- Evaluate recent noncompliance trends
and regulatory focus for sites, sponsors/CROs/monitors, and IRBs
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance
Professionals
- Clinical Research Associates
- Project Managers
- Sponsor Investigators
Elizabeth
Ronk Nelson, M.P.H.
Click here for complete trainer
biographies
$735
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 2 hours (0.2 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#: 0778-0000-20-081-L04-P.
Released: 10/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.