Although
monitoring plans are not defined or specifically required by FDA regulations,
the FDA endorses the use of this tool in a Quality Systems management approach
to clinical research. The traditional approach to monitoring plan development
has relied upon reinforcing SOP-mandated monitoring activities with little
focus on project and/or protocol-specific monitoring needs. This web seminar
provides participants with concepts and templates to establish a monitoring
plan that supports unique project risks and links to valuable data regarding
investigative site and Clinical Research Associate (CRA) performance.
- Identify the contents of a monitoring plan
including affiliated monitoring procedural documents, tools
- Develop a monitoring plan to meet
the unique needs of a project and protocol
- Determine the triggers for revisions
to monitoring plans and the importance of version control
- Explain FDA recommendations for
risk-based monitoring plans
- Describe the relationship of the
monitoring plan to the CRA for monitoring and managing site performance,
meeting project goals and promoting continuous improvement
- Clinical Research Associates
- Project Managers
- Clinical Research Associate Managers
Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.
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#: 0778-0000-17-043-L01-P. Released: 4/17.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.