When
applied to electronic Trial Master File (eTMF) oversight, risk-based management
is the combination of the potential of quality issues occurring and the impact
these deficiencies may have on the integrity of the TMF and the overall Good
Clinical Practice (GCP) impact on the study. The TMF is comprised of many
records and documents, and a quality TMF is defined as a collection of records,
which is complete, collected in a timely manner and comprised of quality
records. In the past several years, regulatory agencies have been very clear in
their expectation that a sponsor presents a quality TMF during an inspection.
This web seminar will examine the concept of a risk-based approach to TMF
management and oversight, and, its application to TMF oversight. Included are
processes for conducting and documenting quality control (QC) activities that
will ensure a high quality eTMF. Quality review findings can then drive the
need for additional quality review activities, and by applying these concepts,
the sponsor ensures TMF inspection readiness.
- Discuss the application of risk-based assessment
to establish a plan for conducting eTMF QC activities
- Explain various QC activities to
ensure a high quality eTMF
- Identify key TMF artifacts with
significant risk for quality issues
- Trial Master File Directors
- Trial Master File Managers
- Trial Master File Coordinators
- Clinical Operations Directors
- Trial Managers
- Records Management Team Members
Donna
W. Dorozinsky, R.N., M.S.N., C.C.R.C.
Click here for complete trainer
biographies
$835
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#: 0778-0000-19-011-L01-P.
Released: 1/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.