ICH
GCP E6 R2 Section 5.0 has given the clinical research industry the guidance to
incorporate and customize all facets of risk management in clinical trials.
Section 5.0.4, Risk Control, asks that predefined quality tolerance limits
(QTLs) be established considering the medical and statistical variables that
can impact subject safety or the reliability of trial results through the
identification of systematic issues. Once detected, those issues can be
evaluated and acted upon. In this web seminar, participants will learn the
methodology for establishing, evaluating, and maintaining appropriate QTLs as
they relate to clinical research trials.
- Define QTLs and understand their purpose
- Evaluate the requirements that
propel the development of QTLs
- Examine the protocol to identify
critical processes that may impact subject protection and/or data
integrity
- Document the development process
- Implement established QTLs
- Track and assess data to establish
whether they are within QTLs
- Respond when the QTLs are exceeded
- Recognize evolution of QTLs over the
life of a clinical trial
- Modify QTLs depending on
circumstances
- Document to justify any changes to
QTLs
- Managers/Directors: Clinical Operations, Quality
Management, Compliance
- Clinical Quality Assurance
Professionals
Celeste
M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP
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.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com
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#: 0778-0000-19-022-L01-P.
Released: 2/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
