Although
many clinical trial sponsors and investigators focus primarily on FDA regulations
related to the conduct and design of clinical trials, their failure to comply
with state laws and regulations may expose sponsors, investigators, IRBs,
institutions, or individuals may call into question the potential integrity of
clinical data. Today’s U.S.-based clinical trials must meet not just federal
requirements, but an increasingly complex array of state specific requirements,
many of which are critical and foundational to clinical studies. The capacity
to consent to experimental therapy has its foundational basis and is governed
by state law. In this web seminar, we will review many of these key areas, and
discuss specific differences. Learners will be provided with examples from more
than a dozen practical areas, including age of consent, capacity to consent,
IRB and clinical protocol requirements, notification of state agencies,
experimental drug dispensing requirements, HIV testing rules, genetic testing,
and legal representatives. Also, we will explore strategic considerations that
certain states afford specific therapeutic classes. Learners will have the
opportunity to ask direct questions regarding clinical trial requirements in
their research state.
- Recognize areas in which state-specific
regulations may affect clinical trial research
- Reduce risk and liability by
applying state-specific knowledge to clinical trials
- Utilize state licensing authorities
and agencies to address state-specific concerns
- Describe the strategic aspects of
clinical trial site selection
- Site Research Managers
- Clinical Research Associates
- Clinical Project Managers
- Principal Investigators
- Site Research Managers
- Clinical Research Coordinators
John
Serio, J.D.
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 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#: 0778-0000-19-058-L01-P.
Released: 9/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.