This
web seminar has been designed for the clinical investigator seeking an understanding
of their role and responsibilities in the conduct of clinical trials. We will
focus on the investigator’s responsibility to ensure human subject protection
and data integrity in the conduct of clinical trials. Specific topic areas
include: Delegation to and oversight of clinical research teams, FDA regulations
and appliable guidance documents, Good Clinical Practice (GCP), ICH GCP E6 R2,
adverse events, and FDA inspections and sponsor audits.
- Describe the clinical investigator roles and
responsibilities in the conduct of human clinical trials
- Identify appropriate investigator
delegation and oversight
- Define GCP and ICH GCP E6 R2
requirements for clinical investigators
- Recognize adverse events and
reporting requirements in clinical trials
- Define types of FDA inspections and
sponsor audits
- Clinical Investigators
- Sub-Investigators
- Clinical Research Team Members
wanting to better understand the clinical investigator role and
responsibilities in clinical research
Marla
Hoelle, BSN, RN, CCRA, ACRP-PM, PMP
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#: 0778-0000-20-092-L04-P. Released: 9/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.