January 2017, the Revised Common Rule (45 Part 46) was published, providing an
update to GCP. The Rule is notable as much for what it does not contain as for
what it does. This web seminar reviews the following changes: New/modified
definitions; biospecimens and identifiable information; informed consent; broad
consent; IRB continuing review; IRB limited review; new/modified exclusions and
exemptions, and single IRB requirements for cooperative research.
Implementation of the new Rule is required by January 19, 2018, while the
cooperative research requirements are not effective until January 20, 2020.
This web seminar will go beyond a simple review of the changes and focus on the
immediate implications of the new Rule and next steps for each party in the
clinical research enterprise to achieve compliance at the implementation
- Appraise the breadth and depth of the Revised Common
- Distinguish the individual changes
to each clinical research professional’s role in the research enterprise
- Design a plan for implementation and
- Identify challenges and obstacles to
- Clinical Research Managers
- Clinical Research Educators
- Regulatory Specialists
- Clinical Research Associates
- Clinical Research Coordinators
- Project Managers
- Quality Assurance Professionals
- Clinical Investigators
- IRB Members and Managers
Romanchuk, B.H.S.H., CIP, C.C.R.C., C.C.R.C.P.
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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 2.5 hours (0.25 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#: 0778-0000-17-015-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1