#Barnett
Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archived: The Revised HHS Common Rule: What You Need to Know Now
Course Description
In 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 deadlines.
Video Preview
Learning Objectives
- Appraise the breadth and depth of the Revised Common Rule
- Distinguish the individual changes to each clinical research professional’s role in the research enterprise
- Design a plan for implementation and compliance
- Identify challenges and obstacles to implementation
Who Should Attend
- 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
Instructor
Robert Romanchuk, B.H.S.H., CIP, C.C.R.C., C.C.R.C.P.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.