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.

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 

Registration Fees

$835

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. 

Accreditation Information

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#: 0778-0000-20-084-L04-P. Released: 7/20.  

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.