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.

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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.

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