ICH GCP E6 (R2): From the site’s perspective
The International Council for Harmonisation (ICH) published a revision to GCP E6 based on feedback from the global clinical research community, advancements in technology and risk management developments. ICH states that the goal of the changes is to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct oversight, recording, and reporting while continuing to insure human subject protection and data integrity”. This presentation will address the amendments and additions to the investigator responsibilities at a research site as well as best practices to meet those requirements.
This is a 30 minute internet media player video of a voice over slide show.
A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.
At the completion of the webinar, participants should be able to:
- Describe the ICH GCP E6 (R2) changes for Investigator Responsibilities at a research site
- Understand the rationale for changing the fundamentals of the monitoring process
- Recognize how the (R2) Risk Base Monitoring will affect the Site
Mr James Simmer BSN, MBA
Jim Simmer is President and Founder of Research Answers. A clinical research consulting company that specializes in innovative solutions that benefit both Sponsor and Investigative Sites. He has over 13 years experience in clinical research and a MBA from Temple University. He built Research Answers on the foundation of personalized, well planned, and dedicated delivery of services.
Prior to founding Research Answers, Jim held diverse management positions for both pharma companies and research sites that has allowed him to gain a unique perspective in the Industry. A frequent lecturer on advanced site management topics, he has been a presenter at the Association of Clinical Research Professionals Global Conference and a speaker for the Society of Clinical Research Associates (SOCRA).
Members - $35
Non-Members - $110 (includes 1 year membership)
Register (If you are not a current member, you will be asked to create an account to view the online training)
Continuing Education Credit Hours:
SOCRA designates this educational activity for a maximum of 1 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit(s)(TM). Physicians should claim credit commensurate with the extent of their participation in the activity.
CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.
CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
SOCRA Members Fee: $35.00
Non-Members Fee: $110.00
Termination Date 8/1/20