How Does the Recent ICH-GCP E6 Update Affect YOU?
Speaker:Sandra “Sam” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement.
Cost of Attendance:$0
Program Agenda:
- 5:30pm - 6:00pm – Registration & Networking
- 6:00pm - 7:00pm – Educational Presentation
- 7:00pm – 8:00pm – Volunteer Meeting
Program Description: Recently, a long awaited new revision of the ICH E6 GCP Guideline was released as a response to the increase in scale, complexity, and cost of clinical trials. This new revision focuses on updating and clarifying standards for electronic records and essential documents, and investigator and sponsor oversight. As a result, new questions arise about how to best manage the operations and strategy of a trial to ensure that human subject protections are supported, data quality and integrity is maintained, and documentation is properly managed. This session will give you an action plan for how the new guidance affects your trials.
Upon completion of this Webinar, attendees should be able to:
- Review the updates to the ICH E6 GCP Guideline.
- Identify how the finalized ICH guideline affects running clinical trials.
- Identify how the finalized ICH guideline affects sponsor oversight of the clinical trial.
Target Audience:Clinical Research Coordinators and Assistants, Clinical Research Nurses, Data Managers, Safety Managers, Research Scientists, Research Managers
Contact hours:1.0 Contact hours have been approved for through ACRP. Membership is not required to receive contact hours.
To receive contact hours:
- Sign in at the event and attend the program.
- Log on to the ACRP website “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members who do not belong to a chapter
- $30 Non-Members
Refund Policy: NA - *You must be present to receive credit!*
Level: All Levels are welcome