The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions (Clinical Compliance )

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Dec 01, 2011 End Date/Time: Dec 01, 2011
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Description

The 9 “Commitments” on the FDA Form 1572 serve as the PI’s guide to how “GCP” is viewed by the Regulatory Authorities. In addition the ICH E6 Guidelines very clearly spell out the responsibilities of both the sponsor (who in turn is responsible for monitoring of studies) and the Investigator. This webinar will ensure that you are clear as to what the practices are that ensure subject safety and credible data, which are the hallmarks of GCP.

Areas Covered in the Seminar:

- The historical background of why the GCP standards were developed.
- Who is responsible for what?
- The ICH definition of “GCP” and how it is applied.
- The Regulatory requirements to follow to be GCP compliant.
- Who, in the clinical research team is responsible that GCP is followed?
- How to be sure CPU / Site staff know their role in maintaining GCP?

NOTE : Use this Promocode (128600)to avail 10% discount,Valid till December 30 & add another webinar to your shopping cart and get 20% off on its price.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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