The ICF Process: Tips on Achieving Optimal compliance and Comprehension (Clinical)
Venue: Online Event
|Event Date/Time: Sep 22, 2010||End Date/Time: Sep 22, 2010|
The ICF process, which involves communication between a consentee (patient/subject) and a consenter (staff clinician/designee), is a vital component to the authorization of any medical intervention or clinical research trial.
IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear communication regarding the ICF content to potential subjects can result in detrimental consequences to the process that can ultimately affect data integrity and patient safety and/or well-being.
This session will discuss the issues and consequences surrounding an inadequate informed consent process and provide tips on how to create an informed consent process that achieves optimal site compliance and subject comprehension.