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.
Areas Covered in the Session: - The definition of the "Informed Consent Process" per regulations
- The ethical standards surrounding the informed consent process
- The roles of parties responsible for an adequate ICF process per FDA regulations
- Barriers that affect subjects` comprehension to the essential elements of the Informed Consent
- The most common deficiencies noted in the Informed consent Process
- The effects and consequences of an "inadequate" informed consent process
- Tips on how to achieve site compliance and ensure subject comprehension to the ICF process
Who Will Benefit: This webinar will provide valuable information to personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.) as well as CROs and investigator sites conducting clinical trials including:
- Clinical Research Associates
- Study Managers
- Site Staff/ Study Coordinators
- Clinical Investigators
