This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being.
Areas Covered in the Seminar:- 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
