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Why Should You Attend:
Are you up-to-date with the new FDA Regulations As you provide subjects with the information to make an informed decision as to whether or not to proceed and join the experimental trail. The Webinar will inform you about the “process” of informing potential study participants, in their language and at their educational level, which is one of the major challenges a study site has. You will also see the 8 (Soon to be 9) regulatory “Essential Elements” and also the 6 “Additional Elements” of the IC. You will learn the three parts of the informed consent process. You will also learn what comprises the pediatric “consent Process” and how it differs significantly from the adult process?

Areas Covered in the Seminar:

A definition of terms of the “Informed Consent Process”.
How the Nuremberg Code and the Belmont report affect the process.
What are the steps in the process (the 5 “D”s).
What the new regulations add to the Basic elements of the Informed consent.
What is the “special” process used with Children.
What is the process to determine a child’s ability to “Assent”.
How you assure “Comprehension”.
How the Subject “Bill of Rights” affects the IC Process.
What are the most common errors inspectors pick up?