This webinar will discuss the steps to prepare an informed consent document under different situations.
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?
Who Will Benefit:
This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians).
- Safety Nurses.
- Clinical Research Associates (CRAs) and Coordinators (CRCs).
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
Instructor Profile:
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. Dr. Pierce serves as an advisor to several clinical research organizations. He has been in the Clinical Research Industry for 20+ years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.
