Are your Informed Consents in compliance with new FDA Regulations - An update on the informed consent process

Instructor: Charles H Pierce
Product ID: 701563
  • Duration: 75 Min
This webinar will discuss the steps to prepare an informed consent document under different situations.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2010

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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.

Follow us :
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed