ComplianceOnline

Investigator responsibilities and Legal commitments in Drug and Device Clinical Research: The Reality or How to get your PI more involved

Instructor: Charles H Pierce
Product ID: 702063
  • Duration: 80 Min

recorded version

$299.00
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: Sep-2011

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will focus on the principal investigator's role and responsibilities, the legal language of FDA form 1572 or Device equivalent and how you can ensure a celan audit by following GCP.

Why Should You Attend:

When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.

This training, by a physician investigator with 20+ years experience, will cover the regulations for both drug and device clinical research in a user friendly way.

Areas Covered in the Seminar:

  • The Investigators key role in the clinical research process.
  • How following GCP helps assure a clean Audit / inspection?
  • The difference between AEs and SAEs and the reporting requirements.
  • What are the main Investigator responsibilities?
  • How is the investigator is responsible for the IC process?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?

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 and 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 has been in the Clinical Research Industry for 20+ years, has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

Topic Background:

In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with “I agree”, one with “I have read and understand”, and one with “I will ensure”.

Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards), and 21 CFR 312 (Investigational New Drug Application / IND). For Device studies, 21 CFR 812 (Investigational Device Exemptions / IDE) is added in place of 21 CFR 312. Additional responsibilities are clearly outlined in The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and not follow these regulations is folly.

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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 customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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