ComplianceOnline

Principal Investigator responsibility in Research Involving Human Subjects: The International Conference on Harmonization (ICH) view

Instructor: Charles H Pierce
Product ID: 701077
  • Duration: 90 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: Dec-2008

Training CD

$500.00
One CD is for usage in one location only.
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CD and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

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.

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. The responsibilities are clearly described / outlined in The ICH GCP Guidelines of E6 (4.1 to 4.13). These 13 areas are described and discussed. Additionally, 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. To follow the regulations of Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly.

Areas Covered in the seminar:

  • The Investigators role in the clinical research process.
  • The difference between AEs and SAEs and the reporting requirements of the investigator.
  • Why the investigator maintains a list of staff signatures.
  • Why the investigator files the signed and dated protocol.
  • Why 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.
  • What is the history of the drug / device regulations.

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).
  • QA / QC auditors and staff.
  • Clinical Research Data managers

Instructor Profile

Charles H. Pierce, MD, PhD, FCP (Fellow of the American College of Clinical Pharmacology), CPI (Certified Physician Investigator) is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of the 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, sits on University and industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been active in the Clinical Research Industry for 19 years including 7 years as the PI of a large CRO, has authored a "Manual for Investigators", and 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.

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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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