ComplianceOnline

Investigator responsibility/Legal commitment in drug and device clinical research: the reality

Instructor: Charles H Pierce
Product ID: 700923
  • Duration: 90 min

recorded version

$249.00
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: Aug-2008

Training CD

$500.00
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

To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly.

Description

This Webinar will provide invaluable assistance to investigators and staff with regulatory/ legal responsibilities. It also delves into the complex ethical considerations in pharmaceutical product (drug or device) research involving human subjects.

It must be understood that when the Principal Investigator (PI) signs FDA form 1572 (for IND studies) or the ‘Statement of the Investigator’ (for IDE studies), she or he is signing a legally binding document with a commitment to follow all appropriate regulations.

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. Good Clinical Practice demands a diligent adherence to these regulations.

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?
  • History of the drug / device regulations.

Who will benefit:

For investigators and staff involved in regulatory or legal responsibilities, this Webinar has a wealth of information and guidance. The ethical considerations in research involving human subjects are clearly complex, requiring the astute and practical perspective that this Webinar provides. Individuals who will receive maximum benefit include:

  • Principal Investigators / Sub-investigators.
  • Clinical Research Scientists (PKs, Biostatisticians,& more)
  • 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, CPI is a consultant specializing in bringing the message of GCP 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 18 years, has authored a "Manual for Investigators", and has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator GCP training, and medical monitoring in both drug and device studies.

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria..Credit available for Live webinar Attendees only.

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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).

Product Reviews Write review

Very informative...good speaker.
- Anonymous

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