FDA Clinical Trial Requirements, Regulations, Compliance and GCP (Good Clinical Practice)

Instructor: Carol Owen
Product ID: 701440
  • Duration: 70 Min

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: Apr-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


Read Frequently Asked Questions

In this FDA clinical trial training get guidance and learn to interpret various clinical trial requirements and regulations. The general scientific principles for the conduct, performance and control of clinical trials will be examined.

Why Should You Attend:
Navigating through the various FDA clinical trial requirements, regulations and guidelines can be confusing and time consuming. Failure to comply with the regulations and requirements can be devastating to any clinical project.

This session will include the FDA requirements and regulations for sponsors/CROs and investigators. FDA regulations and guidelines will be integrated with techniques and tips for navigating through the various requirements for clinical trials all in an understandable language. This session will include the requirements for the key documents needed for any clinical study and the requirements for maintaining that documentation. Additionally, the most common FDA inspection findings cited from their BioResearch Monitoring Program will be covered with tips on how to ensure these areas are complied with.

Areas Covered in the Seminar:

  • Clinical Trial Protocol and Amendments.
  • Investigator's Brochure.
  • The FDA Form 1572.
  • The Informed Consent Form.
  • Assurance of IRB Review.
  • Protection of Human Subjects.
  • Financial Disclosure.
  • Electronic Records/Electronic Signatures.
  • Requirements for Sponsors/CROs.
  • Requirements for Investigators.
  • Most cited FDA findings from Bio Research Monitoring Program.
  • Investigator Disqualification.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:
  • Pharmaceutical
  • Biotechnology
  • CROs
  • Research facilities conducting clinical trials

Instructor Profile:
Carol Owen, has been in the Clinical Research Industry for over 20 years. She recently held the position of Director of Quality Assurance for a large Contract Research Organization. She has been involved in training throughout her career particularly in the areas of GCP compliance, FDA regulations and requirements, and audit training. She has specialized in the pharmaceutical clinical trial business having previously worked for an international pharmaceutical company and two international CROs. She has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials.

Follow us :
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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.

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