Common GCP Violations and Site Mistakes - How to Avoid them

Instructor: Charles H Pierce
Product ID: 702062
  • Duration: 85 Min

recorded version

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Read Frequently Asked Questions

This webinar will outline common GCP violations and site mistakes found during a FDA investigator site inspection/audit and provide tips on how to avoid them.

Why Should You Attend:

GCP Investigator site audits are a routine and a necessary part of the clinical trial process. If you are participating in a clinical trial or multiple trials as a Principal Investigator, a study coordinator, a monitor, or even as the IRB chances are that you may be audited. This Webinar will cover the most frequently found GCP violations / mistakes that are often found during the audit process.

We will review FDA inspection program details and how to ensure your site is prepared for an inspection. Focus areas would be Key component identification of a good audit program, Investigator awareness, Protocol adherence, The Informed Consent process, Evaluation of subject selection, Inclusion/exclusion criteria, Methods for data sampling and how to assess audit findings and classify significant observations. We will give you helpful hints to help you avoid the common GCP mistakes and hints to enhance the overall audit experience.

Areas Covered in the Seminar:

  • The historical background of why studies are audited and the purpose of audits.
  • The regulatory requirements for the BIMO program.
  • Studies targeted for auditing?
  • How following GCP will end up making you look good to inspectors?
  • How do you prepare for an audit?
  • What Does the Inspector/Auditor look for?
  • What are the common GCP mistakes sites make?
  • How to prevent and detect misconduct and fraud?
  • What happens after an inspection / audit is done?

Who Will Benefit:

This Webinar will provide invaluable assistance to industry study sponsors of pharmaceutical product (Drug or device) research involving human subjects.

Those also benefiting would be:

  • Principal Investigators and sub investigators
  • 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.

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