This GCP training will guide you through key component identification of a good GCP audit program, Investigator awareness, Protocol adherence, The Informed Consent process, Evaluation of subject selection, Inclusion/exclusion criteria, data sampling and audit findings assessments.
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.
This Webinar 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 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.
- 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 serves as an advisor to several clinical research organizations. He has been in the Clinical Research Industry for 20+ years, 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.
