Key Take Away:
This Clinical Trail Monitoring Webinar will cover the most frequently found GCP violations / mistakes that are often found during the audit process. In addition, how to prevent audit findings you wish were not there.
There is an increasing frequency of real-time FDA Clinical Trial Auditing. It is reasonable to expect that the Sponsor’s Monitors would be invaluable to the Site, CRO and even the Sponsor themselves to find errors and mistakes and correct as well as prevent their future occurrence.
Errors in the GCP guidelines for trial audit is one of the most common problems identified by FDA Investigators and is a main reason for the rejection of clinical data. Good monitoring assures error free data. Forewarned is forearmed.
The Sponsor monitoring system of a clinical research study has a significant responsibility in the Drug Development Process. This starts with preparing a complete Investigators Brochure and from this information preparing the study protocol to be safe and to provide effective data. At this point they are then responsible for choosing sites and Principal Investigators who will conduct the study following both the GCP of clinical research and the federal regulations. To assure an error free conduct they are then responsible for monitoring the study to ensure data validity and integrity and for the reports to the regulatory authorities.
Why Should You Attend:
If you are participating in a clinical trial or multiple trials as the Sponsor, Principal Investigator, study coordinator, monitor, or even as the IRB chances are that you may be involved in the audit process. Thus it is not only the Sponsors responsibility to Monitor studies, it is also it is in the Sponsors best interests so study time and expense is not wasted.
Areas Covered In This Webinar:
• The Sponsor's responsibility in ensuring quality monitoring
• Why Monitor Clinical Studies
• What does a Monitor look for?
• How does a Sponsor or Site prepare for an Audit?
• To understand the importance of a well written Clinical Trial Protocol
• The importance of Protocol knowledge in preventing errors
• What are the top 6 GCP problems found by monitors?
• What are the main strategies to improve an audit outcome?
• What does the FDA look at when Auditing/Inspecting a study?
• What types of studies are targeted for auditing?
• The Sponsors role in preparing a site for an audit
• Describe the main Sponsor Responsibilities with regard to CR study conduct
• Discuss audit preparation tools
• Describe how to prevent Audit findings to prevent a FDA Form 483
Who Will Benefit:
• Drug Development Staff
• Sponsors and Principal Investigators
• Clinical Research Associates
• Study Coordinators
• Project Managers at CROs
• Industry Study Sponsors of Pharmaceutical Products (Drug or Device) Research involving Human Subjects
Charles H. Pierce
Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the Clinical Research field. He now brings 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. He 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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