Full Day Virtual Seminar: Clinical Research GCP training Course

Why Should You Attend:

All CRO's, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process.  Attending this Webinar is a good step toward learning what makes the Good Clinical Practices of Research involving human subjects.

From recruiting subjects to assessing safety of the investigational product and Protocol deviation aversion, this training session covers the high points.

Areas Covered in the Seminar:

Session 1: Why the Investigator must know her/his responsibilities and Legal commitment's in drug and device clinical research from the FDA perspective: How to get your PI more involved in the Clinical Research process.

• The Investigators key role in the clinical research process
• How following GCP helps assure a clean Audit / inspection
• What are the main Investigator responsibilities?
• How is 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?

Session 2: Have a good plan for recruiting study subjects to eliminate the risk of failure.

• How to set up and track your recruiting of subjects
• The challenges of successful recruiting
• How to build a data-base of patients How to recruit more efficiently for a target study Factors involved in getting “On-Time Full Panel” study starts
• The four major steps in the recruitment process and the importance of each

Session 3: Are your Informed Consents in compliance with the new FDA Regulations – an update of the Informed Consent process

• A definition of terms of the “Informed Consent Process”
• How the Nuremberg Code and the Belmont report affect the process
• What are the steps in the process (the 5 “D”s)
• What the new regulations add to the Basic elements of the Informed consent
• What is the “special” process used with Children
• What is the process to determine a child's ability to “Assent”
• How you assure “Comprehension"
• How the Subject “Bill of Rights” affects the IC Process
• What are the most common errors inspectors pick up

Session 4: Why is Accurate Adverse Event Reporting essential for drug safety - How to Assess and report AEs and SAEs

• The CFR definitions of Adverse Events, Serious Adverse Events, and many more
• How to know what an Adverse Event is and when to report it or them
• Understanding laboratory AEs and the "Reference Range" concept
• Common Mistakes in AE / SAE Reporting
• Reporting of Adverse Events - when and to whom
• The Role of Data safety Monitoring in Protecting Human Volunteers

Session 5: How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

• The Primacy of the study Protocol
• What are Protocol “Deviation” and other terms / categories
• The Regulatory requirements for handling protocol deviations and violations
• The importance of documentation of protocol deviations as well as violations
• What is the reason different IRBs define deviations and violations differently
• What is the basis of the difference between a “Deviation” and a “Violation"

Who Will Benifit:

This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including:

• Sponsor Senior Management
• Project Managers
• CRA Managers
• QA/Compliance persons

In CRO's and sites, those benefiting the most would be:

• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA / QC auditors and staff

Instructor Profile:

Charles H. Pierce , MD, PhD, FCP, CPI Has 20+ years experience 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. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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