The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for
Duration : 90 Minutes
Dr. Charles H Pierce,
Charles H Pierce is Medical Director of Pierce One Consulting. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician Read more
This FDA audit training will provide invaluable assistance to investigators and their staff in the
Data keeping for clinical research trials involving human subjects has to be as accurate and valid as possible. Does yours meet the mark?
Course Objectives:
The FDA inspects hundreds of clinical investigators each year to see if they are following regulations and their data is substantiated.
The regulations for clinical trials involving human subjects are
Every person on your investigative team must be schooled in the correct protocols for data handling, not just for the sake of the participants in your study but also in order to avoid being found non-compliant by the FDA. Your data must be accurate and substantiated every step of the way. This online training will show you how to make sure of that.
Course Outline:
• Why accurate data is essential to ensure the safety of study participants.
• The purpose of making sure that all data is accurate, legible, contemporaneous, original and attributable.
• The regulatory requirements for care of source documents.
• What "To Do" with regard to data including corrections?
• What to "Never Do" with regard to data handling.
• What is the best time to review "Raw Data".
• What documents does the FDA review - always.
• Learn who is responsible for "Data Management".
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar will provide invaluable assistance to investigators and their staff in the
• Principal Investigators / Sub-investigators.
• Clinical Research Scientists (PKs, Biostatisticians).
• Safety Nurses.
• Clinical Research Associates (CRAs) and Coordinators (CRCs).
• QA / QC auditors and staff.
• Clinical Research Data managers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
