The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors looks for

Why Should You Attend:

Fact: 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 strict, and for obvious reasons. The well being of the subjects must be guaranteed throughout, and the FDA should be able to verify from your data that this is the case. This is why the FDA guidelines for research involving human subjects demand that you leave a clear data trail. To quote from ICH E6 2.10, "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification."

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.

Areas Covered in the seminar:

• 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".

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 all those handling study data including:

• 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

Instructor Profile::

Charles H. Pierce, MD, PhD, FCP (Fellow of the American College of Clinical Pharmacology), CPI (Certified Physician Investigator) is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of the 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, sits on University and industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been active in the Clinical Research Industry for 19 years including 7 years as the PI of a large CRO, has authored a "Manual for Investigators", and 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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