FDA Inspectors 2013 - The Secret of Study Conduct Documentation to ensure a successful Audit: What the FDA Inspectors look for

Overview: All Clinical Research protocols have the procedures and processes needed to collect the data as it happens.
The FDA guidelines and regulations for the conduct of research involving human subjects were developed to ensure complete and credible data and, of course, to safeguard the health and safety of human subjects. This is further emphasized in the ICH E6Â 2.10: "All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification", which will allow the creation of a clear and followable data trail. The rules of collecting, correcting, and caring for all original (source) documents must be known by the entire study staff under the direction of the PI. In the end, the entire investigation team is charged with ensuring that the data obtained from trial subjects is accurate and valid. The presentation lays this on the table.
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Areas Covered in the Session:
The Investigators role in the clinical research process
The historical background of why accurate data is essential for ensuring safety of study participants / patients.
The purpose of ensuring 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 is the history of the drug / device regulations?
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Who will Benefit:
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
Clinical Research Data managers
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Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message 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, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. 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.
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