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

Instructor: Charles H Pierce
Product ID: 701348
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Training CD

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Read Frequently Asked Questions

This Clinical Research training will guide you on Secret of Study Conduct Documentation to ensure a successful Audit and what FDA inspectors looks for.

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 E6 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 follow able 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.

Areas Covered in the seminar:

  • 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".

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:
  • 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, 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 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 in the Clinical Research Industry for 19 years, 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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