How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research

Charles H Pierce
Instructor Charles H Pierce
Product Id 600029
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

How does compliance with 21 CFR Part 11 help ensure data integrity and subject safety in clinical research

Overview:
Electronic medical records and electronic handling of study data is increasingly common.

To involve computer systems in clinical research implies knowledge of 21 CFR Part 11(ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential. Basically electronic records and electronic signatures must be trustworthy, reliable and generally equivalent to paper records and signatures executed on paper. The differences between the traditional paper system and an electronic system is significant. One must know and follow the Part 11 code. System validation has many items to follow but none more important than the who, what, and when aspect of the Data / Audit Trail. These trails must be secure, operator independent, computer generated, date & time stamped, and (most importantly) available for the FDA reviewer. SOPs and staff training is often what separates the good from the not good systems. This presentation is for the non-computer literate clinical research staff.

Areas Covered in the Session:

  • The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid?
  • What needs to happen to make data trails secure and real
  • What questions should you internal QA department ask to be sure your system is functioning correctly?
  • What controls need to be in operation for an open system?
  • What are the controls needed for a valid electronic signature?
  • The Role of Standard Operating Procedures and staff training in a functional Electronic Data Capture system
  • What are the suggested controls to ensure authenticity, integrity and confidentiality of your EDC system?

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 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
Speaker 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 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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