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Live Webinar on
How Does Compliance with 21 CFR Part 11 Help Ensure Data Integrity and Subject Safety in Clinical Research Date: Thursday, June 20, 2013 Duration:
90 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Charles H Pierce
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.
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The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails,
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and assure that your data is secure and valid? What needs to happen to make data trails secure and real
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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?
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Principal Investigators and sub investigators Clinical Research Scientists Safety Nurses Clinicl Research Associates (CRAs) and Cordinators (CRCs) Recruiting staff QA / QC auditors and staff Clinical Research Data managers
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About Speaker Charles H Pierce Consultant, Clinical Research / Drug-Device Development 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, ... more
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