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.
Why should you Attend:
The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed.
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?
Who Will Benefit:
Principal Investigators and Sub Investigators
Clinical Research Scientists (PKs, Biostatisticians)
Clinicl Research Associates (CRAs) and Cordinators (CRCs)
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.