21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research 2018

Topics

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

Who should Attend

• Clinical Research Scientists (PKs, Biostatisticians)
• Principal Investigators and Sub Investigators
• Clinical Research Associates (CRAs) and Cordinators (CRCs)
• Safety Nurses
• QA / QC Auditors and Staff
• Recruiting Staff
• Clinical Research Data Managers