New Part 11 Guidance for Clinical Trials: What This Means for You 2015

Topics

• Requirements of 45 CFR 142 and 160
• Requirements of 21 CFR Part 11
• Tips to get all staff on board in limiting access to authorized personnel only
• Electronic records: Why duties must be segregated to ensure integrity of data, Logins, Passwords and individual accounts, Data entry: proper protocol to follow for source data

Who should Attend

• Clinical research coordinators
• Human subjects research personnel
• Administration in charge of clinical research
• Investigators
• Personnel involved in health plans and health care clearing houses
• Regulatory affairs
• Documentation
• IT/ IS
• Software vendors