New Part 11 Guidance for Clinical Trials: What This Means for You 2015 is a webinar that covers topics such as:
- 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
New Part 11 Guidance for Clinical Trials: What This Means for You 2015 is intended for:
- 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
