Changes to the Common Rule (45 CFR 46) : What this means for you 2016

Topics

• Current literature regarding what research participants want
• Historical perspective on what brought these proposed changes
• Changes most relevant to clinical research
• Proposed changes to 45 CFR 46
• The potential impact to researchers

Who should Attend

• Clinical Research Scientists (PKs, Biostatisticians,)
• Principal Investigators / Sub-investigators
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Safety Nurses
• QA / QC auditors and staff
• Recruiting staff
• Human Research Protection professionals
• Clinical Research Data managers