Assurances: What are they, Why and When do I need them 2015

Topics

• Individual Investigator Agreement
• Federal wide Assurance
• When these agreements are used
• IRB Authorization Agreement
• The process for establishing these agreements
• Why these agreements are used
• Are there other types of agreements that institutions may enter into and how those would meet the regulatory framework

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