Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9 2015

Topics

• Timing of SAP preparation: Advantages of starting early and staying on top
• The Dance: Relationship between the SAP and the Clinical Protocol
• Sections of the SAP, necessary and optional
• Regulatory considerations, ICH E9, E6, and E3
• Using the template to complete your SAP
• List of tables, formatting the tables
• Integrated Efficacy SAP
• Integrated Safety SAP

Who should Attend

• Project managers
• Clinical research managers
• Scientists and R&D personnel involved in evaluating efficacy of a new drug or medical device
• Marketing personnel in drug or medical devices companies
• Documentation
• Quality personnel involved in evaluating safety of a new drug or medical device
• Anyone involved in decision-making for clinical phases of drug or medical device development
• Anyone involved in writing or implementing a SAP
• Bio statisticians