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

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Course Description:

This training on clinical trial Statistical Analysis Plans (SAP) will review writing, timing and specific content of the SAP in the context of FDA guidance based on ICH E9 with references to ICH E3 and E6. We will work through a sample template and discuss how to approach each section for maximum clarity and ease of interpretation at the end of a study.

In this session, we will discuss commonly included sections of the SAP in the context of FDA guidance based on ICH E9 (Statistical Principles for Clinical Trials) with references to ICH E3 (Structure and Content of Clinical Study Reports) and E6 (Good Clinical Practices). References to complete and reliable SAP templates will be provided.

Hear from our Speaker

Why should you Attend?

The statistical analysis plan (SAP) is a key component of a clinical trial. It is a prospective plan of statistical methods not detailed in the Protocol. While the protocol is primarily concerned with design considerations, such as study endpoints, type of control, and treatment groups for comparison, the SAP details the statistical model, analysis populations, and other quantitative analytical aspects of the study.

Areas Covered:

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

Learning Objective:

At the end of the webinar, participants will understand the role of the SAP in a clinical study and be able to use one of the many available templates to construct a complete and concise SAP for their next clinical protocol. Participants who do not need to create these documents will be better able to evaluate a sponsor's SAP for regulatory compliance.

Who will benefit?

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

Topic Background:

The primary purpose of a statistical analysis plan (SAP) is to minimize bias. It should be prepared prior to unblinding the clinical study and should clearly state the proposed methods of dealing with missing data, early withdrawals, and protocol violations, and the way in which anticipated analysis problems specific to the study will be treated. It should also include a sample layout for the data summary tables to be produced.

Registration Options

Avail 12 months unlimited access for a single user.

Material shipped within 15 days post webinar completion & get life time access for unlimited participants.

Speaker Details

Rita Hanover

Rita Hanover

Clinical Research

Dr. Rita Hanover has concurrently held consulting positions for such companies as Pherin Pharmaceuticals, Utah Cancer Specialists, Montgomery-Watson Environmental Engineering, and Planned Parenthood Federation of America. She earned a Regulatory Affairs Certification (RAC) in 2006 through RAPS, and is also a member of the Society of Clinical Research Associates (SOCRA), and the American Statistical Association (AMSTAT).

Refund Policy

Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).