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

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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.

Speaker
Instructor: Rita Hanover
Product ID: 702783
Training Level: Advanced

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.

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.

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.

Areas Covered in the Seminar:

Who Will Benefit:

Instructor Profile:

Dr. Hanover, has worked in clinical research for over 30 years, as a Principal Investigator for studies funded by national agencies such as NIMH, Veteran’s Affairs, and DOD as well as various private pharmaceutical and medical device companies, as a Professor teaching research methods, biostatistics, and evidence-based medicine at the University of Utah School of Medicine, a Consultant to the Utah State Department of Health, and Director of Clinical Research for Techniscan Medical Systems. She 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).

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.

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"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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Training Options Training Duration = 90 Min
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