How to Create and Understand A Statistical Analysis Plan for A Clinical Study

Instructor: Robert S Hoop
Product ID: 701451
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2010

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This training on Statistical Analysis for clinical study will teach attendees how to create and review a Statistical Analysis Plan. The key components will be described in a language understandable both to statisticians and non-statisticians.

Why Should You Attend :
A Statistical Analysis Plan is a critical link between the conduct of the clinical trial and the clinical study report. Regulatory bodies in Canada, Europe, Japan, and the United States expect that the Analysis Plan will meet requirements in pre-specifying inferential analyses and other important statistical techniques. Additionally, pharmaceutical companies expect that the Analysis Plan will provide explicit guidance to be followed by the statistician and the SAS programmer. That guidance will be in the form of clearly written text and mockup tables as well as a table of contents for all tables, figures, and listings. The Analysis Plan presents the biostatistician with an opportunity to open lines of communication among the following personnel: clinical experts, SAS programming, medical writing, senior management in the biostatistics department, and regulatory affairs.

Attend this webinar training to understand how you can create and review a statistical analysis plan for a clinical study that can be easily understood and which meets the expectations of regulatory bodies across the world.

Areas Covered in the Seminar:

  • MS Word use.
  • Websites and Regulatory requirements.
  • Minimizing Bias.
  • Purpose.
  • Who is the Audience.
  • When to Create the SAP.
  • Overlap of SAP and Protocol.
  • Delineating specifics for table formats.
  • Specific Content.
  • Delineating Specifics for Table Formats.
  • Table of Contents.
  • Sample Mock up Tables – details and examples.
  • Q & A.

Who Will Benefit:

  • Junior clinical biostatisticians
  • Biostatisticians who want to switch from non-clinical to clinical biostatistics
  • Junior SAS programmers that will be reviewing SAPs
  • Junior SAS programmers that will be writing SAS programs from the SAP
  • Biostatistics managers who are new to this process
  • Clinical experts who must understand, review, and approve the SAP
  • Regulatory employees of pharmaceutical companies who will review and must understand SAPs
  • Employees of regulatory agencies who are new to the process of reviewing pharmaceutical sponsor’s SAPs.

Instructor Profile:
Robert S Hoop, MPH, is the owner and president of Robert S Hoop, Inc., a pharmaceutical consulting corporation in the San Francisco Bay Area. Hoop has specialized in the pharmaceutical clinical trial business since 1982 having previously worked for 3 international pharmaceutical companies and one international CRO. He has authored 6 peer-reviewed manuscripts and made presentations at 10 professional conferences. He has expertise in a vast array of therapeutic areas and in Phase 1-4 clinical trials. Hoop has been given multiple awards for the quality of his oral presentations.

Follow us :
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada

Refund Policy

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 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. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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