ComplianceOnline

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

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

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 :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading