We are proud to bring back PharmaSUG’s most popular single-day-event (SDE). Mark your 2020 calendars! We are recruiting well-known presenters on a variety of topics related to e-submission, CDISC development, artificial intelligence and blockchain technology. Online registration is slated to open in Spring 2020. Please contact our SDE Co-Chairs, Margaret Hung and Matt Becker, at This email address is being protected from spambots. You need JavaScript enabled to view it. if you have any questions, or are interested in presenting.

Thursday, October 22, 2020 All-Day Pre-Conference Seminar

Time	Presentation (click for abstract)	Presenter (click for bio)
7:30 AM - 8:30 AM	Seminar Registration and Breakfast
8:30 AM - 4:30 PM	CDISC ADaM – Implementation by Example	Richann Watson, DataRich Consulting

Friday, October 23, 2020 Single-Day Event

Time	Presentation (click for abstract)	Presenter (click for bio)
7:30 AM - 9:30 AM	Registration and Breakfast
8:30 AM - 4:30 PM	Conference Program (TBA)

Sponsorship Opportunities

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Seminar and Presentation Abstracts

CDISC ADaM – Implementation by Example
Richann Watson, DataRich Consulting

This course will provide a high-level overview of some of basic ADaM concepts. It is assumed that the attendee will have a fundamental knowledge of the different ADaM structures and principles. The primary focus of the course is to illustrate the implementation of some of the concepts found in both the ADaM Implementation Guide (ADaM IG) and the ADaM Structure for Occurrence Data (OCCDS) documents. Items covered include setting up subject level analysis data set (ADSL) for common trial designs and walking through the process of creating a basic data structure (BDS) starting from a simple BDS and building on it to structure a data set that will support one or more analyses. Additionally, the course will demonstrate how to implement some variables that are only found in OCCDS, such as the standardized MedDRA query (SMQ) and customized query (CQ) variables.

Materials: Printed copy of the slides set up for note taking.
SAS Software Packages: N/A
Intended Audience: Individuals who have a knowledge of different ADaM structures and principles
Length and Format: Full-day lecture

Course Outline:

• ADaM Overview
• SDTM vs ADaM
• Fundamental Principles
• High-level overview of data structures
  • ADSL
    • Illustration of Common Trial Designs
  • BDS
    • Illustration of a simple BDS
    • Build on simple structure by adding additional variables such as
      • Analysis Visit Windowing Variables
      • Descriptor and Indicator Variables
      • Category and Criterion Variables
    • OCCDS
      • Illustration of a simple AE and CM data set
      • Illustration of an OCCDS that does not have coding or a hierarchy
      • Build on a simple AE data set by adding additional variables such as
        • AEs of Special Interest Variables
        • Occurrence Flag Variables

Presenter Biographies

Richann Watson Richann Watson is an independent statistical programmer and CDISC consultant based in Ohio. She has been using SAS since 1996 with most of her experience being in the life sciences industry. She specializes in analyzing clinical trial data and implementing CDISC standards. Additionally, she is a member of the CDISC ADaM team and various sub-teams. Richann loves to code and is an active participant and leader in the SAS User Group community. She has presented numerous papers, posters, and training seminars at SAS Global Forum, PharmaSUG, and various regional and local SAS user group meetings. Richann holds a bachelor’s degree in mathematics and computer science from Northern Kentucky University and master’s degree in statistics from Miami University.