CDISC Hands-on Workshop

SDTM ADaM Implementation FAQ

 

Introduction:

We are pleased to bring this hands-on CDISC Workshop.  The workshop is an extension of the existing PhUSE “SDTM ADaM FAQ” working group. 


Purpose:

This workshop will start with providing the attendees with an overview of what’s new in CDISC.  However, the main goal of the workshop is to conduct an workshop building on the work of the PhUSE “SDTM ADaM FAQ” working group.
 

Agenda:

1. CDISC – What’s New? – 20 minutes
We will discuss the latest CDISC Data Standards developments and various CDISC organisational updates.

2. Group work to discuss four-six major SDTM ADaM implementation topics – 30 minutes
An example of implementation topics are:

  • Adjudicated Data Process
  • Submission of ISS/ISE data
  • Validation / Conformance Rules

The actual discussion topics will be announced to the workshop attendees in advance before so attendees can research the topic and prepare discussion points.

3. Overview of past and current SDTM-ADaM FAQ Deliverables and best practices – 20 minutes
We will provide a short overview of the SDTM – ADaM Implementation Group activities and highlight the most important best practices that have been made available.

4. Review, next steps and discussion – 20 minutes
Group discussions will be noted on and discussed. The workshop will try to identify the next steps and attendees are encouraged to join the SDTM-ADaM Implementation Group to continue their contributing to the implementation topics.

Workshop Organisation:

  • Attendees are required to bring their laptops to the workshop
  • A discussion lead will be assigned per discussion topics to take notes and provide a review of the discussion
  • The discussion topics will be provided prior to the workshop to allow attendees to read up on the topic and prepare discussion points.


Hands-on Workshop Lead:

Peter van Reusel, CDISC

Amy Palmer, CDISC

 

 

Hands-on Workshops are free to attend, but require pre-registration. Contact the PhUSE Office to register.

 

 

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