Therapeutic Area (TA) Standards Overview

Date and Time:
THU, 20 JUN 2019, 10:00 AM - 11:30 AM Central US Standard Time 
 
Description:
Therapeutic Area (TA) Standards extend the Foundational Standards to represent data that pertains to specific disease areas. TA Standards include disease-specific metadata, examples and guidance on implementing CDISC standards. To date, TA standards have been developed for over 30 disease areas.

ADaMIG v1.2 & ADaM Integration

This webinar will highlight the changes in version 1.2 of the ADaM Implementation Guide, which is scheduled to be published this year. Changes include important clarifications to existing text, standard nomenclature for stratification variables within ADSL, and a recommended approach for bi-directional toxicity grades. We will also discuss the removal of PARQUAL, which had been included in the document when it went out for Public Review.

Controlled Terminology Updates for Q2 (Package 37 Update; Package 38 Public Review)

This webinar will include a description of the P37 publication, including changes that occurred post-public review, and the P38 public review package. Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets.

 

Panelists:

  • Erin Muhlbradt, Clincal/Biomedical Information Specialist, MSC
  • Chris Gemma, Project Manager, CDISC