Versions Compared

Old Version 67

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 68

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

Guidance in this section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data. Guidance is focused focuses on implementation of standards for use cases inherent to studies of tobacco products . Use cases selected which are comprised of concepts identified by one or more stakeholders as important in the context of tobacco product studies and are:.


Metadataspec
Use Case Description
Product Description

Data used to characterize a product.

Trial DesignData which describes the overall plan and design of a study.
NonclinicalData from in vitro and in vivo nonclinical studies.
Product Impact on Individual HealthData used to assess the impact on of a product on individuals.  
Product Impact on Population HealthData used to assess the impact of a product on a population of individuals.

...