Typical Workflow in SAS Clinical Data Integration

Overview

The features and functionality provided by SAS Clinical Data Integration enables the following workflow:
  1. Import a data standard and controlled terminology.
  2. Create studies and submissions (clinical components).
  3. Define domains.
  4. Standardize and validate data.
  5. Monitor the progress of the definition of clinical domains.
  6. Analyze data standard use across clinical components.

Workflow Owners

Typically, different people own different tasks in the workflow. However, ownership can vary depending on the company, and a person might perform tasks in more than one capacity. The following user definitions explain the typical owners and their tasks in the workflow.
Data standards administrator
defines and manages data standards. Analyzes how data standards are implemented by programmers. Data standards administrators can view trends about how a domain is used by programmers. These trends might identify a new column to add to a domain, or point to a custom domain that you should promote into the standards.
Trial manager
defines studies and submissions, defines authorization, and sets the defaults that programmers use when defining content. Setting defaults ensures that programmers use the correct version of the data standards.
Clinical programmer and data manager
creates standard and custom domains, writes jobs to extract and transform data into domains, and writes jobs to validate compliance of domains to a data standard.