Typical Workflow in SAS Clinical Data Integration

Overview: Typical Workflow

The features and functionality provided by SAS Clinical Data Integration enables the following workflow:

Import a data standard and controlled terminology. (For more information, see Importing Data Standards Metadata and Importing Terminology Data Sets.
Create studies and submissions. (For more information, see Creating a Study or Submission.)
Create domains. (For more information, see Creating a Domain.)
Standardize and validate data. (For more information, see Assess CDISC SDTM Compliance and Assess ADaM Compliance.)
Analyze data standard use across studies and submissions. (For more information, see Analyzing Domain Use and Promoting a Domain to Be a Template.)

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 role. The following user definitions explain the typical owners and their tasks in the workflow.

Clinical 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.

For tasks that are typically performed by clinical administrators, see Data Standards Administration.

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.

For tasks that are typically performed by trial managers, see Studies and Submissions Management.

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.

For tasks that are typically performed by clinical programmers or data managers, see SDTM Domains.