This course provides an overview of the functionality of the SAS Clinical Data Integration solution and then focuses on the task of the clinical data standards administrator and the clinical study administrator users of the software that supports the work done by the clinical programmers. Methods used to import, modify, and augment the metadata that describes standard CDISC SDTM and ADaM data structure and content are taught. These are the standards that are used by the clinical programmers to create instances of CDISC standard data structures for clinical studies. Additionally, in support of the goal to facilitate consistency, methods to define a standard organization of study metadata content are shown. Also covered are methods to monitor the status of clinical data integration projects and to promote new domain structures created within clinical projects to customized standards available across the organization.

• import SAS-supplied definitions for CDISC SDTM and ADaM data structure and content standards into metadata
• customize clinical domain tables and columns
• monitor clinical projects
• promote new standards
• define default study content.

Who should attend

Formats available	Standard duration
Classroom:	1.0 day

Before attending this course, you should be able to

• be familiar with clinical studies
• have some knowledge of the process of preparing CDISC clinical study submissions.

This course addresses SAS Clinical Data Integration software.

• reviewing the purpose and functions of SAS Clinical Data Integration
• understanding the software components comprising SAS Clinical Data Integration
• overview of SAS Clinical Data Integration components in the SAS Data Integration Studio interface

• reviewing user roles for SAS Clinical Data Integration
• reviewing tasks of the clinical data standards administrator
• executing clinical data standards administration tasks
• importing standard domains, domain columns, and compliance check metadata
• customizing a standard domain
• analyzing domain usage and promotion of custom domains
• creating customized compliance checks
• importing controlled terminology

• identifying tasks of the clinical study administrator
• executing the clinical study administration tasks
• creating and modifying terminology packages
• creating default content
• creating a new clinical study

• defining change management
• establishing a change management environment
• creating a project repository