Title: Managing Custom Data Standards in SAS Clinical Data Integration
Abstract: SAS® Clinical Data Integration (CDI) is built on the idea of transforming source data into CDISC standard domains such as SDTM and ADaM. However, you can also define custom data standards to use within CDI. This paper describes several scenarios for using custom data standards, such as incorporating company-specific requirements, developing therapeutic area or compound level domains, and even using study-specific data standards. This paper also describes in detail how to set up the required data sets to define a custom data standard, register the custom data standard with SAS Clinical Standards Toolkit (CST), and import the custom data standard into SAS Clinical Data Integration. In addition, best practices are discussed for both managing the security of SAS Clinical Standards Toolkit Global Library that is central to the SAS Clinical Data Integration application and for the overall process of developing custom data standards. OVERVIEW OF USING DATA STANDARDS IN SAS CLINICAL DATA INTEGRATION There are numerous ways SAS Clinical Data Integration helps users implement CDISC data standards. SAS Clinical Data Integration is built using SAS Data Integration Studio as its foundation. Then SAS Clinical Standards Toolkit is integrated into it, which provides metadata about the CDISC data standards and controlled terminology, as well as tools to check compliance of study domains to the data standard. Within the user interface of SAS Clinical Data Integration, users can import data standards. These data standards come directly from SAS Clinical Standards Toolkit. There are several versions of SDTM, ADaM, and SEND data standards available for import. A data standard that has been imported into SAS Clinical Data Integration contains domain templates, which contain all of the metadata about each domain. This includes all of the columns possible for the domain and their label, length, and format. Each column also has its own metadata; such as whether it is Required, Expected, or Permissible, whether it is a key variable, its XML data type, and any associated controlled terminology codelist. Each domain also has metadata defined. This includes its structure, title and file name of its archive file (SAS v5 transport file), and its key variables. When a user creates a new Study in SAS Clinical Data Integration, they choose which data standard(s) they would like associated with the Study. Then, the user can create new Standard Domains within the study, where they choose which domains from the associated data standard(s) they would like to create. At the time they are created, these domains are metadata objects within SAS Clinical Data Integration and are an exact copy, including all metadata for the domains and their columns, of the domain templates from the data standard. From there, users create SAS Clinical Data Integration jobs to populate those domain instances with data by transforming the source data into the structure required by the domains. Another piece of the submission puzzle is the define.xml document that accompanies the submission. This document describes the study, all of the data sets being submitted, their structure, codelists used, computational algorithms, comments, value level metadata, and more. SAS Clinical Data Integration has a transformation that can create the define.xml using the metadata from the study, its domains, and the Controlled Terminology Package associated with the study.
Publication Year: 2014
Publication Date: 2014-01-01
Language: en
Type: article
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