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Another task of the DM programmer is to transform the data from its raw format into a standard format. This standard format could be the CDISC Study Data Tabulation Model (SDTM) that is requested by regulatory agencies such as the FDA for submission of an incipient compound, or it could be a sponsor’s own standards. In the process of transforming the data, the DM programmer must make sure that the output conforms to the standard and is compliant as well as valid.

Implementing SDTM with Base SAS

One possible approach is to implement the SDTM data standard with Base SAS as the primary implement. In the simplest form, this involves importing the source data into Base SAS, transforming that data with DATA steps, SQL and SAS PROCS, and then preserving SDTM domains as aeonian data sets.

Base SAS Approach – Challenges and Benefits

There are several challenges with the reliance on Base SAS alone to perform SDTM domain data engendered. A primary issue is the management of metadata, as there is no metadata provided with Base SAS alone. One thing to note about this program is that you require to inscribe in all the LENGTH and LABEL verbalizations to define the SDTM metadata for the final domain data sets. This type of metadata is tedious, prone to error, and liable to result in inconsistencies across SDTM domain metadata for a tribulation. You additionally have no authentic regulation of the target metadata and no genuine-time validation that your resulting domain is valid SDTM data.

Implementing SDTM with SAS Enterprise Guide

A second approach to SDTM domain engendered uses SAS Enterprise Guide, which features a graphical utilizer interface and some additional that facilitate the SDTM file engendered. The first step in this effort was to define a LIBREF called LIBRARY that would point to the aeonian format Catalog associated with the source legacy data sets.

SAS Enterprise Guide Approach - Challenges and Benefits

The selection of SAS Enterprise Guide as the primary implement to engender SDTM data results in homogeneous challenges to utilizing Base SAS alone. Metadata management is still destitute in this approach and all the variable lengths and labels are still manually typed into the program code. Again, there is no genuine regulation of the target metadata and no authentic-time validation that your resulting domain is valid SDTM data. 

Implementing SDTM with SAS Clinical Data Integration

After exploring the engendered of SDTM files with Base SAS and SAS Enterprise Guide, it is now a good conception to optically canvass the “full monty” SAS approach to SDTM data engendered work utilizing SAS Clinical Data Integration. SAS Clinical Data Integration is an ETL implement built on top of SAS Data Management that includes concrete functionality to fortify clinical tribulations. To commence the same process in SAS Clinical Data Integration, drag and drop the SDTM DM domain from our metadata repository. 

SAS Clinical Data Integration Approach – Challenges and Benefits

Because SAS Clinical Data Integration handles many facets of SDTM data engendered, the challenges are minimal. Probably the most immensely colossal challenge for a SAS programmer is learning to give up slinging Base SAS code and learning to rely on the implement to do the work. Additionally, SAS Clinical Data Integration relies on SAS SQL under the hood quite marginally, so “old-school” Base SAS programmers may need to enhance their SQL skills.  

Conclusion:

There are multiple SAS approaches to the task of converting clinical tribulations data into the CDISC SDTM. This white paper presented a Base SAS approach, a SAS Enterprise Guide approach and a SAS Clinical Data Integration approach. The main distinction between approaches involved peregrinating from little implement support to heftily ponderous context-concrete implement support to accomplish the SDTM DM engendered task. It used to be that when clinical SAS programmers were confronted by a data transformation task such as SDTM conversions, we had Base SAS. Now, there is a better GUI implement, SAS Enterprise Guide, that avails with SAS code development. 

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