SAS is software where in they can use it in their domain and it is comparatively easy to learn as SAS® is neither a menu-driven nor a command driven application. Rather it relies on user-written scripts or “programs” that are processed when requested to know what to do. Because it is a script-based application, the key to being successful using SAS is learning the rule and tricks of writing scripts.

• Can process large data set(s)

• Easy to cope with multiple variables

• Can track all the operations on the data set(s)

• Can generate systematic output

• Summary statistics

• Graphs

• Regression results


Clinical data is sensitive information that should be treated as a valuable asset as well as a regulated commodity. Not only can improper management of clinical data cause the invalidation of an entire clinical trial, but it may also result in strict remedies, including serious financial penalties, from the FDA.

At the time of this writing, the FDA has not issued revised CFR 21 Part 11 guidance. This indicates that the FDA is still struggling with the difficult issue of Part 11 requirements compliance for a clinical database. However, it is known that the FDA does request that all clinical DBMS prevent unauthorized access to data. This requires that data be password protected and allow updates only by authorized users of the clinical DBMS.

The FDA also requires maintenance of complete audit trails for clinical data. Both the entry and revision of clinical data is to be logged to indicate the user performing the action, the date and time of the action, as well as the reason for change of data.

These requirements and many others are all easy goals when working with the SAS System. In addition to being easy to use, SAS is also the choice of the FDA for receiving and reviewing clinical data. The FDA is still requesting SAS transport data sets as the standard for receiving electronically submitted data. At a minimum, each FDA reviewer is equipped with the SAS System Viewer.

Since the use of SAS is essential to clinical information management, keeping clinical data in SAS makes sense. SAS is the government and the industry standard for performing clinical analysis. Reporting is also effectively accomplished using SAS.

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