FDA Regulatory requirement for submitting the SAS Datasets

FDA and SAS Technology

The FDA is defining standards for various types of electronic submissions to the agency. A transport format developed by SAS Institute has been adopted as an FDA standard for accepting and archiving data sets.

The Electronic Records; Electronic Signature Rule (21 CFR Part 11), or "the Esig rule," is the US law that provides FDA the authority to identify types of submissions that the agency will accept in electronic form. The Esig rule also states that persons should consult the agency for details on how to proceed with electronic submissions. Such details include method of transmission, media, file formats, and technical protocols. The FDA issues guidance documents to reduce the need to consult for details.

In January 1999, the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) issued a joint guidance on general considerations for electronic submissions, entitled Providing Regulatory Submissions in Electronic Format - General Considerations . The guidance describes the use of the SAS System XPORT format for electronic data sets.

The FDA plans to issue a series of guidance documents that will focus on specific submission types. The first of this series was issued in January 1999, when CDER issued a guidance on NDAs, entitled Providing Regulatory Submissions in Electronic Format - NDAs .

Format of Electronic Data submission


You should provide data subsets in certain formats. Currently, we are able to accept and archive datasets in SAS System XPORT transport format (Version 5 SAS transport file). In circumstances when data are moved directly to a database or special review tool, tagged ASCII file, specifically, standard generalized markup language (SGML) and extensible markup language (XML), may be the appropriate file format. At times, delimited ASCII files are also acceptable. See the individual guidance for the specific submission type for the appropriate dataset format.

1. SAS System XPORT Transport Format (Version 5 SAS Transport Format)

SAS XPORT transport format, also called Version 5 SAS transport format, is an open format published by the SAS Institute. The description of this SAS transport file format is in the public domain. Data can be translated to and from this SAS transport format to other commonly used formats without the use of programs from SAS Institute or any specific vendor.
You should follow the recommendations in this section to create SAS transport files that we can review and archive.
Version

In SAS, SAS XPORT transport files are created by PROC XCOPY in Version 5 of SAS software and by the XPORT engine in Version 6 and higher of SAS Software. We are unable to archive SAS Transport files processed by the CPORT engine.

You can find the record layout for SAS XPORT transport files in SAS technical support TS-140. This document and additional information about the SAS Transport file layout can be found on the SAS World Wide Web page at http://www.sas.com/fda-esub.

Transformation of Datasets

We use a variety of software tools to analyze the datasets. Stat/Transfer from Circle Systems and DBMS/copy from Conceptual Software Inc. , are two programs used to convert data to various formats used for analysis. SAS Viewer version 7 or higher is used to open SAS transport files directly.


Naming SAS Transport Files

1. All SAS transport files should use .xpt as the file extension.
2. Compression of SAS Transport Files
SAS transport files should not be compressed. There should be one transport file per dataset.

3. Content of Datasets and Organization

You should provide a single transport file for each dataset.
Many of the software tools used by the reviewers require datasets to be loaded into random access memory (RAM) prior to opening the file. Therefore, dataset files should be organized so that their size is generally less than 50 MB per file.

Datasets divided to meet the maximum size restrictions should contain the same variable presentation so they can be easily merged, joined, and concatenated.

The datasets should be accompanied by data definition tables that include metadata such as the variable name, a description of the variable, the type of variable (e.g. , number, character, date), and codes used in the dataset.

Variable names should be limited to 8 characters.
You should include a descriptive label up to 40 characters in the label header.

Further recommendations for content of SAS Transport files are provided in guidance for each specific submission type.
We recommend that you discuss the content of the datasets with the review division prior to submission.