Overview

ClinSpark supports data exports into SAS transport files (SAS XPT v5 and v8 formats) compatible with FDA reporting guidelines.

Opening SAS XPT Files

The SAS Transport File Format is an openly documented specification maintained by SAS. The files are intended to be opened with a viewer that has the intended purpose of handling SAS data sets.

SAS offers a free ‘universal’ viewer application for Windows users to open SAS transport files. Details about that application and user guides are available on their support site. There may be other applications available with the purpose of opening and viewing SAS data sets, such as (paid) plugins for Microsoft Excel or statistical software such as JMP.

Automatic characters conversion

With SAS transport files all character data are stored as ASCII, regardless of the operating system and XPT file format. ClinSpark natively supports UTF-8 characters in all data collection interfaces. For instance, Lab Data result might come into ClinSpark encoded with UTF-8 characters. In order to comply with the XPT standard while exporting data from ClinSpark, a conversion procedures is applied.

ClinSpark performs a UTF-8 Character conversion and normalizes all UTF-8 characters using NFD Unicode form. The normalization converts characters with diacritical marks, changes all letter case, decomposes ligatures, and converts half-width katakana characters to full-width characters. One part of that processing is to remove accents, which is language and character set specific. See NFD Unicode normalization form for a detailed specification.

The normalizer also decomposes the original characters into a combination of a base character and a diacritic sign (this could be multiple signs in different languages). á, é and í have the same sign: 0301 for marking the ˊ accent. Our normaliser will find all such diacritic codes and will replace them with an empty string.

Customer controlled characters conversion

In addition to an automatic conversion, ClinSpark allows customers to specify their own mapping rules. The following tables define “default” conversion rules:

Automatic character filtering

Once automatic conversion and customer defined conversion have taken place ClinSpark, performs some final filtering steps:

• strips out all non-ASCII characters

• erases all the ASCII control characters

• removes non-printable characters from Unicode

• removes leading and trailing whitespaces

Conversion Audit

In cases where a conversion has occurred, ClinSpark generates an audit log. The audit is captured in the log with naming based on the following rules:

where ${domainFileName} is a reporting data domain defined for each item during study design. The audit file is then included with the XPT file. See the following example for TransferData-XPT_${date}zip: