Summary

This article will explain how to export or download Subject and Site/Study-related data.

Table of Contents

  • Options Prior to Exporting
  • Export Types

The Subject-related data export supports multiple formats: CDISC ODM, SAS XML, IBM SPSS SAV, and Excel. The Site and Study-related data support two formats: SAS XML and IBM SPSS SAV.

The Extract-All Study Data link is accessed from the Data Extraction menu.


Extract all subject CRF data or site and study type data by selecting Export All Study Data in the Data Extraction menu. Only users with Administrative permissions (user role with a hierarchy level of 200) are able to view this page.

 


After selecting Export All Study Data, you will have some options to select for the export and the export types.

Options Prior to Exporting:


Include Archived Records

Archived records are past versions of records over time as data changes were made and records were resaved by users.


Include Deleted Records

Records that have been deleted from the study can still be accessed in the exports


Include Draft Records

Draft records are non-final versions of a record. This depends on whether the study function of draft saving has been enabled.


Use Label as Header for Excel and CSV Export

This option will list the assigned field label as the column header, if available.


Separate Date into Year Month and Day columnsSplit Date Fields into 3 Parts

This option will take any date field and create three separate columns of data: "FIELDNAME_day," "FIELDNAME_month,"  and "FIELDNAME_year."

Select Site 

For Subject related exports, use the Select Site filter to run the export for All Sites or a specific site selected from the dropdown.


Version

It is necessary to select which version of the study to export. If multiple sites/subjects are on different versions, they will need to be exported separately. The reason exports are separated by version is due to the extensive study design changes that can be made from one version to the next. Combining versions into a single export would lead to inaccurate data.


Export Types:

CDISC ODM (Snapshot)

The CDISC ODM (Operational Data Model) XML is a Snapshot format that supports version 1.3 of the specification as published in http://www.cdisc.org. There are 3 options for the ODM export: Metadata Only export, the Data Only export, and Metadata and Data in one file export.


Metadata Only Export

The Metadata Only export defines events, forms, and questions that make up a study.  The metadata can be downloaded by clicking on the Click here to Export Metadata to ODM link.


Data Only Export

The Data Only export provides a data transport and storage mechanism for the actual clinical data as entered in the CRFs. The data can be downloaded by clicking on the Click Here to Export Data To ODM link.


Metadata and Data Export

The Metadata and Data Export option combines both the Metadata and Data in one ODM export file. The data can be downloaded by clicking the Click Here to Export Both Metadata and Data To ODM link.


SAS XML Export

The SAS XML (Xtensible Markup Language) format is used when you want to load the study data into SAS. SAS users will also want to use the XML MAP  so SAS does not try to automap data types in the XML file. If using a SAS universal viewer, the SAS XML file will not be read. A full version of SAS, on the other hand, is able to open and map SAS XML. 

To view the dataset without the full version of SAS software, SAS has an XML Mapping application as a free download that can be used to view the datasets. Just be aware, without a full licensed version of SAS software, the SAS XML can only be viewed using the mapping application. Navigate to the external SAS download page for this application.


XML Export

The XML export provides an XML document that can be used by other products that support or process XML Documents. It can also be used to create a SAS data set using SAS’s XML Engine with the help of an XML MAP file.  


XML MAP Export

The XML Map export is an XML document that provides the capability for a SAS program to read an XML file into a collection of SAS Data Sets. This XML MAP file only works with the XML File downloaded from XML format. The XML MAP file can be downloaded by clicking the Click Here to Export XML MAP link.


IBM SPSS Export

The IBM SPSS format provides a binary data file (sav format) that can be used by IBM’s SPSS (Statistical Package for the Social Sciences) program or GNUS PSPP (http://www.gnu.org/software/pspp/) program for statistical analysis. The exported file is a zipped collection of all the CRF’s in the study. The zipped SAV files can be downloaded by clicking the Click Here to Export to SPSS SAV link.


Excel

This downloads a single Excel file workbook with each dataset (form) included as a worksheet within.


CSV

This downloads a zip file that includes separate dataset files for every form in the study.


Clicking on any export link will start the export and display the progress in the Export Progress bar. In most cases, this should only take a few seconds. Once it's complete, the download will go immediately to your downloads folder or wherever you have set your computer to send downloads.


NOTE: Data is blank in data extracts.  You will not see NULL or any other alternative.


Background Download

When exports are pulled using the Background Download option, they are executed at Background Export Job screen and the user receives an email confirmation once the Download is complete.


Need more help?

Please visit the Datatrak Contact Information page.