This document will explain how to export or download Subject and Site/Study related data from Clinical Studio. The Subject related data export supports multiple formats: CDISC ODM, SAS XML, IBM SPSS SAV and Excel. The Site and Study related data supports two formats: SAS XML and IBM SPSS SAV.
The Extract All Study Data… link is accessed from the Data Extraction menu as shown in the figure below. Please note blank data is blank in data extracts. You will not see NULL or any other alternative.
Extract all subject CRF data or site and study type data using the option highlighted below in the Data Extraction menu.
Options to select 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 which 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 the study function of draft saving having been enabled.
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 reflection of data.
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 in Clinical Studio: 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 as shown in the figure below.
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 as shown in the figure below.
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 as shown in the figure below.
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 (discussed below) 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.
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.
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 XMLMAP file only works with the XML File downloaded from Clinical Studio’s XML format. The XML Map file can be downloaded by clicking the Click Here to Export XML MAP link as shown in the figure below.
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 as shown in the figure below.
This downloads a single Excel file workbook with each dataset (form) included as a worksheet within.
This downloads a zip file which 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 its complete, the download will go immediately to your downloads folder or wherever you have set the computer to place downloads.