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This document will explain how to export or download all Subject and Site/Study-related form data collected within TrialKit.
Access and Properties
If permission has been granted, the “Extract All Study Data” option is accessed from the Data Export menu:
Field blinding is enforced in the data outputs, based on the user role executing the export.
If the user accessing the exports is a site level user, the date exported will only be for the site(s) they belong to, or a single site can be selected to export. This saves needing to filter out that site’s data across every data set.
The following screen of options is seen when exporting all data.
From this screen, choose which data to include in the exported file(s). Here is a description of each option:
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 the study function of draft saving having been enabled.
Include Administrative Site  Records
Check this to INCLUDE admin site data in export. Â This is good for testing and validation.
Split Date fields into 3 parts
This option will take any date field and create three separate columns of data with "FIELDNAME_day", "FIELDNAME_month", Â and "FIELDNAME_year"
Use Labels as Headers
This will use the reporting label for each field - defined in the form builder - in place of the default field name.
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 reflection of data.
Export Formats
Background versus Direct Download
These options will produce the same results. The only difference is how they get processed.
Direct Download will require the user to wait for the file to process while the status bar indicates progress. Once complete it will automatically download. Navigating away from the screen will stop the export.
The background option is helpful for larger data volumes to avoid waiting on the screen for the download to finish. You can return later on to the background exports screen to retrieve the file.
CDISC ODM
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 TrialKit: 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. Â 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.Â
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 fully 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. Â
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 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 CRFs 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.
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 the computer to place downloads.
Blank data is blank in data extracts. Â You will not see NULL or any other alternative.Â
A note about Date and Time formatting:
The format of dates and times is dependent on the preferences of the user who is executing the export. User preferences can be temporarily changed if needed to export data with dates in a different format.
File Repository Information
Files uploaded on forms can be separately exported from the file repository. The data exports will only contain the file name if the field type is a file upload field.
Background CSV exports will include a “doc_id” column to the right of the file upload column. This contains the system unique file ID that is also seen in the file repository, to help with identifying files.
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