Extract Data by form, or exportable data packs (EDPs) allow administrators to create data packages from case report forms and export them to a variety of formats and with additional information that may be needed. They hold specific form data that has been joined with Subject and Event data. It is an excellent way to take data from the forms and use it in other applications outside of Clinical Studio.

The ability to view this page is based on having access to data extraction in the role security settings, as determined by an Administrator. As of v4.5.6.b, Any study role with a hierarchy of less than 200 will only be able to view exports which have been configured and targeted to their role - assuming the role has access to data extraction. Administrators (role hierarchy of 200) are the only role which can configure new exports.





See the annotated numbers in the image below with descriptions below the image to learn how to configure new exports and export data packs which have been made available:





1. Select which form to create a data pack for. 

2.Export data types:

  • Decode choice fields - Replaces the coded value of choice type fields (radio fields and dropdowns/picklists) with the choice text.
  • Use label as header - Uses the reporting label as the column header rather than the field name for each field
  • Archived records - Includes all archived records as well as the final ones. An archived record is a past versions of the same record which was then saved again and replaced by a subsequent one - such as when data is changed and a form is re-saved. An "Archived" column will indicate which records are archived versions versus which ones are final.
  • Deleted records - Includes any deleted records in the export. A "Deleted" column will indicate which ones are a deleted status.
  • Draft records - Includes records saved in draft mode, if the study was set up to allow draft saving.
  • Include Admin site records - Includes Admin/testing data in the exports. This data comes from any Administrative type sites, as defined in the Site Manager. 

3. Related columns - Subject Fields and Visit/Event Fields:

  • Primary key (sub_id) - This is the database primary key that is assigned to the given subject. It is used as a PK->FK relationship between the Subject Fields and the Event Fields.
  • Profile ID - The subject's ID which is seen throughout the system. This can potentially be changed by users, but the sub_id cannot.
  • Treatment start date - The visit/event date from the subject registration form
  • Version - The version of the study where the record currently exists
  • Site - The study site where the record exists
  • Study - The name of the study defined in the Study Manager
  • Primary key (trans_id) - A unique key to each subject event and is used to establish a link between the event and the actual form and sub form data.
  • Event Date - The date key field that must be entered into each subject form.
  • Form status - The current state of each record. For example, saved 
  • Form Frozen - Indicates True if the record has been frozen
  • Interval - The name of the visit
  • Unscheduled ID - The name of the visit if its an unscheduled one
  • Randomization Allocation - This will only show as an option if the study is randomized. It can be used to display the allocation (Unblinding) for each record.

4. Targeted Roles - Dictates which user roles will have access to the data pack export when they open the same page. Only Administrator roles (hierarchy level of 200) are able to setup exports as described here and access all data. Other lower roles can only export what has been set up for them.

5. Export description - Brief description of what the export is intended for.

6. Save data pack - Saves the export into the table at the top of the page

7. Export data pack - Click this link to open the data pack and run the export (described in more detail below).

8. Edit data pack - Use this option to adjust any of the pre-defined parameters described in items 1-5.


Exporting Data

Once you have completed the Add New Data Pack form and saved the form, it will be added to the Current Data Packages data table. In that data table is an export link. When clicked, the data will be exported to the selected data format and downloaded to the client computer as shown in the figure.



Data Model Considerations - Understanding the data

The Clinical Studio data model can be described as a hierarchal relational data model. The following chart shows the hierarchy of subject data.




 





Clicking the Export link will load “Grid Views” of your Form data. You will see 1 or more “Grid View” depending on how the form is created.

The figure below shows the Subject Profile Form with two grid views.  The first “Grid View” displays the Main Form Data; the second “Grid View” displays the “Sub Form Table” data, which come from having a normalized table on the form.  Depending on how a form is created, it may have no sub form table or more than one sub form table.

 


Pick the format of the Data on the Grid Views to be exported and Click Export

There are currently three types of exports formats; Excel, SAS XML and SPSS SAV. Choose the format you would like the form data to be displayed in when you do the actual export. For Excel and SAS XML Format you will need to pick the format for each Grid View that you want to export. For SPSS SAV you will only need to pick that form on the main Grid View and it will include all the sub form table data in a zip file.

The figure below shows an example of exporting the Main Grid View in SAS XML Format.

 


Save the Exported Data Pack

A Save File Window will appear after clicking the Export Button. Click OK to Open or Save the File to your computer. The following figure shows how to save the Exported Data Package to your computer or device.