Export Data Packages
Exportable Data Packages (EDPs) allow administrators to create data packages from case report forms and export them to a variety of formats. 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.
To access the EDP application, hover the mouse over the Data Extraction Menu and click the “Extract Data By Form…” link.
This opens the Exportable Data Packages application. The figure below displays the Exportable Data Packages application main screen.
The Clinical Studio data model can be described as a hierarchal relational data model. The following chart shows the hierarchy of subject data.
Explanation of the checkboxes:
The “Decode Field Choices” checkbox allows a user to select field choice text to display in the report in place of the field choice values defined in the form.
Use Label as Header (as opposed to field name)
The “Use Label as Header” checkbox allows a user to define the field name’s related field Label as the Header in the Exportable Data Pack.
At the top of the hierarchy is the subject profile data. That data contains a variety of fields that are directly related to the subject and are required of all subjects. This includes the following fields which can be selected when creating a data pack:
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.
This is the Profile ID assigned when the subject was registered (enrolled) in Clinical Studio.
This is the Enrollment date assigned when the subject was registered (enrolled) in Clinical Studio.
This is the date the Informed Consent agreement was signed. It too is entered when registering (enrolling) a subject in Clinical Studio.
This is the date the treatment starts. All dates from baseline to follow up are calculated using this date. It is entered when registering (enrolling) the subject.
No subject records are ever deleted. Instead a delete flag is stored along with the record. This flag is a Boolean value and if true, the subject record has been deleted.
This is the Site ID to which the subject belongs. This is the Primary Key from the site table.
The next level in the hierarchy is the subject event. An event can be a visit, event or subject transaction such as Demographics Form, Follow Up Form, Adverse Event or Medications Log Form. This table is used as an index to access and categorize the various forms that make up the subject record. It stores very important information that can be selected when creating the data pack.
The primary key is used to assign 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.
The event date is the date key field that must be entered into each subject form.
The Form Status describes where the record is in the process of entry. It can contain errors, monitor messages or be locked.
No events are ever deleted. This flag tells the system that the event is no longer accessible.
The system places a timestamp on each event when the record is originally created.
The system stamps the user that created the event. It does this by storing the user’s primary key identifier in the event record.
The event may belong to a fixed scheduled visit interval. If this is the case, the interval primary key ID is stored here.
If the event belongs to a variable visit interval, the primary key of the variable visit is stored here.
This is the code of the Randomization Allocation assigned to the subject when they were registered (enrolled).
The next level in the hierarchy contains the subject event forms. These are linked by the trans_id PK/FK relationship established at the event level. All main form subject data are stored in these tables with the column names being the same as the field name defined when the form was created.
All sub form data is related to both the transaction and the main form. Each sub form is assigned an ID; that ID is used when creating the sub form export table. It also contains the trans_id of the related subject event.
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.
Adding a New Data Package
To add a new data package:
1) Click the Form Dropdown list and select the desired form
2) Check the items to be included in the data pack
3) Add a description for the data pack (optional)
4) Click on Save Data pack
The figure below shows an example of adding a new data package for Subject Registration
All new added data packages will be displayed in the Current Data Packages
Exporting Data Packages
To export the Data Package, click the Export Link for the Data Package Configuration you want to export as shown in the following figure.
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. 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.