3. Exporting eCRFs

Exporting Data

eCRFs/Calendars > Biostat Console > Data Export tab

The Data Export tab is used to collect data for use in statistical research efforts. From the Data Export page, you can select data to be exported into Excel spreadsheets or files formatted for easier import into SAS.

By default, the Export Data page initially displays information for any form, in all categories and all states. The Form Status multi-select field at the upper right of the page allows you to filter the table (for example, to show Completed or Validated forms only). The Non-Empty Forms column shows the count of all forms that meet the filtered criteria.

The Export? column checkboxes are used to select the forms for which data is exported. You can also use the All, Non-Empty, or None links at the bottom right of the form rows to select and deselect forms.

Export Options section

At the bottom of the form listing are checkboxes that affect the output of the data that is exported, and can be useful to make the exported data files easier to use in other data analyzing systems.

Lab Exams as Columns

This checkbox allows you to display each lab exam as a distinct column in the export. When this option is selected, only the lab value appears; other form data is omitted.

Use Descriptions

When selected, Description values for the items are displayed in the export. When deselected, Code values are displayed.

Exclude Headers

When selected, column headers are not included in the output to Excel.

Use Variable Names

When selected, the variable name for the form field is used as the column header in the SAS export file. (The checkbox is selected by default when the Export Format is changed to SAS.)

Include Rows for Empty Forms

When selected, empty forms are included in the output. This allows you to see whether the form was missed or there were no data to enter into the form.

Export Format

Use this drop-down menu to select either SAS or Excel, before clicking Export.

Excel

Excel exports will be put into a ZIP file for download. Each form will be exported as a workbook with three worksheets. The first worksheet will consist of the Form data, the second worksheet will contain the Domain data, and the third worksheet will contain Format information for the data fields included on the form. If only one form is exported, the export file will not be zipped.

SAS

Forms exported in SAS format will be sent to a ZIP file with each form in a separate folder. Each form’s folder will contain five files:

• FormName.sas – a SAS program file containing form data
• FormName.txt – a text file containing form data
• ColumnNameKey.txt – a SAS/OnCore field name map
• Domains.txt – a text file containing domain data
• Format.txt – a text file containing formatting information

The .sas file and form data file can be imported directly into SAS. The other files are formatted as simple text with the fields delimited by tabs, so that they can be opened in other statistical software such as R.

Depending upon the form's format, the export may create more than one folder of files for each form. For example, a form that contains two grid sections will generate two a folder for each section, each containing the five files listed above. However, a form containing only one list section and one grid section will generate only a single folder.

Export

Once you choose an export format and click Export, OnCore displays a progress window. When the export is completed successfully, the file downloads and automatically appears.

In the Export File, Sequence Number, Initials, Form, Not Applicable, Phase, Segment, Cycle, Day, Visit Date, Form Status, Arm, and Level are all standard columns.

Following those fields, the Form data appears.

If the form has date fields, there is an additional column for each date field with an EXT suffix on the column name. Forms exported from the Biostat Console with Fuzzy dates appear as 01/01/YYYY with 'Year' in the dates's EXT column when the date is accurate to the year. Dates accurate to the month appear as MM/01/YYYY with 'Month' in the date's EXT column. Dates that are NOT fuzzy dates appear how they were entered with the exact day, month, and year.

The Follow-up and Demographics forms contain data from the Follow-Up and Demographics tabs in the Subject Console and do not contain any form data. The number of Non-Empty Forms for Follow-Up is equal to the number of subjects with an On Study Date whose current status is Off Treatment or On Follow Up.

The number of Non-Empty Forms for Demographics is equal to the number of subjects registered to the protocol.

If a form contains a field using the Toxicity domain, the export automatically includes a column for AE Category.