Enhanced Subject Data Extract and other reports

Data managers and statisticians can now extract more relevant subject data in the application. Moreover, other users at a sponsor and site staff can generate better standard reports in the application.

Details for data managers and statisticians

When it comes to the Subject Data Extract, here's what you will see new in the data that you extract:

• In the existing column called REPEATNUMBER, a value of 1 is displayed for lab forms. Additionally, this column will continue indicating the repeating form instance number.
• A new column called SREPEATID. This is a unique number representing the ID of each repeating form included within a two-section form instance.
• A new column called SREPEATNUMBER. This indicates a row's unique number for the repeating form table in a two-section form and a lab form.

Note:

The values for REPEATNUMBER and SREPEATNUMBER indicate different values for lab forms. The REPEATNUMBER value will always be 1 and the value for SREPEATNUMBER indicates the value that used to be displayed in the REPEATNUMBER column.

Additionally, you must know that data collected in the Questions Before the Table section of a two-section form and data collected in the Questions In the Table section is presented in a merged format within the extract, to provide you with a comprehensive view of the repeating form data for analysis. For a lab form, data from the Date of Collection and Fasting Status questions is also merged onto each row, for the same reasons.

Details for site users and other users at a sponsor

• When it comes to the Subject Data report, you must know that the existing Repeating Form Number column will display different types of data, depending on what type of form it relates to. For example, it can indicate the unique number of a repeating form instance in a two-section form or a row's unique number for every repeating form (whether it is located in a two-section form or not).
• The Subject Queries report also indicates the instance number of a repeating form to provide more clarity for queries raised in a two-section form.
• The Randomization (Unblinded) List report can now be filtered by historical or current data in the study and it includes a new column that indicates the site, country, or region when a study is blocked.
• Lastly, the Subject Visits report (for both the Blinded and the Unblinded version) can now be filtered by active subjects or all subjects within your study.

Already working in a live study?

If you're already working in a live study, you must know that - as soon as the upgrade for this release is complete - you will see the new reporting and data extraction enhancements in the standard reports and the Subject Data Extract, respectively.