Stratification Blocks

If you wish to track enrollment based treatment arm, or based on demographic factors such as age, sex, ethnicity, etc., you can do so by creating Stratification Blocks.

When creating the protocol shell, you must select Stratified Block in the Automated Sequence No. field in order for the Stratified tab to appear in the horizontal tool bar.

In PC Console > Main, a horizontal tab for Stratified now appears.

Click Update, Add, and then Choose File to upload blocks of sequence numbers based on the factors you wish to delineate.

For example, if a study plans to enroll five midage subjects, five seniors, and five young adults, you may upload a block of five sequence numbers for each group. When the clinic coordinator enrolls a subject on study, they will have the option to assign the subject to one of these groups, and the subject will be automatically assigned to the next sequence numbers available for that group.

The Stratified tab also shows a view of how many total sequence numbers are assigned each group, how many have been used, and how many are still available.

The clinic coordinator will receive a warning when there are only five sequence numbers left in a group, and they will not be allowed to enroll more subjects in a group if the sequence numbers are depleted. More can always be added after the study is open to enrollment.

Contact oncore@wustl.edu if you need help setting this up for your protocol.