After a randomization has been set up on a study, the allocation table can be viewed. With the appropriate permissions in Role Security, this page is found under the Subject menu:
This following example shows the View Randomization Allocations interface that allows the user to decode the randomization file, and display all planned and assigned randomization allocations. If there is more than one randomization schedule being used in a study, the selector at the top of the page allows for switching between those schedules.
The Randomization Allocation data table on the View Randomization Allocations page, shown above, displays all planned and actual randomization allocations. The user can see the randomization file that was uploaded by viewing the first four columns of the Randomization Allocation data table (Please Note: This particular randomization scheme is returning a Subject Profile ID). The last three columns in the Randomization Allocation data table contain the actual allocations including the site, subject, and date of allocation.
When a user saves a form that was defined for a particular randomization, the system will find the next available slot based on the site and stratification(s). The system then claims that slot by assigning the user’s site, subject and date of allocation to that slot. The system also associates this randomization allocation to the subject's visit. This information can be used to enforce randomization arms using Conditional Actions.
The View Randomization Allocations page gives the user the ability to decode the randomization allocations. For each allocation that was imported for a given randomization, the user can enter text to be displayed whenever this allocation is shown in Clinical Studio. To decode a randomization, the user simply enters in the text for each allocation and presses the "Save" button below the last allocation text box. The decoded text will show in the Allocation column in the main data table.
The View Randomization Allocations page allows the user to view only randomizations that have been allocated. If a user has a large randomization table, the user can click the View Only Randomized Subjects link above the Randomization Allocation data table to view just those subjects that have been allocated. The user can then toggle back to view all randomizations by clicking the View All Subjects link.
At any time, by selecting the Export link located above the Randomization Allocations data table, the user can export the entire randomization table to Excel. This gives the user a permanent archive of exactly how the randomizations were allocated for the duration of the study. It is also a method for updating the file, where additional randomization slots can be added to an existing schedule. Note, if editing or adding to a schedule, only empty slots can be modified.
Below are all the same functions accessed via the mobile app:
This allows a user with the proper permissions to open the randomization table (shown above) and individually clear existing subjects from the randomization slots they exist in. For Example, a study may have a withdrawal which requires that allocation to be re-used by another subject.
Note, this action is not audited by the system, so it should only be used with an understanding of its impact on the study.
If you have permissions to unallocate subject randomizations, simply swipe left on the row (mobile app only) and tap on the button "unallocate" that appears.