Can I determine what happens when the next randomization number is associated with a code for a kit type that is not in stock at a site?

Yes. You must determine this requirement when you create a randomization design, typically after consulting a standard operating procedure (SOP) at your organization.

If you allow sites to randomize when the required kit type is not in stock (sometimes known as forced randomization), you also must determine whether the randomization number that you skipped over is assigned to another subject.

When a site randomizes even though a required kit type is not in stock, information about the forced randomization appears in the Randomization List (Unblinded) report. The letter Y appears in the Restricted to Available Kits column.