Define kit dispensation logic

Clinical supply managers choose how to define the dispensation logic in a study. Kits can be dispensed based on the lowest kit number or by the lowest sequence number.

To learn more about kit dispensation, see Specify supply settings.

Kit dispensation by lowest kit number

Dispensing kits by the lowest sequence number can potentially lead to partial unblinding in a study if multiple kits are dispensed to a subject one at a time. For example, a site user could have a new patient who gets dispensed a kit from the same resupply order as another patient on the same treatment arm. In this situation, a site user may put together what treatment arm the patients are on.

Kit dispensation by lowest sequence number

The default dispensation method is to release kits by sequence number.

Sequence numbers are an efficient way to group a random assortment of kit numbers. Sequence numbers can be helpful when a depot user is pulling the investigational product with random kit numbers at a depot, when they are creating shipments. In turn, this allows a randomization and trial supply management system (RTSM) the ability to identify which kits should be shipped based on expiry and sequence number. Sequence numbers ultimately allow more flexibility to further randomize a list in order to protect the blind based on the dispensing schedule or overall complexity of a study design. To maintain study blindness in a study, clinical supply managers can change the dispensation protocol to dispense kits by the lowest expiration date and the lowest kit number.