Dispense kits
When completing a dispensation visit of any type, you must dispense the kits indicated in the system. This applies to both investigational product and devices. Other related tasks may be necessary, depending on your study design.
- Complete a randomization or dispensation visit
During a site visit, you collect data as required using the forms associated with the visit. You may also randomize a subject or dispense a kit as part of the visit. To randomize or dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject. - Complete a dispensation visit with dose changes
You must complete all required fields to be able to perform dose changes for a subject during a dispensation visit. To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject. This procedure applies to rollover studies, as well. - Complete a dispensation visit for devices
You must complete all required fields to be able to dispense devices to a subject during a dispensation visit. To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject. This procedure applies to rollover studies, as well. - Complete an unscheduled dispensation visit
During an unscheduled visit, you can dispense kits containing an investigational product, Unblinded Pharmacist kits, devices, perform dose changes or confirm the dispensation of kits, but you can't randomize subjects. To dispense, the subject must be screened and active. You cannot dispense to a withdrawn subject. - Perform a partial dispensation
Perform a partial dispensation to complete a visit when there are not enough kits available at the site to dispense. Partial dispensation is only available when a visit requires to dispense multiple kits of the same type and you have at least one kit available of each kit type that must be dispensed. - Pause dispensation by placing a dose hold
As a blinded site user or a pharmacist, you have the option of pausing dispensation during a scheduled or unscheduled dispensation visit to ensure a subject's safety. - View dispensed kit numbers and dosing instructions
You can always get a reminder if you've forgotten the kit numbers or need to review the dosing instructions one more time. This procedure also applies to rollover studies. - Confirm dispensation of kits
If confirmation of dispensed kits is enabled in your study, then this task can be part of your workflow. You can confirm dispensation of any type of kit: kits for investigational products, kits used to change doses for a subject, reusable kits or devices. - Conserve and re-dispense kits
Before conserving and re-dispensing kits, you need to determine whether the subject has any reusable kits. You can conserve and re-dispense these reusable kits during unscheduled visits, as well. - Conserve and re-dispense kits during a titration visit
You can also conserve and re-dispense reusable kits for a visit when you have to perform dose changes for subjects. - Dispense kits after a titration error
Maybe you tried to change the dose for one of the subjects in your study but it seemed like titration wasn't available. This could have happened because not enough time had passed after the last titration. If you don't know the minimum time between titrations, contact your Clinical Research Associate (CRA) or medical monitor. After enough time has passed, you can follow these steps to dispense kits. - Dispense a replacement kit (for lost, damaged, or not dispensed kits)
Replace a kit if it was dispensed in the system but never given to the subject, or if it was lost or damaged.
Parent topic: Receive and manage kits