Define kits that can only be dispensed by a pharmacist or unblinded site user
Study designers can now define kits with an Unblinded Pharmacist distribution type. These are kits that can only be dispensed by an pharmacist or unblinded site user to subjects in the study.
What are the benefits?
For example, if you're designing a double-blinded study, perhaps one where investigational products need to be reconstituted by a pharmacist before being consumed by subjects, then this feature will help you.
Unblinded Pharmacist kits that can only be dispensed by a pharmacist or unblinded site user increase the study's efficacy and ensure the study's blind.
Details for user administrators
Your workflow hasn't changed. However, there is a new role that you need to be aware of.
The following new role allows users to dispense and monitor kits that can only be dispensed by an Unblinded Pharmacist.
Table 19-4 New role for viewing and managing kits that can only be dispensed by an Unblinded Pharmacist
| New role | Tasks that users with this role can perform | Users that should get this role |
|---|---|---|
|
View Unblinded Pharmacist kits in study |
Monitor, verify, or dispense Unblinded Pharmacist kits to subjects |
Typically, you assign this role along with the following other roles in the system, to make sure these users can monitor and dispense Unblinded Pharmacist kits:
|
Details for study designers
On the Kits tab, you can now define kit types using Unblinded Pharmacist as an option for their distribution type. When a kit is of the Unblinded Pharmacist distribution type, unblinded site users or pharmacists can see the kit's number and description. Blinded site users can't see the kits in the system.
Details for blinded site users
For Unblinded Pharmacist kits, you'll receive appropriate instructions to reach out to the pharmacist or unblinded site user in your study, so they can dispense the kits. If during the same visit, there are blinded kits and unblinded kits that can only be dispensed by a pharmacist or unblinded site user, you can only dispense the blinded kits to the subject.
After the dispensation is done, you'll receive a notification that contains information about the blinded kits you dispensed and another notice to see your pharmacist for the kits that only they can prepare and dispense to subjects.
Details for pharmacists or unblinded site users
When it comes to your workflow, you will now receive a notification that indicates the exact kits that you need to prepare and dispense to subjects in a study. Additionally, with the right role, you're able to see and dispense unblinded kits in the system.
Details for unblinded Clinical Research Associates
When it comes to your workflow, with the right role, you'll be able to monitor and review Unblinded Pharmacist kits in the system.
Details for clinical supply managers and unblinded depot users
When it comes to your workflow, nothing has changed. You can see all kit types within the system, as well as manage them.
Already working in a live study?
As soon as the upgrade is done, study designers can design new kits with an Unblinded Pharmacist type of distribution. Only newly created kits can be designed as Unblinded Pharmacist kits. After the study version is updated, pharmacists or unblinded site users can then prepare and dispense those kits, as long as the kits are available in the live study.
Parent topic: Randomization and supplies