When the IMP needs to be dispensed, you will need to set the IMP Container to “Dispense” Status, associate it with a Study Cohort and create the links between the Subjects and the Doses. Doses can be created on the IMP Container details page. Once they have been created, they will need to be confirmed.

Here is how you create Doses:

1. Login to ClinSpark and navigate to the Pharmacy Management Home page for the desired Study.

2. Click the “Action” menu for the desired Container and select the “Show” option. You will be taken to the IMP Container details page.

3. Make sure the Container is in Dispense Status and the appropriate Cohort is associated. Click the Doses “Action” menu button and select “Add”. A new “Save Doses” screen will open.

4. Open

   

   On the “Save Doses” screen select the appropriate Cohort, Activity Plan, Segment and Timepoint information, then enter the Quantity per Subject that you wish to dispense. A list of Subjects in the Cohort will appear in the table at the bottom of the screen.

Open

5. You can use the Randomize option and select how many Subjects you wish to randomize OR you could simply tick the Subjects that you wish to assign Doses to in the “Eligible Cohort Assignments” table below.

1. 6. Click “Save” to apply your changes. The “Save Doses” screen will close. You will be prompted to print Dose labels (immediate packaging). You can also print the labels later.

The Doses you have created will appear on screen. Each Dose will have an individual “Action” menu.

Confirming Doses

Once the Doses are created, they can be confirmed by yourself or another user (Second Verify for Dispensing IMP). You can confirm one or more Doses at a time.

To confirm an individual Dose click on the Dose “Action” menu and select the “Confirm” action. Then enter your credentials to confirm the Dose.

To confirm several Doses at once, use the tickboxes to select the relevant unconfirmed Doses, or use the top tickbox to select all Doses. Then click the “Doses” table “Action” menu and select the “Confirm” action. Then enter your credentials to confirm the selected Doses.

The information about the user, who has confirmed the Doses will be displayed in the “Doses” table.

Each Dose can only be confirmed once.