Investigational Medicinal Product (IMP)

On the Study-specific Pharmacy Management Home page, you can add one or more Investigational Medicinal Products (IMPs). These are virtual representations of the actual IMPs in your Pharmacy.

Each IMP will have a “general details” section about them. For each IMP you will be able to add the following information:

Name of the IMP - Name / Compound / API.
Receipt Date and Time - this is the time and date of when the IMP was created in ClinSpark Pharmacy. The field is generated by the system.
Lot/Batch Number of the IMP.
Quantity - enter the number of units received.
Product Units - enter the form of the IMP (tablets, capsules, vials, powders, etc.).
Default Dose Quantity (optional) - provide the default Dose Quantity per Subject per Dose.
Contents (optional) - provide any description of the contents of the received IMP.
Dispensation Notes (optional) - provide instructions for administration of the IMP, such as regimen, fasted conditions, etc.
Storage Notes (optional) - provide instructions for storage of IMP, such as environment, temperature, etc.
Confirmation details (optional) - this field will be populated by the system with the user details of the user, who performs the “Confirm” action on the newly received IMP, as well as the date and time, when the Confirm action occurred.
Expiration Notes (optional) - provide any expiration information that may be useful.
Expiration Date (optional) - enter an expiry date for the IMP. This date can be partial, for example Month and Year only.

The above information can then be used on labels, in reports and in the Pharmacy Dashboard component.

The IMP general details can be edited, deleted, confirmed, using the IMP “Action” menu. An audit trail of all actions is available.

The IMP will always be in one or more virtual Containers, until it is administered. The information about the Containers associated with the IMP will be displayed just below the IMP general details table.