Handling of investigational products (like a pro?)

Which of the following is an IMP ?

• New drug XYZ used as interventional drug to treat hypertension

• Placebo used as comparator in a trial

• Normal saline supplied by sponsor to dilute drug XYZ

• Blood pressure machine provided by sponsor to measure participant's blood pressure

Which of the following is true about RTSM?

• RTSM= randomisation, time and supply management

• RTSM can only be used to do randomisation

• RTSM can trigger IP shipment automatically when stock level is below certain threshold.

What is the first thing that you should do when you open a shipment box containing IP?

• Press STOP at the temperature monitoring device

• Check all IP in the shipment box to make sure that all the details are correct according to packing list

• Acknowledge receipt of the shipment in RTSM

Which of the following worksheet is used to keep track of each IP?

• IP accountability log

• IP temperature monitoring form

• IP packing list

• Extemporaneous worksheet

You are handling an IP which is a new vaccine in pre-filled syringes. Which of the following can be discarded after administration?

• Empty syringes after administration

• Empty box/ packaging of the IP

• Used needles

• Used swabs