Device Accountability

Some sponsors do not send us devices to keep on-site, their case support person will bring the devices when they come for a procedure.

E.g. NECC

If that is the case, you do not need to do much for device accountability. Just make sure you capture the LOT number/ID of the devices used by grabbing a sticker off the packaging, or taking a picture of the device.

The sponsor will usually provide you with a Device Accountability Log to fill out. The "received" date will be the same as the "opened/used" date in this case.

Some sponsors will pre-ship us devices to store on-site.

When you receive devices, the sponsor will have you fill out a Device Accountability Log and scan to them. You need to go through all the devices received, check their LOT numbers/IDs and document that.

The devices will be stored in the device closet in the heart & vascular offices area, unless otherwise specified. You will have a key to access that space.

You will need to pull them out and bring them to the cath lab when there is a potential enrollment procedure. Depending on the study and what information you have on hand about the patient, you might be able to narrow down on a few sizes of devices to bring. If not, you might want to bring one of each size just in case.

Whenever a device is dispensed, update the Device Accountability Log.

Drug Products/Pharmarcy

If a study involves investigational drugs, they will be stored in the pharmacy and have a separate IP (Investigational Product) log that lives in the pharmacy.

You will need to contact the pharmacy to arrange to pick up the drug before any enrollment cases for those studies.

Feel free to ask Jenn/Penny/Tiffany for more information as they have a lot of experience dealing with drug-involved studies.