Requirements

• Drug/Device shipment and receipt records
• Drug/Device Accountability Log
• Drug/Device Dispensing Log

FAQs

Q: How can the Principal Investigator ensure compliance with drug and/or device accountability requirements?

The Principal Investigator has the following responsibilities regarding investigational drugs and devices:

• Maintain records of investigational product delivery to the study site.

Include dates, quantities received, batch/serial numbers, and expiration dates.

• Maintain an inventory of the investigational product at the study site.

Inventory control records should be updated, signed, and dated by the PI in a timely manner.

• Record/track use of the investigational product by each subject.

Documentation should verify that dosing/device use was in accordance with the approved protocol. Maintain an accountability log that records when the subject(s) received the drug/device and the specific dosage/device the subject(s) received.

• Return/dispose of unused investigational product as specified by the sponsor. Maintain documentation of return/disposal.
• Store the investigational product.

The storage area should be locked/secure with access limited to approved study staff only. Drugs/devices should not be stored with standard clinical inventory.