Requirements
- Drug/Device Shipment and Receipt Records
- Drug/Device Accountability Log
- Most recent version of Investigator Brochure or Device Manual
QIU Tips / Additional Information
If the drug/device shipment, receipt, and accountability are managed by research pharmacy, indicate this in a note-to-file.
Refer to the HUB for drug/device accountability logs.
The Investigator’s Brochure or Device Manual provides clinical and non-clinical data on an investigational new drug or device. Updated versions of the Investigator’s Brochure or Device Manual should be submitted to the IRB.
If the drug is marketed, a package insert is an appropriate alternative for the Investigator’s Brochure. For marketed devices, basic product information is an appropriate alternative for the Device Manual.