Requirements

• Drug/Device shipment and receipt records
• Drug/Device Accountability Log
• Most recent version of Investigator's Brochure or Device Manual

QI 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 QI website for drug/device accountability logs:
• Drug Accountability Log:
http://www.partners.org/phsqi/QIWeb/logs/DRUG%20DISPENSING%20LOG_5.7.08.dot

• Device Accountability Log:

http://www.partners.org/phsqi/QIWeb/logs/DeviceLog.dot

 

• 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.