The sponsor-investigator is responsible for maintaining adequate records of the disposition of the drug, including dates, quantity, and use by subjects. This is.
21 CFR Question 1: I am an IRB Coordinator with a question for a principal investigator. He submitted an IRB application involving an.
TITLE 21 --FOOD AND DRUGS CHAPTER I--FOOD AND DRUG - Investigator recordkeeping and record retention. § - Investigator reports. Subpart A--General Provisions · Subpart B--Investigational · CFR 312. · Subpart I.
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