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21 cfr 312.62

21 cfr 312.62

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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21 cfr 312.62 The monitor insists that this is not compliant and that I should "hand write" every AE on a piece 21 cfr 312.62 paper and use this to have the PI determine the various classifications. Skip to Common Links. Skip to Common Links. Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following:. Behavioral intervention studies G. Note: If you need help accessing information in different file formats, see.