SOCRA CFR study sets, IND Set test Questions with Correct Answers Graded A+

SOCRA CFR study sets, IND Set test Questions with Correct Answers Graded A+ 5-142 What records must be maintained by investigators for investigational drug supplies? 21 CFR 312.62 Records of drug disposition including dates, quantities, and use by study subjects. 5-150 How must an investigator store investigational drugs which are also controlled substances? 21 CFR 312.69 In a securely locked, substantially constructed cabinet or other enclosure with limited access to prevent theft or diversion of the substance into illegal channels of distribution. 5-152 Once an investigator has been disqualified by the FDA, he or she may never again receive investigational drug True or False? 21 CFR 312.70 False: The FDA may reinstate a disqualified investigator if the FDA Commissioner determines that the investigator presents adequate assurances that he or she will work in full compliance with applicable regulations