Exam (elaborations) RAC Devices Exam Prep 2021 (EU) Questions With All Correct Answers Graded A+. 2 Exam (elaborations) RAC Study Guide With Complete Questions And Actual Answers. 3 Exam (elaborations) RAC DEVICES Practice Questions And Answers 100% Guaranteed Success. 4 Exam (elaborations) RAC ...
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Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...
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Add to cartWhich of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of sys...
What source should the regulatory professional consult to determine when a product's patent and exclusivity will expire? A. Federal Register B. The Orange Book C. Patent and Trademark Office D. Copyright Office - correct answer B. The Orange Book...
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Add to cartWhat source should the regulatory professional consult to determine when a product's patent and exclusivity will expire? A. Federal Register B. The Orange Book C. Patent and Trademark Office D. Copyright Office - correct answer B. The Orange Book...
30-day hold - correct answer (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. T...
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Add to cart30-day hold - correct answer (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. T...
AND and NOT - correct answer What Boolean operator(s) narrows a search? OR - correct answer What Boolean operator(s) broadens a search? Title, abstract, introduction, discussion, results, methods, lit...
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Add to cartAND and NOT - correct answer What Boolean operator(s) narrows a search? OR - correct answer What Boolean operator(s) broadens a search? Title, abstract, introduction, discussion, results, methods, lit...
A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented one-third of its subjects properly . What is the FIRST thing the company needs to do? A.Stop the entire study B. Inform FDA and ask for guidance C. Re-train...
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Add to cartA company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented one-third of its subjects properly . What is the FIRST thing the company needs to do? A.Stop the entire study B. Inform FDA and ask for guidance C. Re-train...
Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912...
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Add to cartAdministrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912...
Who is the European Medicines Agency (EMA) - correct answer an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the indiv...
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Add to cartWho is the European Medicines Agency (EMA) - correct answer an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the indiv...
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