SOCRA CERTIFICATION & PRACTICE ACTUAL EXAMS COMBINED 400+ QUESTIONS WITH EXPERT CORRECT DETAILED SOLUTIONS WITH RATIONALES | ALREADY PASSED | Grade A+

SOCRA CERTIFICATION & PRACTICE ACTUAL EXAMS COMBINED 400+ QUESTIONS WITH EXPERT CORRECT DETAILED SOLUTIONS WITH RATIONALES | ALREADY PASSED | Grade A+ How long are IRB records required to be maintained after completion of a study? - ANSWER 3 years (and accessible!). FDA can shut it down if IRBs are not keeping records appropriately Are there a lot of required documentations and records by the IRB? - ANSWER Yes. Lots of written procedures, must keep copies of meeting minutes, copies of correspondance, research proposals etc. Everything needs to be documented! Does the FDA have the power to shut down, stop studies, etc if an IRB is not operating in compliance? - ANSWER Yes! Can full on disqualify if they repeatedly dont comply. When does a research drug need an IND? - ANSWER If it can't be legally marketed or shipped, it needs an IND. If you're hoping for a label change or a new indication for use, it needs an IND. When does a research drug NOT need an IND? - ANSWER It is already legally able to be marketed. Your research doesn't aim to change label or current use. If it doesn't increase risk, or go in unstudied populations etc. Do you need an IND for a placebo drug? - ANSWER NO Do you need an IND for a UNLABELED indication of an approved product? - ANSWER No, and this is confusing to me. Do investigational new drugs need to be clearly labeled as such? - ANSWER Yes Can sponsors charge for an investigational drug? - ANSWER Yes, but it has to be regulated and approved by the FDA. And they need to show proof that its efficacious. Also, the cost of the drug must be burdensome on the sponsor in order for them to charge for it. What are the three phases of investigational drug studies? Describe and provide average # of subjects. - ANSWER Phase 1 - initial introduction of IND into humans. Determine metabolism and pharmacologic actions, pharmacokinetics. 20-80 subjects. Phase 2 - Controlled clinical study to evaluate effectiveness for a particular indication. Determine short term side effects and risks. Several hundred subjects. Phase 3 - Gather additional information about safety and efficacy, needed to evaluate overall benefit-risk ratio. Hundreds to thousands of subjects. What does an Investigator's Brochure contain? - ANSWER Drug substance, formula, structural formula. summary of animal data, summary of any human data. Pharmacokinetics in animals/humans. Summary of safety and efficacy, risks and side effects (to the extent known) Is an IND application brief? - ANSWER No it needs a billion and one things, like a grant but way worse. Summarizing the state of the union on this drug across time and nations