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Clinical Research Associate Review Questions & Answers

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Phase 1 clinical trials - ANSWER Involves testing a new drug on a small group of healthy individuals (20-80). To find out what a safe dosage is, if there are any side effects, and how the body reacts to drug. Helps to figure out the highest dose humans can take without serious side-effects. Phase 2 of Clinical Trials - ANSWER Drug is tested for effectiveness and further safety. on 100-300 patients with the disease over time period of one to three years Phase 3 of Clinical Trials - ANSWER Involves testing the drug on thousands of patients and comparing it to existing treatment. Often randomizes patients into two groups, one group gets new treatment and the other gets existing treatment. Investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.

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