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During a monitoring visit, you notice that several study participants received an intervention that did not match their randomization assignment. The study procedures that were
During a monitoring visit, you notice that several study participants received an intervention that did not match their randomization assignment. The study procedures that were performed do not agree with the printed confirmation form showing the subject assignments generated by the randomization system. The coordinator explained that when there are multiple subjects ready for randomization at the same time, sometimes the paperwork gets mixed up. How would you address this? (List 2 strategies)
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