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TreatmentUpdate243 Vol. 33, No. 5 December 2021Available online at www.catie.ca/treatmentupdateContentsI RESEARCH ON TREATMENTS FOR COVID19I RESEARCH ON TREATMENTS FOR COVID19A. Antiviral treatments

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What is safety and efficacy of?

Safety and efficacy refer to the assessment of a drug, treatment, or medical device to ensure it does not cause harm and provides the intended benefit to patients.

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Pharmaceutical companies, medical device manufacturers, and researchers conducting clinical trials are required to file safety and efficacy reports.

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To fill out safety and efficacy forms, collect clinical trial data, summarize results, and complete the required documentation as specified by regulatory authorities.

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The purpose is to ensure that products are safe for use and effective in treating or preventing the conditions they are intended for.

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Safety and efficacy reports must include trial designs, results, adverse events, dosage information, and demographic data of participants.

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