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Sponsors must file a CTA-A when the proposed changes to the protocol:
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affect the selection, the criteria for selection, monitoring, or dismissal of
a clinical trial subject
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affect the evaluation of the clinical efficacy of the drug
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alter the risk to health of a clinical trial subject
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affect the safety evaluation of the drug; or
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extend the duration of the clinical trial
Amendments are also subject to a 30-day default review.
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