SOCRA CCRP Practice Exam

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When must a sponsor submit a brief report of investigation progress to FDA for drug trials?

  1. Within 60 days of anniversary date that IND went into effect

  2. Within 30 days of anniversary date that IND went into effect

  3. Within 90 days of the fiscal year end

  4. At the conclusion of every phase of the trial

The correct answer is: Within 60 days of anniversary date that IND went into effect

The correct answer is A because it is stated in FDA regulations that sponsors must submit a brief report of investigation progress within 60 days of the anniversary date that the investigational new drug (IND) went into effect. Option B is incorrect because it specifies a shorter timeline than what is stated in regulations. Option C is incorrect because it mentions the fiscal year end, which is not relevant to the submission timeline for IND progress reports. Option D is incorrect because it does not specify a specific timeline and simply states "at the conclusion of every phase," which could be interpreted as any time during the trial. Therefore, option A is the only correct answer as it aligns with FDA regulations regarding IND progress reports.

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