FREE SOCRA Knowledge Questions and Answers

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Which of the following is a disclosure of financial interests form?

Correct! Wrong!

The form ___ is used for investigational new drugs (or IND)

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Which of the following is 21 CFR 56.106 Subpart B?

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What is 21 CFR 50.27?

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_________ means the party who submits a marketing application to FDA for approval of a drug device or biologic product.

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The responsibility for ensuring that the investigator understands a clinical trial lies with which individual/or organization?

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What is the minimum number of IRB members?

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In a non-emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval?

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A purpose of monitoring clinical trials is to verify that:

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Which of the following is the proper way to make a correction to a CRF?

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The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.

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