SOCRA CCRP Practice Exam

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What should a sponsor focus on when monitoring for compliance according to 21 CFR 312.56?

  1. The financial status of the trial

  2. The progress of investigations under IND

  3. Social media presence of trial participants

  4. Marketing strategies for the drug

The correct answer is: The progress of investigations under IND

A sponsor should primarily focus on the progress of investigations under IND when monitoring for compliance according to 21 CFR 312.56. This is because 21 CFR 312.56 specifically refers to the sponsor's responsibilities related to the monitoring and reporting of the progress and results of their clinical investigations. Monitoring the financial status of the trial or the marketing strategies for the drug may also be important, but they are not the primary focus of compliance monitoring as outlined in 21 CFR 312.56. Similarly, monitoring the social media presence of trial participants is not mentioned in this regulation and would not be a relevant aspect of compliance monitoring.

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