SOCRA CCRP Practice Exam

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What event triggers the requirement for a sponsor to submit a brief report of investigation progress to the FDA for drug trials?

The signing of the clinical trial agreement

The anniversary date that the IND went into effect

When a drug trial is approved and an Investigational New Drug application (IND) goes into effect, it is required for the sponsor to provide progress reports to the FDA. This requirement is triggered on the anniversary date that the IND went into effect, which is why option B is correct. Option A, the signing of the clinical trial agreement, may be a key milestone in the drug trial process, but it does not necessarily trigger the report requirement to the FDA. Option C, the enrollment of the first patient, is an important step in the trial progress, but it is not the trigger for the report requirement to the FDA. Option D, the completion of the trial, may seem like it would be the trigger for the report but it is not. The report is expected to be submitted throughout the trial process to keep the FDA informed of progress. Therefore, option B is the most accurate and specific trigger

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The enrollment of the first patient

The completion of the trial