SOCRA CCRP Actual Free Exam Questions & Community Discussion
In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?
Correct Answer: D
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A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard.
Before applying this change to all subjects, what must occur?
Before applying this change to all subjects, what must occur?
Correct Answer: D
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In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
Correct Answer: A
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An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
Correct Answer: C
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An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. Which of the following parties, if any, is the investigator required to notify?
Correct Answer: C
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During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
Correct Answer: C
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The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?
Correct Answer: D
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Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?
Correct Answer: B
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Upon completion of a study, the investigator should do which of the following?
Correct Answer: C
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In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?
Correct Answer: B
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