SOCRA Certified Clinical Research Professional (CCRP) - CCRP Exam Practice Test
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties andfunctions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?
Correct Answer: A
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On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. According to the CFR, what is the earliest date when the site may begin to destroy the study records?
Correct Answer: B
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An investigator reports a serious adverse event suspected to be drug-related. By CFR, the sponsor must notify FDA no later than:
Correct Answer: C
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The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?
Correct Answer: D
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Why would a Phase IV study be conducted?
Correct Answer: A
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In determining the classification of risk for a study involving a medical device, it is necessary to consider the:
Correct Answer: B
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The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
Correct Answer: C
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Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?
Correct Answer: B
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A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?
Correct Answer: D
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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: C
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