Free CCRP Questions for SOCRA Certified Clinical Research Professional (CCRP) CCRP Exam as PDF & Practice Test Engine
A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. Where can the sub-investigator find a description of the unblinding procedure?
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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A sponsor became aware of a new serious adverse event related to a drug. Who must be notified in addition to FDA?
Correct Answer: C
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In accordance with the ICH GCP Guideline, who is responsible for ensuring that all study site personnel working on a clinical trial are qualified to conduct the trial?
Correct Answer: A
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In accordance with the Belmont Report, obtaining voluntary informed consent from subjects prior to enrolling them in a clinical trial is an example of which of the following ethical principles?
Correct Answer: B
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According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
Correct Answer: C
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In accordance with the CFR, which of the following statements regarding the informed consent document is correct?
Correct Answer: B
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A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?
Correct Answer: A
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A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?
Correct Answer: A
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