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Certified Clinical Research Professional (CCRP)
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In determining the classification of risk for a study involving a medical device, it is necessary to consider the:
A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?
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?
Upon completion of a study, the investigator should do which of the following?
A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?
A company’s CEO wants to commercially promote a device under an IDE study. This plan:
Which of the following identifies content that should be included in a clinical research protocol?
According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?
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?
A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?