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CITI Training - Good Clinical Practice Newest 2025/2026 Complete All Questions And Correct Detailed Answers (Verified Answers) |Already Graded A+||Brand New Version!!
In terms of explaining the probability of assignment to trial arms in consent forms, which is true? - ANSWER-ICH notes that it should be included, but does not specify how the information should be presented.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If
investigators are complying with ICH E6 guideline, they must: -
ANSWER-Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records
Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations? - ANSWER-The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy. 1 / 2
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The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? - ANSWER-Identification of study risks to determine which may safely be omitted from continual monitoring.
Conducting Investigator-Initiated Studies According to FDA Regulations and GCP - ANSWER-
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? - ANSWER-IND report
Who is responsible for making the initial risk determination for a device being used in a study? - ANSWER-The sponsor- investigator.
Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND? - ANSWER-The study is not intended to be reported to FDA to support a new indication or support a labeling change.
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