ACRP ICH exam with correct solutions

ACRP ICH exam with correct /| /| /| /| /|




solutions

Who is responsible for providing the trial protocol - CORRECT
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ANSWERS ✔✔The Sponsor /| /|




Documents which individually and collectively permit evaluation of
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the conduct of a study and the quality of the data produced are
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called..? - CORRECT ANSWERS ✔✔Essential documents
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All information in original records and certified copies of original
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records of critical findings, observations, or other activities in a
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clinical trial necessary for the reconstruction and evaluation of the
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trial are called..? - CORRECT ANSWERS ✔✔Source Data
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One of the primary purposes of a Phase I study is to determine the
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metabolic and pharmacologic action of the drug in humans. -
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CORRECT ANSWERS ✔✔True /| /|




The purpose of the IRB/IEC is to project subject safety. - CORRECT
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ANSWERS ✔✔True /|




Who is ultimately responsible for SDV? - CORRECT ANSWERS
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✔✔The Monitor /|

, Most typical study, investigates human pharmacology. It is the
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initial administration of an investigational new drug into humans.
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It is most commonly done in healthy subjects. Which phase if
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this? - CORRECT ANSWERS ✔✔Phase I
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What is the minimum number of members on an IRB/IEC? -
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CORRECT ANSWERS ✔✔5 /| /|




The purpose of ICH-GCP is to standardize the design, conduct,
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recording and reporting of clinical trials. - CORRECT ANSWERS
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✔✔True


The purpose of the DSMB is to assess the progress of a clinical
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trial, the safety data, and the critical efficacy endpoints. -
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CORRECT ANSWERS ✔✔True /| /|




The process by which a subject voluntarily confirms his or her
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willingness to participate in a clinical trial is known as.. - CORRECT
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ANSWERS ✔✔Informed Consent /| /|




The Declaration of Helsinki was developed by... - CORRECT
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ANSWERS ✔✔The World Medical Association /| /| /| /|




Which phase determines therapeutic benefit and is usually done
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in a larger, specific population? - CORRECT ANSWERS ✔✔Phase III
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