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ACRP ICH Exam Challenge (100% Solved)
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ACRP ICH Exam Challenge (100% Solved)
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ACRP ICH Exam Challenge (100% Solved)Who is responsible for providing the trial protocol - The Sponsor
Documents which individually and collectively permit evaluation of the conduct of a study
and the quality of the data produced are called..? - Essential documents
All information in original records and certified copies of original records of critical
findings, observations, or other activities in a clinical trial necessary for the reconstruction
and evaluation of the trial are called..? - Source Data
One of the primary purposes of a Phase I study is to determine the metabolic and
pharmacologic action of the drug in humans. - True
The purpose of the IRB/IEC is to project subject safety. - True
Who is ultimately responsible for SDV? - The Monitor
Most typical study, investigates human pharmacology. It is the initial administration of an
investigational new drug into humans. It is most commonly done in healthy subjects. Which
phase if this? - Phase I
What is the minimum number of members on an IRB/IEC? - 5
The purpose of ICH-GCP is to standardize the design, conduct, recording and reporting of
clinical trials. - True
The purpose of the DSMB is to assess the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. - True
The process by which a subject voluntarily confirms his or her willingness to participate in
a clinical trial is known as.. - Informed Consent
The Declaration of Helsinki was developed by... - The World Medical Association
Which phase determines therapeutic benefit and is usually done in a larger, specific
population? - Phase III
An individual, company, institution or organization which takes responsibility for the
initiation, management, and/or financing of a clinical trial is called the.... - Sponsor
The main goal of this phase of drug development is to explore therapeutic efficacy in
patients. It is important during this phase to determine the dose(s) and regimens that will
be used for later trials. - Phase II
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