Page | 1
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ACRP ICH Flashcards Challenge Questions
with Detailed Verified Answers (100%
Correct Answers) /Already Graded A+
Who is responsible for providing the trial protocol
Ans: The Sponsor
Documents which individually and collectively permit evaluation of the
conduct of a study and the quality of the data produced are called..?
Ans: 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..?
Ans: 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.
Ans: True
The purpose of the IRB/IEC is to project subject safety.
Ans: True
Who is ultimately responsible for SDV?
, Page | 2
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Ans: 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?
Ans: Phase I
What is the minimum number of members on an IRB/IEC?
Ans: 5
The purpose of ICH-GCP is to standardize the design, conduct, recording
and reporting of clinical trials.
Ans: True
The purpose of the DSMB is to assess the progress of a clinical trial, the
safety data, and the critical efficacy endpoints.
Ans: True
The process by which a subject voluntarily confirms his or her willingness to
participate in a clinical trial is known as..
Ans: Informed Consent
The Declaration of Helsinki was developed by...
Ans: The World Medical Association
Click here for more: Scholarsnexus - Stuvia US
ACRP ICH Flashcards Challenge Questions
with Detailed Verified Answers (100%
Correct Answers) /Already Graded A+
Who is responsible for providing the trial protocol
Ans: The Sponsor
Documents which individually and collectively permit evaluation of the
conduct of a study and the quality of the data produced are called..?
Ans: 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..?
Ans: 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.
Ans: True
The purpose of the IRB/IEC is to project subject safety.
Ans: True
Who is ultimately responsible for SDV?
, Page | 2
Click here for more: Scholarsnexus - Stuvia US
Ans: 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?
Ans: Phase I
What is the minimum number of members on an IRB/IEC?
Ans: 5
The purpose of ICH-GCP is to standardize the design, conduct, recording
and reporting of clinical trials.
Ans: True
The purpose of the DSMB is to assess the progress of a clinical trial, the
safety data, and the critical efficacy endpoints.
Ans: True
The process by which a subject voluntarily confirms his or her willingness to
participate in a clinical trial is known as..
Ans: Informed Consent
The Declaration of Helsinki was developed by...
Ans: The World Medical Association
