ACRP-CP Exam
Study online at https://quizlet.com/_eqj5o2
In any trial, what should be the main
The welfare of the subjects
concern of the physician?
The world medical association (WMA)
ethical principles for medical research The Declaration of Helsinki
involving human subjects is called:
The process by which a subject volun-
tarily confirms his or her willingness to Informed Consent of Trial Subjects
participate in a clinical trial is known as:
The scientific tenability of the trial,
the subject-selection procedure, and the
What does the IRB/IEC evaluate?
rights, safety, and well being of the sub-
jects participating in the trial
Which of the following documents is the
All applicable laws and regulations,
investigator obliged to comply with dur-
ICH-GCP, and the trial protocol
ing the trial?
To review the protocol, to review the
What is the purpose of the initiation visit? blank case report forms (CRFs), and to
review standard procedures
Who is ultimately responsible for Source
The monitor
Data Verification (SDV)?
Every research study involving human
subjects must be registered in a publicly
True
accessible database before recruitment
of the first subject (T/F).
The Declaration of Helsinki was devel-
the WMA
oped by:
This phase determines therapeutic ben-
efit and is usually done in larger, specific Phase 3
population:
Therapeutic use & begins after drug ap-
Phase 4
proval.
A sponsor can be defined as... Phase 1
Mission statement of the ICH
, ACRP-CP Exam
Study online at https://quizlet.com/_eqj5o2
Providing a unified standard for Europe,
US, and Japan to facilitate the accep-
tance of clinical trials is the..
Any individual member of the clinical tri-
al team designated and supervised by
A sub-investigator can be defined as.. the investigator of a trial site to perform
clinical trial related procedures and/or to
make important trial related decisions
1. Clinical trials should be conducted in
accordance with the ethical principles
that have their origin in the DoH and that
are consistent with GCP and the applic-
able regulatory requirement(s)
2. Before a trial is initiated, foresee-
able risks and inconveniences should be
weighted against the anticipated benefit
for the individual trial subject and society.
According to the principles of ICH GCP... A trial should be initiated and continued
only if the anticipated benefits justify the
risks.
3. The available nonclinical and clinical
info on an investigational product should
be adequate to support the proposed
clinical trial
4. Clinical trials should be scientifically
sound, and described in a clear, detailed
protocol
All info in original records and certified
copies of original records of critical find-
Source data are.. ings, observations, or other activities in a
clinical trial necessary for the reconstruc-
tion and evaluation of the trial
What is the purpose of the IRB/IEC? To protect subject safety
Who is responsible for providing the trial
The sponsor
protocol?
What does DSMB stand for? Data and Safety Monitoring Board
Study online at https://quizlet.com/_eqj5o2
In any trial, what should be the main
The welfare of the subjects
concern of the physician?
The world medical association (WMA)
ethical principles for medical research The Declaration of Helsinki
involving human subjects is called:
The process by which a subject volun-
tarily confirms his or her willingness to Informed Consent of Trial Subjects
participate in a clinical trial is known as:
The scientific tenability of the trial,
the subject-selection procedure, and the
What does the IRB/IEC evaluate?
rights, safety, and well being of the sub-
jects participating in the trial
Which of the following documents is the
All applicable laws and regulations,
investigator obliged to comply with dur-
ICH-GCP, and the trial protocol
ing the trial?
To review the protocol, to review the
What is the purpose of the initiation visit? blank case report forms (CRFs), and to
review standard procedures
Who is ultimately responsible for Source
The monitor
Data Verification (SDV)?
Every research study involving human
subjects must be registered in a publicly
True
accessible database before recruitment
of the first subject (T/F).
The Declaration of Helsinki was devel-
the WMA
oped by:
This phase determines therapeutic ben-
efit and is usually done in larger, specific Phase 3
population:
Therapeutic use & begins after drug ap-
Phase 4
proval.
A sponsor can be defined as... Phase 1
Mission statement of the ICH
, ACRP-CP Exam
Study online at https://quizlet.com/_eqj5o2
Providing a unified standard for Europe,
US, and Japan to facilitate the accep-
tance of clinical trials is the..
Any individual member of the clinical tri-
al team designated and supervised by
A sub-investigator can be defined as.. the investigator of a trial site to perform
clinical trial related procedures and/or to
make important trial related decisions
1. Clinical trials should be conducted in
accordance with the ethical principles
that have their origin in the DoH and that
are consistent with GCP and the applic-
able regulatory requirement(s)
2. Before a trial is initiated, foresee-
able risks and inconveniences should be
weighted against the anticipated benefit
for the individual trial subject and society.
According to the principles of ICH GCP... A trial should be initiated and continued
only if the anticipated benefits justify the
risks.
3. The available nonclinical and clinical
info on an investigational product should
be adequate to support the proposed
clinical trial
4. Clinical trials should be scientifically
sound, and described in a clear, detailed
protocol
All info in original records and certified
copies of original records of critical find-
Source data are.. ings, observations, or other activities in a
clinical trial necessary for the reconstruc-
tion and evaluation of the trial
What is the purpose of the IRB/IEC? To protect subject safety
Who is responsible for providing the trial
The sponsor
protocol?
What does DSMB stand for? Data and Safety Monitoring Board
