5 Correct Answer: The minimum number of IRB members
Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?
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MEGA SOCRA CCRP EXAM CONTENT| 790 QUESTIONS (100
PAGES)| WITH COMPLETE SOLUTION
5 Correct Answer: The minimum number of IRB members
Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: In a
non-emergency situation, under which of the following conditions, if any, may subjects be
enrolled into a study prior to IRB/IEC approval?
The Sponsor Correct Answer: The responsibility for ensuring that the investigator understands a
clinical trial lies with:
A subject has been enrolled on a study and was randomized to the non-treatment arm. The
protocol outlines study procedures for all subjects to be performed within one week of
enrollment. Which of the following statements about this case is correct? Correct Answer: This
subject should undergo all study procedures as outlined in the protocol
A significant risk device is defined as an investigational device that is: Correct Answer: a.
Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of
a subject.
b. Purported or represented to be for a use in supporting or sustaining human life and presents a
potential risk to the health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or
otherwise preventing impairment of human health and presents a potential for serious risk to the
health, safety, or welfare of a subject.
With respect to IRB/IEC membership, both the FDA and the ICH require that Correct Answer:
At least one member's primary area of interest is in a nonscientific area
The rights, safety, and well-being of human subjects are protected Correct Answer: A purpose
of monitoring clinical trials is to verify that:
Which of the following is the proper way to make a correction to a CRF? Correct Answer: Add
the initials of the person making the change, the date of the change, and, if necessary, a brief
explanation of the change.
What details need to be documented in the subject source documentation when an Adverse Event
(AE) occurs? Select all that apply Correct Answer: A. The severity of the event
B. When the event occurred
C. Setting in which the event occurred
What is an Unexpected Adverse drug reaction? Correct Answer: A reaction that is not consistent
with the applicable product information
,The terms "serious" and "severe" are synonymous according to ICH. Correct Answer: FALSE
A serious adverse event is any untoward medical occurrence which at any dose is best described
by which of the following statements?
Select all that apply Correct Answer: A. Results in death
B. Is life-threatening
C. Is a congenital anomaly
. Which of the following options describes the term "severe" in regards to ICH? Correct Answer:
The Intensity of a specific event
Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after
participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's
Brochure as a possible side effect. Which of the following options best describes this situation?
Correct Answer: Serious Adverse Drug Reaction
A subject in your diabetes research study developed colon cancer, which the Investigator has
determined to be unrelated to the study. The subject is currently asymptomatic. This will be
considered a serious adverse event because it is life threatening. Is this a true or false statement?
Correct Answer: FALSE
In pre-market approval studies, all noxious and unintended responses to a medicinal product,
even possibly related to any dose, should be considered which of the following options? Correct
Answer: Adverse Drug Reaction
A subject has a suspected serious adverse drug reaction with the outcome of death. Per the ICH
E2A guideline, which are items that should be submitted to the Sponsor? Correct Answer: 1. A
de-identified autopsy report, if available
2. Cause of death, and a comment on its possible relationship to the suspected drug reaction
Two weeks after starting an investigational therapy, a subject is rushed to the hospital after
experiencing a heart attack. The subject is currently being treated in the Intensive Care Unit
(ICU). The ICU doctor has noticed that the subject was enrolled in the trial and has contacted the
trial Principal Investigator. Heart attack is not described in the Investigator's Brochure. What
actions must be taken by the Principal Investigator? Correct Answer: 1. Report to the Sponsor
per the protocol timelines for serious, unexpected events.
2. Report to the IRB/IEC per their event reporting requirements for serious, unexpected events.
What is the timeframe for "expedited" reporting of serious, fatal or life-threatening, unexpected
adverse drug reactions to regulatory authorities? Correct Answer: As soon as possible, but no
later than seven calendar days after first knowledge of the event
Adverse Drug Reaction (ADR) Example Correct Answer: Your third subject in a Phase III drug
trial calls to report that she has developed a rash on her chest 12 hours after taking her second
dose of the investigational study drug. She states that it itches and is slightly uncomfortable. She
tells you that she has never had a rash and this is totally unexpected. You know from the
,Investigator Drug Brochure that only 12% of the patients get a rash from this drug. Which of the
following options best describes this situation?
What is the purpose of the IRB/IEC? Correct Answer: Safeguard the rights, safety, and well-
being of all trial subjects
Who is responsible for designing the clinical trial protocol? Correct Answer: Sponsor
Informed Consent Process Correct Answer: The process by which a subject voluntarily confirms
his or her willingness to participate in a clinical trial is best described as which of the following
options?
The Monitor Correct Answer: Who is ultimately responsible for Source Data Verification or
SDV?
A. At least five members
B. At least one member whose primary interest is non-scientific
C. At least one member who is independent from the Institution/trial site Correct Answer: The
IRB/IEC should consist of a reasonable number of members, who collectively have the
qualifications and experience to review and evaluate the science, medical aspects, and ethics of
the proposed trial. It is recommended that the IRB/IEC should include which of the following
options?
Which of the following is NOT one of the required elements of an informed consent form?
Correct Answer: A listing of all site personnel who will be involved in the research
Name 3 of several required elements of an informed consent form Correct Answer: 1. The
purpose of the research
2. A description of benefits that may be reasonably expected from the research
3. A contact person for questions about the research
According to ICH E6, who must sign the Informed Consent Form or ICF? Correct Answer: The
person who conducted the informed consent discussion
The subject or the subject's legally acceptable representative
As per ICH E6 GCP, which groups of potential subjects could be defined as "vulnerable
subjects"? Correct Answer: Members of the armed forces
Patients with incurable diseases
Persons in nursing homes
As per ICH E6 GCP, patients with heart conditions alone are defined as "vulnerable subjects"?
Correct Answer: False
A subject, who has been 100% compliant thus far, has forgotten to bring her medication back to
the clinic for her regular visit. She reports that she has not missed any doses and has been fully
, compliant with the protocol. What is the most appropriate action for the investigator or clinical
research coordinator to take? Correct Answer: Document that the subject has forgotten to return
her medication in the source document and ask her to bring the medication back to the clinic as
soon as possible or during her next visit.
A study subject reports that he has been having headaches for years but they seem to have
become more frequent since starting the study drug. The principal investigator believes that the
headaches are not related to the study medication. How should the event be reported? Correct
Answer: Adverse event, since the headaches have become more frequent
You are in the role of Study Manager for the Sponsor. One of your monitors reports significant
noncompliance at a site. Which of the following options would be the first course of action for
you to implement? Correct Answer: Root Cause Analysis
If a sponsor's attempts to secure compliance have failed, and the monitoring/auditing identifies
serious and/or persistent noncompliance on the part of an investigator or institution, the sponsor
should implement which of the following actions? Correct Answer: Promptly notify the
regulatory authority(ies)
Terminate the investigator's/institution's participation in the trial
Which phase of clinical research has a primary objective to demonstrate or confirm therapeutic
benefit? Correct Answer: Phase 3
Which phase of clinical research is often called "Therapeutic Use." It begins after drug approval.
Correct Answer: Phase 4
The type of study that investigates human pharmacology and is the initial administration of the
investigational new drug in humans. Correct Answer: Phase 1
The main goal of which phase of drug development is to explore therapeutic efficacy in patients?
It is important during this phase to determine the dose and regimens that will be used for later
trials. Correct Answer: Phase 2
Characterization of a drug's absorption, distribution, metabolism, and excretion that continues
throughout the development plan is defined as what? Correct Answer: Pharmacokinetics
Which of the following is not a special population mentioned in ICH E8? Correct Answer:
Prisoners
According to ICH E8, which of the following are response variables that are chosen to assess the
drug's effects? Correct Answer: Study endpoints
True or False? The intention of ICH E8 is to describe internationally accepted principles and
practices in the conduct of both individual clinical trials and overall development strategy for
new medicinal products. Correct Answer: True
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