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acrp ccra > ACRP Exam Prep questions > Flashcards

ACRP Exam Prep questions Flashcards

1
Q

Are the terms “serious” and “severe” are synonymous according to ICH.

A

No

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2
Q

Which of the following options describes the term “severe” in regards to ICH?

A

The intensity of a specific event

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3
Q

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?

A

Serious adverse drug event/ reaction

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4
Q

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?

A

False - unrelated and asymptomatic.

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5
Q

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?

A

Adverse Drug Reaction

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6
Q

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?

A
  1. A de-identified autopsy report, if available

2. Cause of death, and a comment on its possible relationship to the suspected drug reaction.

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7
Q

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?

A
  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..
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8
Q

What is the timeframe for “expedited” reporting of serious, fatal or life-threatening, unexpected adverse drug reactions to regulatory authorities?

A

As soon as possible, but no later than seven calendar days after first knowledge of the event.

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9
Q

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?

A

Adverse Drug reaction

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10
Q

What is the purpose of the IRB/IEC?

A

Safeguard the rights, safety, and well-being of all trial subjects

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11
Q

Who is responsible for designing the clinical trial protocol?

A

Sponsor

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12
Q

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

A

Informed Consent Process

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13
Q

Who is ultimately responsible for Source Data Verification or SDV?

A

Monitor

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14
Q

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?

A
  1. At least five members
  2. At least one member whose primary interest is non-scientific
  3. At least one member who is independent from the Institution/trial site
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15
Q

According to ICH E6, who must sign the Informed Consent Form or ICF?

A
  1. The person who conducted the informed consent discussion

2. The subject or the subject’s legally acceptable representative

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16
Q

As per ICH E6 GCP, which groups of potential subjects could be defined as “vulnerable subjects”?

A

Individuals whose willingness to volunteer in a trial may be unduly influenced by the expectation, whether justified or not, or worried about hierarchy of sr. members if they did not partcipate

  1. Members of the armed forces
  2. Med/Dental/Pharmacy/Nursing Students, lab personnel, employee of sponsor
  3. Persons in nursing homes
  4. Patients of incurable disease
  5. Minors
  6. Homeless
  7. Those incapable of giving consent
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17
Q

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?

A

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

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18
Q

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?

A

Adverse event, since the headaches have become more frequent

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19
Q

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.

A

Root Cause Analysis

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20
Q

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?

A
  1. Promptly notify the regulatory authority(ies)

2. Terminate the investigator’s/institution’s participation in the trial

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21
Q

Which phase of clinical research has a primary objective to demonstrate or confirm therapeutic benefit?

A

Phase 3

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22
Q

Which phase of clinical research is often called “Therapeutic Use”. It begins after drug approval.

A

Phase 4

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23
Q

The type of study that investigates human pharmacology and is the initial administration of the investigational new drug in humans

A

Phase 1

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24
Q

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.

A

Phase 2

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25
Q

Characterisation of a drug’s absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as what?

A

Pharmacokinetics

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26
Q

Which of the following is not a special population mentioned in ICH E8?

A

Prisoners

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27
Q

According to ICH E8, which of the following are response variables that are chosen to assess the drug’s effects?

A

Study endpoints

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28
Q

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.

A

True

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29
Q

Per ICH E8, methods used to evaluate patient usage of the test drug should be what?

A

Specified in the protocol and actual usage documented

30
Q

The study subject asks you why the study is called a double blind study. You explain double blind as what?

A

When the subject and the Investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects are unaware of the treatment assignments

31
Q

What does “DSMB” stand for?

A

Data Safety and Monitoring Board

32
Q

True or False? The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC)?

A

True

33
Q

What is the purpose of the “Data and Safety Monitoring Board (DSMB)”?

A

To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints

34
Q

Which of the following choices “Introduces a deliberate element of chance into the assignment of treatments to subjects in a clinical trial”?

A

Randomization

35
Q

“A design in which subjects are randomized to one of two or more arms, each arm being allocated a different treatment” is a description of what kind of trial design?

A

Parallel group design

36
Q

Which trial design is used for the specific purpose of examining the interaction of A and B?

A

Factorial Design - In a factorial trial, two (or more) intervention comparisons are carried out simultaneously. Thus, for example, participants may be randomized to receive aspirin or placebo, and also randomized to receive a behavioural intervention or standard care.

37
Q

Data and Safety Monitoring Boards or DSMBs, have the power to recommend which of the following?

A

That the sponsor can continue, modify or terminate the trial

38
Q

What do you call the clinical trial design in which each subject is randomized to a sequence of two or more treatments and hence acts as his or her own control for treatment comparisons.

A

Crossover design

39
Q

Which variable in a study should be used to determine the sample size?

A

Primary Variable - A term used in clinical trials for the outcome variable specified in the study protocol that is of greatest importance to the trial’s primary objective, and usually the one used in the sample size calculation.

40
Q

When writing an early phase clinical study plan, which of the following do you want to pay attention to, if you wish to maximize the chance of observing specific clinical effects of interest?

A

The target population

41
Q

Fill in the blank on the following statement. You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns __________, that is, the residual influence of treatments in subsequent treatment periods.

A

The carry-over effect

42
Q

Which ICH Guidance pertains to the Pediatric Population?

A

ICH E11

43
Q

True or False? Due to low blood volumes researchers should not do pharmacokinetic studies in the pediatric population.

A

False

44
Q

What is it called when a child is given information about a trial and asked if he or she wishes to participate?

A

Assent

45
Q

True or False? Medicinal products may affect physical and cognitive growth and development, and the adverse event profile may differ in pediatric patients.

A

True

46
Q

According to ICH E11, what would the suggested age catagorization for children be if you were planning a study in “children”?

A

2 to 11 years

47
Q

What are the three ways to minimize the number of samples obtained from each pediatric patient?

A
  1. Sparse sampling
  2. Use of indwelling catheters
  3. Population PK (pharmacokinetics) analysis
48
Q

True or False? Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects.

A

False

49
Q

The current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed. What is this assessment called?

A

Tanner Staging

50
Q

The pediatric population represents a vulnerable subgroup. Therefore, special measures are needed to protect the rights of pediatric study participants and to shield them from undue risk. Which of the following should be taken into consideration?

A
  1. Minimizing risk
  2. Minimizing distress
  3. recruitment
  4. Consent and assent
51
Q

What is the medicinal product dosing in the pediatric population usually based on when developing a pediatric heart disease study involving an adult approved drug?

A

Milligram (mg)/kilogram (kg) body weight

52
Q

A subject was introduced to take 1 tablet of investigational product 3 times a day, and received 80 tablets 3 weeks ago. After 21 days, the subject returns for a scheduled visit. How many tablets must the subject return to be 100% compliant?

A

17

53
Q

A CRA noticed a subject showed clinically significant liver function tests abnormalities at the subjects last study visit. The test was conducted at a local lab that was not listed in the protocol. The CRA then discovered that the local lab was not accredited. What should the CRA do next?

A

Request repeat liver function tests at an an accredited lab.

54
Q

Which of the following pieces of information of an investigational product should be included in the IB?

  1. chemical name
  2. chemical synthesis procedure
  3. instructions for the destruction of the IP
  4. adverse drug reactions
A
  1. chemical name
    and
  2. adverse drug reactions
55
Q

Briefly explain the four phases of clinical trials

A 
"Phil Explores Confirms Uses"
Phase I - Pharmacology
Phase II - Therapeutic Exploratory
Phase III - Therapeutic Confirmation
Phase IV - Therapeutic Use
56
Q

A CRA is preparing to conduct a pre-study visit. Which of the following documents will act as the best resource to provide answers to the investigator’s questions regarding the rationale for investigating the investigational product, the dose and regimen, and the risk/benefit ratio?

A

Investigator brochure

57
Q

Who is responsible for the investigational product at a site during the study?

A

The investigator

58
Q

At the close-out visit, the CRA notices that a subject has omitted information on a baseline diary. What best advice can the CRA give to the investigator?

A

Document this information as missing.

59
Q

As per ICH GCP, what information is the investigator NOT required to share with the IRB/IEC?

A

Names of all subjects whose study participation is prematurely terminated

60
Q

In Emergency situation, where the IP needs to be used for life threatening situations, what needs to be done/true for the investigator to use it?

A

Documented approval/favorable opinion of the IRB/IEC is needed for the protocol involving unconscious patients before they can be enrolled.

61
Q

What essential documents are held in a site’s trial master file?

A
  • investigational product accountability records
  • subject screening log
  • signed informed consent
62
Q

For how many years, after the completion of a trial, is the IRB/IEC required to retain the relevant records?

A

3 years

63
Q

For how many years, after the completion of a trial, is the IRB/IEC required to retain the relevant records?

A

3 years

64
Q

A subject is reviewing an informed consent for a hypertension study with the CRC. The consent includes a lengthy paragraph on discomforts and risks. The subject is concerned about the risks and remarks about them. What will be the most appropriate response from the CRC in such a case?

A

“The investigator will be available to answer your questions before the screening exam starts.”

65
Q

Which of the following statements best defines a non-clinical study?

A

A study not performed on human subjects. They provide the preliminary safety and pharmacokinetic data needed to support studies in humans

66
Q

Which of the following statements best defines a non-clinical study?

A

A study not performed on human subjects. They provide the preliminary safety and pharmacokinetic data needed to support studies in humans

67
Q

Due to the limited number of participants in a pediatric trial, what phase of the research will garner the most significant amount of safety and efficacy information?

A

Post-marketing has the most significant amount of safety and efficacy information

68
Q

Essential documents are

A

Documents which individually and collectively permit evaluation of the conduct of study and the quality of the data produced

69
Q

When should the contractual agreement between the sponsor and the investigator be signed?

A

Before the trial

70
Q

The world medical association ethical principles for medical research involving human subjects is called?

A

The declaration of Helsinki

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