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ACRP - CCRC Exam > 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 and terminal medical report

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.
-an addiontal 8 days later for follow up report

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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 a selected population of 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

Name the special populations mentioned in ICH E8?

A

Children, pregnant women, lactating women, geriatric population

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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

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

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30
Q

What does “DSMB” stand for?

A

Data Safety and Monitoring Board

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31
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

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32
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

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33
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

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34
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

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35
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

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36
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

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37
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.

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38
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

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39
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

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40
Q

Which ICH Guidance pertains to the Pediatric Population?

A

ICH E11

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41
Q

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

A

False

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42
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

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43
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

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44
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

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45
Q

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

A

False

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46
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
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47
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

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48
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

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49
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.

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50
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
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51
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
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52
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

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53
Q

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

A

The investigator

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54
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.

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55
Q

As per ICH GCP, is the investigator required to share the names of all subjects whose study participation is prematurely terminated to the IRB/IEC?

A

No

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56
Q

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

A
  • investigational product accountability records
  • subject screening log
  • signed informed consent
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57
Q

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

A

3 years

58
Q

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

A

3 years

59
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.”

60
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

61
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

62
Q

Essential documents are

A

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

63
Q

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

A

Before the trial beings

64
Q

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

A

The declaration of Helsinki

65
Q

Which entity is primarily charged with considering subject rights and well-being during clinical trials?

A

IRB / IEC

66
Q

Thirty-two subjects are enrolled in a neurology study in which 50 subjects eventually will be enrolled. The CRC notes that 25 of these 32 subjects have developed a cough. The CRC should now do which of the following actions.

  • Report the observation to the sponsor.
  • Ask the IRB/IEC permission to continue the study.
  • Inform the CRA at the next monitoring visit.
  • Modify the screening questionnaire to ask about cough.
A

Report the observation to the sponsor

67
Q

A CRA noticed that a subject showed clinically significant liver function test abnormalities on the subject’s last study visit. The test was conducted at a local laboratory not listed in the protocol. The CRA then discovered that the local laboratory was not accredited. What should the CRA do first?

  • Recommend suspending study activities at the site.
  • Recommend admitting the subject to the hospital.
  • Request a repeat liver function test at an accredited laboratory.
  • Request subjects’ randomization codes for the coordinator at the site.
A

Request a repeat liver function test at an accredited laboratory.

68
Q

An Investigator’s Brochure should contain which of the following about an investigational product?

  1. Chemical name
  2. Chemical synthesis procedures
  3. Instructions for destruction of the investigational product
  4. Adverse drug reactions
    - 1 and 2 only
    - 2 and 3 only
    - 3 and 4 only
    - 1 and 4 only
A

1 and 4 only

69
Q

What does DSMB stand for?

A

Data and Safety Monitoring Board

70
Q

What is the primary purpose of a Phase I study?

A

To determine the metabolic and pharmacologic action of the drug in humans
-initial safety and tolerability

71
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 clinical efficacy endpoints.

72
Q

What does hte IRB/IEC evaluate?

Select all that apply

  1. The subject-selection procedure
  2. The scientific tenability of hte trial
  3. The rights, safety, and well-being of the subjects participating in the trial
  4. The contract between teh sponsor and investigator
A

1, 2, 3

73
Q

What is the purpose of the initiation visit?

Select all that apply

  1. To review the protocol
  2. To review standard procedures
  3. To review the blank Case Report Forms (CRFs)
  4. To carry out source document verification
A

1, 2, 3

74
Q

Who is ultimately responsible for Source Data Verification (SDV)?

A

the monitor

75
Q

Most typical study, investigates human pharmacology. It is the initial administration or an investigatinal new drug into humans. It is most commonly done in healthy subjects.

A

Phase 1

76
Q

Providing a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials is the…..

A

Mission statement of the ICH

77
Q

An investigator can be defined as….

Select all that apply

  1. A person responsible for writing the trial protocol.
  2. A person responsible for the conduct of the clinical trial at the trial site
  3. The responsible leader of the clinical research team at the site and may be called the principal investigator.
  4. A person responsible for the conduct of the clinical trial with the sponsor.
A

2 and 3

78
Q

A sub-investigator can be defined as….

A

Any individual member of ht eclinical trial team designated and supervised by the investigator at a trial site to perform clinical trial-related procedures and/or to make important trial-related decisions.

79
Q

According to the principles of ICH GCP…

Select all that apply

  1. Chilical trials should be conducted in accordanece with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
  2. The available nonclinical and clinical informaiton on an investigational product should be adequate to support the purposed clinical trial.
  3. Before a trial is initiated, forseeable risks and inconveniences should be weighted against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  4. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
A

1, 2, 3, and 4

80
Q

Which of the following should the investigator do if a Serious Adverse Event (SAE) occurs?

Select all that apply

  1. Inform the IRB/IEC, if required by local regulations.
  2. Report it to the monitor during the next study visit.
  3. Inform the sponsor immediately.
  4. Discontinue the subject from the study.
A

1 and 3

81
Q

After an SAE has occurred, how should a subject identification occur on the immediate and follow-up records?

A. By the subject identification number

B. By their name

C. By a unique code for serious Adverse Event (AE) reporting

D. By their address.

A

A. By their subject identification number.

82
Q

In the event of a subject’s death, what additional information shoudl be supplied to the sponsor?

Select all that apply

  1. The address of the next of kin so that the sponsor can write a letter of condolence.

B. The name and address of the subjet’s general practitioner

C. Terminal medical reports, if available

D. An autopsy report, if available

A

C and D

83
Q

What documentation should be supplied to the sponsor before the study?

Select all that apply

  1. The completed subject informed consent forms.
  2. The CVs of all investigators and other study personel who are significantly involved in trial related duties.
  3. The signed contract between sponsor and investigator.
  4. The completed Case Report Forms (CRF)
A

2 and 3

84
Q

What details need to be documented in the subject notes when the AE occurs?

Select all that apply.

!. What the subject thinks caused the event.

  1. When the event occurred.
  2. The severity of the event.
  3. No documentation is necessary.
A

2 and 3

85
Q

Who is responsible for the appropriate monitoring of clinical trials?

A

the sponsor

86
Q

During the trial, who is responsible for communicating with the IRB/IEC?

A

the investigator

87
Q

Which of the following individuals could be members of an IRB/IEC?

Select all that apply

  1. Trial Subjects
  2. Medical professionals
  3. Lay people
  4. The sponsor
A

2 and 3

88
Q

In which format shoudl approval be received from the IRB/IEC?

A

Written

89
Q

Which of the following criteria is described in ICH’GCP as necessary for classifying an Adverse Event (AE) as an Adverse Drug Reaction (ADR)?

A. That a causal relationship is a strong possibility

B. That a causal relationship is a very strong possibility

C. That a causal relationship is a definite possibility

D. That a causal relationship is at least a reasonable possibility.

A

D. That a causal relationship is at least a reasonable possibility.

90
Q

What information needs to be included in the subject’s medical records?

Select all that apply.

Medical history

Randomization number

Occurrence of any AEs

Name of the monitor

A

Medical history

Randomization number

Occurrence of any AEs

91
Q

Which groups of potential subjects are mentioned in ICH-GCP as being ‘vulnerable subjects’?

Select all that apply.

  1. Employees of the pharmaceutical industry
  2. Junior members of the medical profession
  3. People with heart conditions
  4. Members of the armed forces
A

1, 2, and 4

92
Q

Who conducts clinical research Quality Control (QC) activities?

A

Sponsor

93
Q

According to the Declaration of Helsinki, physicians may use an unproven intervention.

A

True

if in physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. T

94
Q

What is the minimum amount of time after formal discontinuation of the clinical development of an investigational product that essential documents should be retained according to ICH-GCP?

A

2 years after the last marketing application approval in an ICH-GCP region

95
Q

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and it cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the resarch.

TRUE or FALSE ?

A

TRUE

96
Q

A candidate presents him/herself for a monitor position. What qualifications should the potential monitor be able to provide proof of to be considered for the position?

Select all that apply.

  1. Have the clinical knowledge needed to monitor a trial.
  2. Have the scientific knowledge needed to monitor a trial.
  3. Be familiar with GCP
  4. A bachelor degree
A

1, 2, and 3

Reference: ICH E6 section 5.18.2

97
Q

A monitor is tasked to select investigators for a new upcomig oncology trial. What evidence of qualifications should the potential investigator be able to provide to be considered for the conduct of the trial?

Select all that apply.

  1. A university degree
  2. Evidence of awareness of and compliance with GCP and the regulatory requirements.
  3. A log of training records of all trial specific training the investigator ever took.
  4. An up to date CV, showing evidence of adequate education, training, and experience.
A
  1. Evidence of awareness of and compliance with GCP and the regulatory requirements.
  2. An up to date CV, showing evidence of adequate education, training, and experience.
98
Q

A subject visits the investigator at the scheduled visit window in her office as an outpatient and reports he suffers from a fever after being treated by the Investigational Product (IP) for a week. Is this occurrence an AE or an or ADR?

A

This is an AE becuse it can be classified as an untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

99
Q

When is verbal consent prior to participation in a research study permitted?

A

When the subject is illiterate.
*needs impartial witness present

100
Q

Which signatures are required by ICH Guidelines to be on the Informed Consent Form?

Select all that apply.

  1. the investigator
  2. the subject
  3. the person who conducted the infomred consent discussion
  4. the investigator and the subject
A

2 and 3

101
Q

For the investigational drug studies, the sponsor must provide the investigators with the:

Select all that apply.

  1. Full Investigational New Drug Application (IND)
  2. Latest package insert
  3. Safety surveillance updates
  4. Investigator brochure
A
  1. investigator brochure
102
Q

Whose responsibility is it to safeguard the rights and safety of subjects in clinical trials?

Select all that apply.

  1. The investigator
  2. The sponsor
  3. The IRB.IEC
  4. The subjects’ general practitioner
A

1, 2, and 3

the investigator

the sponsor

the IRB.IEC

103
Q

Who does hte investigator need to inform if he/she deviates from the protocol?

Select all that apply.

  1. The regulatory authorities
  2. The sponsor
  3. The IRB.IEC
  4. The office staff
A

1, 2, and 3

The regulatory authorities

The sponsor

The IRB/IEC

104
Q

Who should have access to ALL trial files?

Select all that apply

  1. The subject
  2. The investigator
  3. The pharmacist
  4. The monitor
A
  1. The investigator
  2. The monitor
105
Q

An AE that is severe in intensity may not meet the definition of ____________________

A

May not meet the definition of serious

106
Q

A subject in its third trial week in an oncology trial at a hospital site asks the investigator during a follow-up visit for some clarifications on the Investigational Product (IP) dosage used. The investigator refers the subject to the pharmacist for more informaiton as (s)he claims not to know the details of how to use th IP. Is this answer in compliance with the GCP E6 guideline?

A

No. The investigator should be thoroughly familiar with the appropriate use of the IP as described in the protocol and the current Investigator’s Brochure and should explain the correct use to and do periodic checks for understanding compliance with the subject.

107
Q

The subject arrives for the informed consent interview, but the investigator has no more informed consent forms. What should the investigator do?

Select all that apply

  1. Write the details on a blank piece of paper.
  2. Photocopy another subject’s form and use correction fluid to remove the details.
  3. Have already made sure that there were enough forms before the interview.
  4. Ask the subject to come back.
A
  1. Have already made sure that there were enough forms before the interview.
  2. Ask the subject to come back.
108
Q

A site is being renovated and no longer has adequate storage space to hold all of the past studies it has conducted. Some studies are older than 20 years. Some Investigational Products (IPs) are now marketed. How can the site determine which files it still needs to store?

A

Contact the sponsor for each trial to ask for a letter outlining instructions for disposition of records.

109
Q

An investigator wants to enroll a diabetes patient into a clinical trial. The inclusion criteria require results of blood tests to confirm general status of diabetes. What lab results can be used to check compliance with the inclusion criteria?

Select all that apply

  1. The lab results as part of the normal medical practice after the ICF was signed.
  2. The lab results after the ICF was signed.
  3. The lab results before the ICF was signed.
  4. The lab results as part of the normal medical practice before the ICF was signed.
A

1, 2, and 4

110
Q

A monitor is making corrections on the CRF during a monitoring visit and asks the site staff (as identified on the signature and delegation log) to sign and date these corrections. This is an accepted way of working because:

A

It does not matter who makes the corrections on the CRF (sponsor representatives or site staff identified on the signature and delegation log) as long as they are made when necessary, endorsed by the investigator, and documented.

111
Q

In general, unused investigational drugs:

A

Must be returned to the sponsor.

112
Q

Who may have direct access to the subjects’ medical records?

Select all that apply

  1. All those named in the informed consent form signed by the subject.
  2. All qualified hospital staff.
  3. The investigator by default
  4. The monitor by default.
A
  1. All those named on the informed consent form signed by the subjects
  2. The investigator by default.

has to be stated in ICF that monitor/CRO has access to medical records

113
Q

At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states, “The doctor told me I was very lucky. I might have died.” Having received this information, the MOST appropriate sequence of action is to inform the

A

PI, sponsor, and IRB.IEC

IN THAT ORDER

114
Q

A subject is upset and wants to know whom she should contact regarding her rights as a research subject. The CRC should tell her to contact the

A. PI

B. regulatory authority

C. risk management department

D. individual listed in the ICF

A

D. individual listed on the ICF

While it might be the PI, this reference includes the elements of the informed consent that should be included. Section (q) states that the person(s) to contact for further information regarding the trial and the rights of trial subjects, and specifically who to contact in the event of trial-related injury, should be included. A, B, and C are not the best answer. The purpose of the question is to ensure the candidate knows that this is referred to in the ICF.

115
Q

The trough blood level for a once-daily drug should be drawn how long after the last dose?

A. immediately

B. 4 hours

C. 12 hours

D. 24 hours

A

D. 24 hours

Definition of trough (lowest serum concentration level of a drug). This would be defined in the IB.

The trough level should be measured just before the administration of the next dose.

116
Q

A CRC has received three subject complaints of localized infection at the venipuncture site. The CRC queries the phlebotomist and discovers that when the first stick is unsuccessful, any additional sticks are done with the same needle. This is in violation of the site’s SOPs. Which of the following actions should the CRC take?

  1. Suggest review of proper specimen collection for the phlebotomist.
  2. Document and report the findings.
  3. Inform the IRB/IEC of the situation and the corrective action.
  4. Report the incidents to the IDMC/DSMB.
A

1 and 2 only

[1] CORRECT E6 1.55 discusses that SOPs are written detailed instructions to achieve uniformity of the performance of a specific function. We know from the stem that the phlebotomist isn’t following site SOPs, so it would be correct to review the procedures. [2] CORRECT E6 4.2.4 discusses that the investigator should ensure that all persons assisting with the trial are adequately informed on the duties and functions. [3] WRONG There is no specific requirement to report it to the IRB/IEC (though each IRB might have instructions like that, it’s not across the board). [4] WRONG There is no guidance to report it to the DSMB.

117
Q

All of the following are regulatory documents EXCEPT

A. informed consent

B. protocol signature page

C. laboratory certification

D. confidentiality agreement

A

D. confidentiality agreement

Regulatory documents demonstrate the compliance of the Investigator, Sponsor and IRB/IEC with the standards of Good Clinical Practice and with all applicable regulatory requirements [A] WRONG: the informed consent is a regulatory document because it is a process by which a subject confirms willingness to participate in a trial . This document has to be approved by the IRB/IEC. [B] WRONG: the protocol signature page is signed by the PI and sponsor to document agreement to the protocol and amendments [C] WRONG: a laboratory certification documents competence of the facility to perform required tests and support reliability of results. [D] CORRECT: a confidentiality agreement is a nondisclosure contract entered into by the sponsor and the investigator and is not governed by regulatory authorities

118
Q

A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation, drug accountability log, subject identification code list, documentation of IP destruction, and final report to the IRB/IEC. Which of the following actions should the CRC perform?

  1. Send the treatment decoding documentation to the sponsor.
  2. Remove the subject identification code list from the material to be filed at institution.
  3. Send copies of the IP destruction forms to the sponsor.
  4. Remove the drug accountability log from the material to be sent to the sponsor.
A

1, 2, and 3

  1. Correct-the Sponsor retains the Decoding Documentation 2. Correct-the Subject ID Code list is to be kept at the site in a confidential manner 3. Correct-documentation of the destruction is kept at the site [if the IP was destroyed at the site] and with the sponsor. 4. Wrong-documentation of IP accountability is kept at both the site and with the sponsor [A] CORRECT: 1,2,and 3 are all correct
119
Q

Which of the following is a liver function test?

A. TSH

B. LDH

C. BUN

D. Hct

A

B. LDH

A] WRONG - Thyroid Stimulating Hormone – test used to assess the function of the thyroid gland [B] CORRECT - Lactate Dehydrogenase – test used to check for damage to the tissue of the heart, liver, kidney, muscles, brain, blood cells, and lungs. [C] WRONG - Blood Urea Nitrogen – kidney function test [D] WRONG - Hematocrit - blood test measuring the percentage of the volume of whole blood that is made up of red blood cells. To be certified, candidates are expected to have general knowledge of laboratory terminology, tests and procedures.

120
Q

According to ICH Guidelines, the source document should contain which of the following information regarding informed consent?

A. time the consent form was signed by the subject

B. date the PI and subject signed the consent form

C. date and tiem the consent form was signed by the witness

D. evidence that the consent form was signed prior to trial-related procedures

A

D. evidence that the consent form was signed prior to trial-related procedures

A] WRONG This is not covered in ICH. Time signed is not required (although it may be per the IRB, it is not required per ICH). [B] WRONG The PI is not required to sign the form, it’s the person conducting the consent. [C] WRONG A witness may or may not be required. [D] CORRECT E6 4.8.8 says that the ICF must be completed prior to subject’s participation.

121
Q

A clinical trial is being conducted for hormone replacement. The trial includes a diary. Which of the following would be considered an objective parameter?

A. mood swings

B. breast tenderness

C. severity of hot flashes

D. episodes of vaginal bleeding

A

D. epsidoes of vaginal bleeding

An objective symptom can be measured or observed and is not dependent on, or influenced by, the subject’s feelings or opinions [A] WRONG-mood swings are measured by the subject’s opinion [B] WRONG-breast tenderness is measured by the subject’s opinion [C] WRONG-severity of hot flashes is measured by the subject’s opinion [D] CORRECT-vaginal bleeding is observed

122
Q

A subject presents at a site with her husband, after pre-qualifying on a phone screen. She states that she is legally blind and cannot read the ICF. A Braille ICF is not available. This subject is able to sign her name if her hand is guided to the signature line. Which of the following is the BEST course of action to obtain legal consent for this subject?

A. The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding.

B. Her husband can sign the ICF for her after it has been read to the subject and she verbally states her understanding.

C. The subject does not qualify as she is unable to read the ICF herself and a Braille consent form is not available.

D. An investigator must co-sign the ICF after it has been read to the subject and she verbally states her understanding and has signed the ICF.

A

A. The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding.

[A] CORRECT E6 4.8.9 discusses, specifically, the need for an impartial witness when a subject is unable to read (there wouldn’t necessarily be a LAR in this case). The impartial witness should be present for the entire discussion. They are not just witnessing a signature. Reference E6 1.26 further clarifies who an impartial witness can be and it would not include the spouse, so the husband wouldn’t be appropriate to sign. [B] WRONG There is no indication that the husband is the LAR [C] WRONG Unless vision is an inclusion criteria, there is nothing to indicate that she does not qualify due to being legally blind [D] WRONG The regulations do not support this. Only the subject (or LAR) and person conducting the consent must sign. An impartial witness is used in some cases as in the reference.

123
Q

What is Creat?

A

Creatinine - waste product produced by muscles breakdown, removed from the body by kidneys which filters almost all of it from blood and releases it as urine. It assesses kidney function, usually ordered with BUN - Blood urea nitrogen

124
Q

A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans would MOST likely involve

  1. healthy volunteers.
  2. pharmacokinetic analysis.
  3. placebo control.
  4. dose escalation.
A

D. 2 and 4 only

1] WRONG Phase I trials may be done in healthy volunteers AND certain types of patients (they are NOT always limited to healthy volunteers). [2] CORRECT: Phase I trials are primarily involved with PK sampling [3] WRONG: Phase I may or may not use a placebo control; however it would not be ethical in a recurrent brain tumor study. [4] CORRECT: Dose escalations are primarily done in Phase I trials. Option D is the only choice with both of the correct statements.

125
Q

A competent adult subject signs a consent form with an “X” and indicates approval. Which of the following is the BEST action for the CRC to take?

A. Have the consent form notarized.

B. Exclude the subject from the trial.

C. Document why the subject signed with an “X”

D. Have the legal guardian sign the informed consent form.

A

C. Document why the subject signed with an X”

[A] WRONG There is no mention in the guidelines for notarization [B] WRONG There is no indication that this subject should be excluded from the trial (protocol specific) [C] CORRECT The reference E6 4.8.8 talks about the subject signing and personally dating the ICF by the subject (or LAR). In this case, the subject is competent but can’t write their name. The best course of action is to have the subject sign as best as they can and then document that the “X” was made by the subject. [D] WRONG There is generally no LAR for a competent individual.

126
Q

In addition to obtaining a signed informed consent form, which of the following should be documented in the research record?

  1. the time and date that the procedures will be performed
  2. that the subject’s questions were answered
  3. the names of people present during the consent process
  4. that no trial procedures were performed prior to consenting
A

C. 2 and 4 only

1] and [3] WRONG these are not listed in the references. [2] and [4] CORRECT these are listed in the E6 reference. E6 4.8.7 speaks to answering a subject’s questions. E6 4.8.8 talks about the ICF needing to be signed and dated by the subject (etc.) prior to a subject’s participation.

127
Q

A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in their diaries for the first 7 days of the trial. Upon review with the subjects, there were no related complaints. Which of the following should be the CRC’s FIRST action?

A. Notify the sponsor.

B. Contact the manufacturer

C. Inform the remaining 20 subjects.

D. Replace existing thermometers with an alternate model.

A

A. Notify the sponsor.

[A] CORRECT- the sponsor is responsible for maintaining quality assurance and control [B] WRONG- the sponsor would contact the manufacturer [C] WRONG- the CRC would inform the remaining subjects if instructed to do so by the sponsor [D] WRONG-the sponsor is responsible for supplying the equipment for this trial

128
Q

A potential subject for a trial has been mailed an ICF prior to his screening visit. When the subject arrives at the research department for his screening visit, he states he read the ICF and is ready to do the trial. He does not have the copy of the ICF that was mailed to his home with him. According to the ICH Guidelines, which of the following are the BEST actions for the CRC to take initially?

  1. Have the subject sign the ICF.
  2. Document that the subject reviewed the ICF at home.
  3. Tell the subject to keep the ICF mailed to the home as his copy.
  4. Confirm the subject’s understanding of the ICF.
A

1 and 4 only

1] CORRECT Reference E6 4.8.8 states that the ICF will be signed and personally dated by the subject. The way to ensure this is to have the subject sign and date in the presence of the person conducting the ICF process. [2] WRONG While it’s OK to document that the subject reviewed the ICF at home, it’s not sufficient per the ICH guidelines. [3] WRONG telling the subject to keep the ICF mailed to the home as his copy does NOT meet the ICH guidelines per E6 4.8.11 (the subject should receive a copy of the signed and dated ICF). [4] CORRECT E6 4.8.7 supports option 4 that the subject understands the ICF (having all questions answered).

129
Q

A sponsor/investigator (investigator-initiated research) expands a trial from a single site to four trial sites in different areas of the country. The sponsor/investigator should do which of the following?

  1. Monitor compliance with GCP.
  2. Report AEs to the sites.
  3. Keep investigators informed of new findings.
  4. Update investigators regarding subject recruitment.
A

1 and 3 only

1] CORRECT The references speak to a sponsor (in this case the investigator) ensuring that the trial is conducted in compliance with the approved protocol (E6 5.18 (c) [2] WRONG there’s no regulation to report regular (non-serious) adverse events to the sites participating in the trial. [3] CORRECT E6 5.16.2 talks about promptly notifying all concerned investigators of finding that could affect safety or impact the trial. [4] WRONG an investigator might keep everyone up to date on recruitment but it’s not in the guidelines

130
Q

At a trial site, CRCs perform quality assurance as needed throughout the progress of their trials. A CRC notes that five of the seven research nurses failed to document subject understanding of the trial. Which of the following actions should the CRC perform?

  1. Inform the sponsor of this practice.
  2. Revise the delegation of responsibility.
  3. Ensure the subjects have been well informed of the trial.
  4. Review the informed consent process with the individual research nurses.
A

3 and 4 only

1] WRONG This is an internal issue at this point and the sponsor would not need to be informed. [2] WRONG There is no indication that delegation was incorrect; this is a training issue. [3]CORRECT E6 4.8.1 discusses that staff should comply with regulatory requirements. Part of those requirements are actually in E6 4.8.7 where the person conducting the consent would ensure all questions are answered (which should be documented or it’s not done). [4] CORRECT The references discuss having adequate staff and that the staff are trained. This is a training issue.

131
Q

What does IDMC stand for?

A

Independent Data Monitoring Committee

132
Q

1 lb = ___kg

A

0.45

133
Q

BUN

A

Blood Urea Nitrogen

kidney function test

134
Q

AST

A

Aspartate Aminotransferase Test

checks for liver damage

135
Q

ALT

A

Alanine Aminotransferase

checks for liver damage

136
Q

AMS

A

assess pancreas
*amylase

137
Q

Lipase

A

pancreas

usually ordered with amylase

*LPS

138
Q

ALK Phos

A

liver, gallbladder, bones
(ALP - Alkanine Phosphatase Level Test)

139
Q

TSH

A

used to test the function of the thyroid gland
*(Thyroid Stimulating Hormone)

140
Q

LDH

A

test used to check for damage to the tissue of the heart, liver, kidney, muscles, brain, blood cells, and lungs
*(Lactate Dehydrogenase)

141
Q

Hematocrit

A

blood test measuring the percentage of the volume of whole blood that is made up of red blood cells
*Hct

ACRP - CCRC Exam (14 decks)

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