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Quiz am ACRP Certification Exam Preparation Course - Practice Questions, erstellt von thaines am 27/08/2014.

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ACRP Certification Exam Preparation Course - Practice Questions

Frage 1 von 32

1

A CRA is preparing to conduct a pre-study visit. Which of the following documents should be the BEST resource for answers to the investigator's questions regarding the rationale for investigating the investigational product, the dose and regimen, and the risk/benefit ratio?

Wähle eine der folgenden:

  • Phase 1 Study Reports

  • Investigator's Brochure

  • Sample Informed Consent Form

  • Investigators' Meeting Handouts

Erklärung

Frage 2 von 32

1

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

Wähle eine der folgenden:

  • The Sponsor

  • The Monitor

  • The Investigator

  • The Pharmacist

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Frage 3 von 32

1

An Investigator is reviewing a protocol for a Phase 1 study. Which one of the following is most likely to be its objective? To determine the...

Wähle eine der folgenden:

  • ... safety and efficacy of agent "X" versus placebo in alleviating pain in patients with osteoarthritis.

  • ... therapeutic dosage of an investigational product in reducing soft tissue inflammation following third molar extractions.

  • ... dosage at which caffeine enhances acetylsalicylic acid absorption in normal, healthy volunteers.

  • ... PSA levels over time in patients with benign prostatic hypertrophy treated with a herbal extract.

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Frage 4 von 32

1

Potentially vulnerable subjects who require special consideration by an IRB/IEC include which of the following?

1. Medical, pharmacy, dental, and nursing students
2. Prisoners
3. Elderly patients living at home
4. Serving military personnel

Wähle eine der folgenden:

  • 2, 3 and 4 only

  • 1, 2 and 3 only

  • 1, 2 and 4 only

  • 1, 3 and 4 only

Erklärung

Frage 5 von 32

1

All of the following are likely stratification factors in a randomization schedule EXCEPT:

Wähle eine der folgenden:

  • Glucose Level

  • Caloric Intake

  • Disease Severity

  • Prior Study Participation

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Frage 6 von 32

1

A protocol for a new drug for the treatment of cystic fibrosis (CF) excludes patients who have received either antibiotics or corticosteroids within 2 weeks of screening, as well as patients who have started a new chronic medication for CF within 2 weeks of screening. Using these criteria, which of the following patients would be INELIGIBLE to participate in this study?

Wähle eine der folgenden:

  • A patient who was diagnosed 2 weeks ago with allergic rhinitis for which a nasal antihistamine was prescribed to be taken on a p.r.n. basis.

  • A patient who was admitted to the hospital one month ago and was put on IV antibiotics for a pulmonary infection and discharged after 3 days with a 1-week course of oral antibiotics.

  • A patient who is on longstanding treatment with prednisone to maintain pulmonary functions.

  • A patient who was seen in the emergency department 10 days ago for symptoms presenting as a migraine headache. The patient was treated with an injection of pethidine and discharged.

Erklärung

Frage 7 von 32

1

Which of the following must be described in a protocol?

Wähle eine der folgenden:

  • Information on the bio-availability of the investigational product.

  • Names and addresses of the responsible independent ethic committee(s).

  • The statistical methods to be employed.

  • The quality assurance auditing procedures.

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Frage 8 von 32

1

When reviewing a protocol, the schedule of study events would most likely be presented in?

1. The Protocol
2. The Investigator's Brochure
3. An Appendix to the Protocol
4. The Informed Consent Form

Wähle eine der folgenden:

  • 1 and 2 only

  • 1 and 3 only

  • 2 and 4 only

  • 3 and 4 only

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Frage 9 von 32

1

A crossover design is BEST described as a study...

Wähle eine der folgenden:

  • ... with a placebo run-in.

  • ... where only responders receive long term therapy.

  • ... where subjects receive all study treatments at different times.

  • ... where each dose of investigational product has a matching placebo.

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Frage 10 von 32

1

According to ICH GCP, the best description of an AE or ADR that is serious is one which is...

Wähle eine der folgenden:

  • Fatal or life-threatening, results in or prolongs inpatient hospitalization, results in persistent disability/incapacity, a congenital anomaly/birth defect.

  • All of the above plus cancer and overdose.

  • Fatal and life-threatening only.

  • An overdose of the study drug.

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Frage 11 von 32

1

A study subject develops drug-induced nephritis and is admitted to the hospital. Which answer describes this situation best?

Wähle eine der folgenden:

  • An adverse drug reaction.

  • An unexpected adverse drug reaction.

  • A serious adverse drug reaction.

  • a life-threatening adverse drug reaction.

Erklärung

Frage 12 von 32

1

During a clinical trial, which of the following are considered Serious Adverse Events?

1. Prolonged hospital stay because of an infection following surgery
2. Hospital admission following a motor vehicle accident
3. Severe rash
4. Pregnancy resulting in the normal delivery of twins

Wähle eine der folgenden:

  • 1 and 2 only

  • 1 and 3 only

  • 2 and 4 only

  • 3 and 4 only

Erklärung

Frage 13 von 32

1

Which of the following are considered tasks that the CRC would complete prior to a routine monitoring visit by a CRA?

1. Review the CRFs to ensure all data to date has been transcribed.
2. Enter all projected visit dates on the enrollment log.
3. Record investigational product dispensation completed to date.
4. Send the original CRF pages to the CRA for review.

Wähle eine der folgenden:

  • 1 and 2 only

  • 1 and 3 only

  • 2 and 3 only

  • 3 and 4 only

Erklärung

Frage 14 von 32

1

When training the investigator on a phase 3 trial, which of the following protocol sections is MOST important to emphasize?

Wähle eine der folgenden:

  • The statistical plan.

  • The pre-clinical data.

  • The publication policy.

  • The efficacy variables.

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Frage 15 von 32

1

At the close-out visit, the CRA notices that a subject has omitted information on a baseline diary. Which of the following is the BEST advice for the CRA to give the investigator?

Wähle eine der folgenden:

  • Ask the subject to complete the diary now.

  • Fill in the information based on subsequent data.

  • Discard the incomplete diary.

  • Document this information as missing.

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Frage 16 von 32

1

What action should be taken by the investigator or subinvestigator for any discrepancies between source documents and CRF?

Wähle eine der folgenden:

  • Highlight with a fluorescent pen.

  • Refer to the IRB/IEC.

  • Provide an explanation.

  • No action required.

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Frage 17 von 32

1

Investigators must send the IRB/IEC the following reports:

Wähle eine der folgenden:

  • Annual progress report

  • Monitoring visit report

  • Study initiation report

  • Patient enrollment tracking report

Erklärung

Frage 18 von 32

1

ICH GCP requires an investigator to provide the IRB/IEC with all of the following EXCEPT:

Wähle eine der folgenden:

  • Details of expenses that will be paid to subjects.

  • Significant protocol changes.

  • Names of all subjects whose participation in the study is terminated prematurely.

  • A written explanation if a study is terminated or suspended by the sponsor.

Erklärung

Frage 19 von 32

1

A document on which the subject records their consumption of study medication at home is called a:

Wähle eine der folgenden:

  • Case report form

  • Subject enrollment log

  • Subject diary

  • Investigational product accountability log

Erklärung

Frage 20 von 32

1

A CRA is responsible for which of the following during a monitoring visit?

1. Verifying subject protection
2. Confirming data recorded are verifiable from source documents
3. Reviewing medical charts for potential subjects
4. Ensuring protocol compliance

Wähle eine der folgenden:

  • 1, 2 and 3 only

  • 1, 2 and 4 only

  • 1, 3 and 4 only

  • 2, 3 and 4 only

Erklärung

Frage 21 von 32

1

An investigator is about to start a trial with seriously ill patients. He encounters a subject in a life-threatening situation for which no standard acceptable treatment is available. The investigator believes that the investigational drug may benefit this patient, who is unconscious and time is not sufficient to obtain informed consent from a legally acceptable representative. The investigator determines that the investigational drug is the only means available to increase the possibility of preserving the patient's life and decides to administer the investigational product. According to ICH GCP, which of the following is true in relation to the IRB/IEC and their approval (favorable opinion) about this emergency use:

Wähle eine der folgenden:

  • Under no circumstances can unconscious patients be enrolled without either their consent or that of their legally acceptable representative.

  • A physician who is independent of the trial must confirm the need to treat the unconscious patient with the investigational product.

  • The investigator is responsible for medical care of trial subjects so can enroll unconscious patients without prior IRB/IEC approval.

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

Erklärung

Frage 22 von 32

1

The PRIMARY responsibility of an IRB/IEC is to:

Wähle eine der folgenden:

  • Evaluate the liability of the investigator.

  • Ensure all participating subjects are protected.

  • Ensure all participating subjects sign an informed consent form.

  • Verify the risk/benefit ratio of the investigational product.

Erklärung

Frage 23 von 32

1

Which of the following are Essential Documents held in a site's Trial Master File?

1. List of staff to whom the Investigator has delegated significant trial related duties.
2. Investigational product accountability records.
3. Subject screening logs.
4. Signed informed consent forms.

Wähle eine der folgenden:

  • 1, 2 and 3 only

  • 1, 2 and 4 only

  • 1, 3 and 4 only

  • 2, 3 and 4 only

Erklärung

Frage 24 von 32

1

An IRB/IEC is required to retain records for at least how many years after completion of a trial?

Wähle eine der folgenden:

  • 2 years

  • 3 years

  • 5 years

  • 10 years

Erklärung

Frage 25 von 32

1

When the investigator or his/her team make changes or corrections to a CRF, which action should they take?

Wähle eine der folgenden:

  • Over-write the original entry.

  • Write them in red ink in the margin.

  • Ensure that they are all explained.

  • Initial and date each correction.

Erklärung

Frage 26 von 32

1

An experienced PI was not available to attend the investigator's meeting for a multi-center study. The PI now discovers a conflict prohibiting attendance at the site initiation meeting, but all other study team members are confirmed to attend in 2 days time. Which of the following is the best course of action?

Wähle eine der folgenden:

  • Reschedule the initiation meeting.

  • Confirm that the investigator's experience with the investigational product is current.

  • Hold the initiation meeting as scheduled and review content with the investigator at the earliest opportunity.

  • Request that study staff review the initiation meeting content with the investigator and produce meeting minutes.

Erklärung

Frage 27 von 32

1

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 remarks about this and is concerned. Which of the following is the MOST appropriate response?

Wähle eine der folgenden:

  • The regulatory authorities require that all known and possible side effects be listed.

  • Hypertension medications can cause numerous side effects, but most are not serious.

  • The investigator will be available to answer your questions before the screening examination starts.

  • This is a reference list for collecting relevant data on adverse events occurring during the study.

Erklärung

Frage 28 von 32

1

Which is the most important document when preparing for an audit?

Wähle eine der folgenden:

  • Investigator's Brochure

  • Monitoring Guidelines

  • Trial Master File

  • Trial Protocol

Erklärung

Frage 29 von 32

1

What is a non-clinical study?

Wähle eine der folgenden:

  • A study performed outside a clinic (e.g., at a general practitioner or in a Phase 1 Center).

  • A study not performed on human subjects.

  • A study performed in healthy volunteers.

  • A study using an external medical device in patients with heart disease.

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Frage 30 von 32

1

Quality control of clinical trials by sponsors includes:

1. The use of SOPs
2. Pre-trial visits to assess suitability of sites
3. Monitoring visits
4. Inspections

Wähle eine der folgenden:

  • 1, 2 and 3

  • 1, 2 and 4

  • 1, 3 and 4

  • 2, 3 and 4

Erklärung

Frage 31 von 32

1

Who has ultimate responsibility for the quality and integrity of the data in a contracted trial?

Wähle eine der folgenden:

  • The Contract Research Organization

  • The Sponsor

  • The Regulatory/Competent Authority

  • An Independent Data Monitoring Committee

Erklärung

Frage 32 von 32

1

In addition to being familiar with the different types of questions on your upcoming certification exam, all of the following steps should also be taken in preparing for your certification exam EXCEPT:

Wähle eine der folgenden:

  • Assess your readiness for the exam.

  • Block out time for studying .

  • Check the 5 relevant guidelines and detailed contact outline.

  • Delay making any plans.

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