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ACRP Certification Exam Preparation Course - Practice Questions
Questions in this quiz (32)
1A 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?
- APhase 1 Study Reports
- BInvestigator's Brochure
- CSample Informed Consent Form
- DInvestigators' Meeting Handouts
2Who is responsible for the investigational product at a site during the study?
- AThe Sponsor
- BThe Monitor
- CThe Investigator
- DThe Pharmacist
3An 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...
- A... safety and efficacy of agent "X" versus placebo in alleviating pain in patients with osteoarthritis.
- B... therapeutic dosage of an investigational product in reducing soft tissue inflammation following third molar extractions.
- C... dosage at which caffeine enhances acetylsalicylic acid absorption in normal, healthy volunteers.
- D... PSA levels over time in patients with benign prostatic hypertrophy treated with a herbal extract.
4Potentially 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- A2, 3 and 4 only
- B1, 2 and 3 only
- C1, 2 and 4 only
- D1, 3 and 4 only
5All of the following are likely stratification factors in a randomization schedule EXCEPT:
- AGlucose Level
- BCaloric Intake
- CDisease Severity
- DPrior Study Participation
6A 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?
- AA 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.
- BA 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.
- CA patient who is on longstanding treatment with prednisone to maintain pulmonary functions.
- DA 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.
7Which of the following must be described in a protocol?
- AInformation on the bio-availability of the investigational product.
- BNames and addresses of the responsible independent ethic committee(s).
- CThe statistical methods to be employed.
- DThe quality assurance auditing procedures.
8When 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- A1 and 2 only
- B1 and 3 only
- C2 and 4 only
- D3 and 4 only
9A crossover design is BEST described as a study...
- A... with a placebo run-in.
- B... where only responders receive long term therapy.
- C... where subjects receive all study treatments at different times.
- D... where each dose of investigational product has a matching placebo.
10According to ICH GCP, the best description of an AE or ADR that is serious is one which is...
- AFatal or life-threatening, results in or prolongs inpatient hospitalization, results in persistent disability/incapacity, a congenital anomaly/birth defect.
- BAll of the above plus cancer and overdose.
- CFatal and life-threatening only.
- DAn overdose of the study drug.
11A study subject develops drug-induced nephritis and is admitted to the hospital. Which answer describes this situation best?
- AAn adverse drug reaction.
- BAn unexpected adverse drug reaction.
- CA serious adverse drug reaction.
- Da life-threatening adverse drug reaction.
12During 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- A1 and 2 only
- B1 and 3 only
- C2 and 4 only
- D3 and 4 only
13Which 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.- A1 and 2 only
- B1 and 3 only
- C2 and 3 only
- D3 and 4 only
14When training the investigator on a phase 3 trial, which of the following protocol sections is MOST important to emphasize?
- AThe statistical plan.
- BThe pre-clinical data.
- CThe publication policy.
- DThe efficacy variables.
15At 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?
- AAsk the subject to complete the diary now.
- BFill in the information based on subsequent data.
- CDiscard the incomplete diary.
- DDocument this information as missing.
16What action should be taken by the investigator or subinvestigator for any discrepancies between source documents and CRF?
- AHighlight with a fluorescent pen.
- BRefer to the IRB/IEC.
- CProvide an explanation.
- DNo action required.
17Investigators must send the IRB/IEC the following reports:
- AAnnual progress report
- BMonitoring visit report
- CStudy initiation report
- DPatient enrollment tracking report
18ICH GCP requires an investigator to provide the IRB/IEC with all of the following EXCEPT:
- ADetails of expenses that will be paid to subjects.
- BSignificant protocol changes.
- CNames of all subjects whose participation in the study is terminated prematurely.
- DA written explanation if a study is terminated or suspended by the sponsor.
19A document on which the subject records their consumption of study medication at home is called a:
- ACase report form
- BSubject enrollment log
- CSubject diary
- DInvestigational product accountability log
20A 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- A1, 2 and 3 only
- B1, 2 and 4 only
- C1, 3 and 4 only
- D2, 3 and 4 only
21An 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:
- AUnder no circumstances can unconscious patients be enrolled without either their consent or that of their legally acceptable representative.
- BA physician who is independent of the trial must confirm the need to treat the unconscious patient with the investigational product.
- CThe investigator is responsible for medical care of trial subjects so can enroll unconscious patients without prior IRB/IEC approval.
- DDocumented approval or favorable opinion from the IRB/IEC is needed for a protocol involving unconscious patients before they can be enrolled.
22The PRIMARY responsibility of an IRB/IEC is to:
- AEvaluate the liability of the investigator.
- BEnsure all participating subjects are protected.
- CEnsure all participating subjects sign an informed consent form.
- DVerify the risk/benefit ratio of the investigational product.
23Which 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.- A1, 2 and 3 only
- B1, 2 and 4 only
- C1, 3 and 4 only
- D2, 3 and 4 only
24An IRB/IEC is required to retain records for at least how many years after completion of a trial?
- A2 years
- B3 years
- C5 years
- D10 years
25When the investigator or his/her team make changes or corrections to a CRF, which action should they take?
- AOver-write the original entry.
- BWrite them in red ink in the margin.
- CEnsure that they are all explained.
- DInitial and date each correction.
26An 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?
- AReschedule the initiation meeting.
- BConfirm that the investigator's experience with the investigational product is current.
- CHold the initiation meeting as scheduled and review content with the investigator at the earliest opportunity.
- DRequest that study staff review the initiation meeting content with the investigator and produce meeting minutes.
27A 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?
- AThe regulatory authorities require that all known and possible side effects be listed.
- BHypertension medications can cause numerous side effects, but most are not serious.
- CThe investigator will be available to answer your questions before the screening examination starts.
- DThis is a reference list for collecting relevant data on adverse events occurring during the study.
28Which is the most important document when preparing for an audit?
- AInvestigator's Brochure
- BMonitoring Guidelines
- CTrial Master File
- DTrial Protocol
29What is a non-clinical study?
- AA study performed outside a clinic (e.g., at a general practitioner or in a Phase 1 Center).
- BA study not performed on human subjects.
- CA study performed in healthy volunteers.
- DA study using an external medical device in patients with heart disease.
30Quality 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- A1, 2 and 3
- B1, 2 and 4
- C1, 3 and 4
- D2, 3 and 4
31Who has ultimate responsibility for the quality and integrity of the data in a contracted trial?
- AThe Contract Research Organization
- BThe Sponsor
- CThe Regulatory/Competent Authority
- DAn Independent Data Monitoring Committee
32In 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:
- AAssess your readiness for the exam.
- BBlock out time for studying .
- CCheck the 5 relevant guidelines and detailed contact outline.
- DDelay making any plans.
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- Quiz on ACRP Certification Exam Preparation Course - Practice Questions, created by thaines on 27/08/2014.
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- thaines
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