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The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers is: a. phase 1 b. phase 2 c. phase 3 d. phase 4 - Correct Answer ✅a Which of the following is not a type of patient-oriented research? a. IND/IDE clinical trials b. investigator initiated trial (IIT) c. Post market device registries d. outcome and health services research - Correct Answer ✅d Who is ultimately responsible for all aspects of the research conducted at a site?
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a. IRB b. sponsor c. principal investigator d. clinical research coordinator - Correct Answer ✅c What is the definition of good clinical practice (GCP)? a. training provided by sponsors to site staff b. regulations provided by the FDA c. standards developed by european union d. an international quality standard that is provided by ICH - Correct Answer ✅d What event resulted in the Nuremburg Code in 1949? a. thalidomide tragedy b. tuskegee syphilis study c. sulfanilamide Elixir tragedy
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a. BIMO b. CBER c. CDER d. CDRH - Correct Answer ✅b What is the international conference on harmonization (ICH) guidelines? a. written policies for researchers on how to maintain data on unmarketed investigational products b. a guideline provided by the office for human research protection for subjects enrolling in phase 1 studies c. a unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the european union, japan and the united states d. an international standard for manufacturing, transporting, - Correct Answer ✅c To be a qualifying clinical trial, which three requirements must be met?
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a. the trial has therapeutic intent, has an investigational new drug number, and enrolls patients with diagnosed disease b. the trial has therapeutic intent, enrolls patients with diagnosed disease and evaluates an item/service that falls within a medicare benefit category c. the trial has therapeutic intent, has an investigational new drug number, and does not evaluate an item/service that falls within a medicare benefit - Correct Answer ✅b A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate is known as an: a. assent b. informed consent c. subject agreement d. dissent - Correct Answer ✅b
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rejection of an application); is valid one year; and must be updated within ___ days of taking effect a. 30, 60 b. 60, 30 c. 90, 90 d. 120, 60 - Correct Answer ✅a Which phase of a trial primarily focuses on safety and effectiveness, is dose- ranging and occurs in subjects with the disease or condition under study? a. phase 1 b. phase 2 c. phase 3 d. phase 4 - Correct Answer ✅b Quality documentation practices ALCOAC. What does this stand for? - Correct Answer ✅Attributable Legible
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Contemporaneous Original Accurate Complete After a new drug application is approved, the responsibility for reporting safety issues to the FDA rests with a. the irb b. the sponsor c. the principal investigator d. the clinical research coordinator - Correct Answer ✅b To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? a. clinical research associate laboratory and other related vendors
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The sponsor has how many days to report a non-fatal IND safety report to the FDA? - Correct Answer ✅15 calendar days What are examples of hidden costs in a study budget? a. monthly rent payment b. scheduled study visits c. unexpected equipment failure d. IRB submission fee - Correct Answer ✅c The four types of monitoring visits are? - Correct Answer ✅Qualification initiation routine close-out When is the New Drug Application (NDA) submitted? - Correct Answer ✅at the end of Phase 3 trials
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A document that describes the objective(s), design, methodology, statistical considerations and organization of a trial is a: a. protocol b. monitoring plan c. investigator agreement d. information sheet - Correct Answer ✅a Which phase of trial primarily focuses on confirming effectiveness and establishing a safety profile in subjects with the disease or condition and other concurrent illnesses and medications? a. phase 1 b. phase 2 c. phase 3 d. phase 4 - Correct Answer ✅c Which of the following are possible methods of recruiting study subjects?
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d. reconstruction of events by auditors, monitors and regulatory inspectors - Correct Answer ✅a Who is responsible for reviewing and approving advertising used for subject recruitment? a. irb b. sponsor c. principal investigator d. clinical research coordinator - Correct Answer ✅a A study budget must be: a. unlimited b. finalized by the FDA c. very strict d. somewhat flexible - Correct Answer ✅d
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The research staff that conducts the informed consent discussion and signs the informed consent form must be a. a RN, LPN, NP or MD b. trained and delegated c. qualified, trained, and delegated d. a BS, BA, MD or PhD - Correct Answer ✅c ICH GCP E6 R2 states that informed consent is documented by means of a: a. written and dated informed consent form b. written and signed informed consent form c. written, signed and dated informed consent form d. written, initialed and signed informed consent form - Correct Answer ✅c Case report forms (CRFs) are typically developed by the ____ and the ____ performs source document verification - Correct Answer ✅sponsor; CRA
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c. a major cerebrovascular accident or stroke d. contact dermatitis treated with over the counter meds - Correct Answer ✅c The FDA center that ensures the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application is known as: - Correct Answer ✅BIMO Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment is called an - Correct Answer ✅AE The definition of an unanticipated adverse device effect (UADE) is that i tmust be serious, related and unexpected. how does this differ from the definition of a serious adverse event (SAE)? a. there is no difference, an sae must also be serious, related and unexpected
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b. an sae must be serous and related to the study drug, but it may be expected c. an sae must be serious and unexpected, but it may or may not be related to the study drug d. an SAE must only meet serious criteria; relatedness an - Correct Answer ✅d Examples of variable costs include a. wages, IRB fees and equipment b. wages, staffing and equipment c. wages, overhead and indirect costs, IRB fees d. wages, materials and subject reimbursement - Correct Answer ✅d Whom should the sponsor notify of findings that affect the safety of the subjects? a. all participating investigators and study coordinators b. all participating investigators and the regulatory authority
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identify the most underestimated costs in a study budget - Correct Answer ✅time what is the primary difference between an AE and an adverse drug reaction (ADR)? - Correct Answer ✅an ADR is always related to the study drug and an AE may or may not be related to the study drug What is the key document used when assessing "expectedness" of an AE or ADR? - Correct Answer ✅investigator brochure the fda center responsible for regulating over the counter and prescription drugs, including generic drugs is: - Correct Answer ✅CDER A subject enters the study witha hx of mild dyspepsia (heartburn) that is managed with OTC antacids. after a week of starting study drug, the subject's heartburn becomes severe and requires a prescription medication. how must site staff report and record this?
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a. this is not an AE since the subject entered the study with the condition. only the con med log requires updating b. this is not an AE, but the medical history and con med log need to be updated c. this is an AE since it is a worsening - Correct Answer ✅c at what frequency does an IRB need to conduct continuing review of each clinical trial? a. set frequency of once per year, regardless of the degree of risk to human subjects b. set frequency of every six months, regardless of the degree of risk to human subjects c. intervals appropriate to the degree of risk to human subjects, but at least once per year d. intervals appropriate to the degree of risk to human subjects, but at least every six months - Correct Answer ✅c The purpose of the ____ is to document qualifications and eligiblity to conduct a trial and/or provide medical supervision of subjects
