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ACRP CCRC 500 Exam Questions and Answers

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c) Is not necessarily causally related to drug - ANSWER An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessarily causally related to drug ... d) Is life threatening d) a and b - ANSWER An adverse event is one which a) Is an unfavorable and unintended sign, symptom or disease b) Is one that is temporally associated with drug regardless of whether it is related or not c) a only d) a and b a) An adverse event - ANSWER A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is most likely classified as a) An adverse event b) An adverse drug reaction c) An unexpected adverse drug reaction d) A serious adverse event b) A causal relationship between drug and adverse event is a reasonable possibility c) The relationship of the event to drug cannot be ruled out - ANSWER A response to a medical product means (check all options that apply) a) A causal relationship between drug and adverse event is established b) A causal relationship between drug and adverse event is a reasonable possibility c) The relationship of the event to drug cannot be ruled out d) An event that requires active medical intervention b) A noxious and unintended response to a drug - ANSWER An adverse drug reaction is one which a) Results in death or hospitalization b) A noxious and unintended response to a drug c) Occurs frequently and with greater severity than usual d) Likely occurs at normal doses of the drug d) a and b - ANSWER For a drug that is in a Phase IV trial and adverse drug reaction is one which a) Is noxious and unintended b) Occurs at normal doses used for prophylaxis c) a only d) a and b e) All of the above - ANSWER A serious adverse event is on which results in a) Death or life threatening event b) A hospitalization or prolongation of hospitalization c) Persistent or significant disability d) Congenital anomaly or birth defect e) All of the above b) An event where risk of death was evident at the time of the event - ANSWER The term, life threatening, in a serious adverse event refers to a) An event which required hospitalization b) An event where risk of death was evident at the time of the event c) An event that required treatment in an emergency room d) An event which might have caused a death if left untreated d) a and b - ANSWER An event may be classified as serious if it a) Not immediately life threatening, but may jeopardize the patient b) Not immediately life threatening but may require and intervention to prevent hospitalization c) a only d) a and b d) May be considered serious and should be considered for expedited reporting - ANSWER A patient in a clinical I trial for joint pain experiences a bronchospasm while at home. The event would be a) Not reportable because it occurred in a home setting b) An adverse event which does not require reporting c) An unexpected adverse event which does not require expedited reporting d) May be considered serious and should be considered for expedited reporting d) All of the above - ANSWER Events which may be classified as serious even though they do not result in hospitalization include a) Allergic bronchospasm b) Blood dyscrasias c) Convulsions d) All of the above b) Not mentioned in the investigator's brochure or relevant source document - ANSWER An unexpected adverse reaction is one which is a) Not expected by the investigator b) Not mentioned in the investigator's brochure or relevant source document c) Classified as such by the IRB d) Classified as such by the sponsor's medical safety officer d) All of the above - ANSWER Which of the following is an unexpected adverse event? a) A report which adds significant information to an already documented serious adverse event b) A report of interstitial nephritis in a patient with acute renal failure c) A report of fulminant hepatitis in patient with an initial report of hepatitis d) All of the above b) Serious and unexpected - ANSWER For expedited reporting an event must be a) Serious b) Serious and unexpected c) Only temporally associated with drug administration d) Causally related to drug administration c) Submitted to the appropriate regulatory authority on an expedited basis - ANSWER According to ICH serious unexpected reaction to a drug should be a) Submitted to the appropriate regulatory authority within one week b) Submitted to the appropriate regulatory authority within 15 days c) Submitted to the appropriate regulatory authority on an expedited basis d) Submitted promptly to the IRB a) Root cause analysis - ANSWER Clinical investigation of adverse events in clinical trials requires a) Root cause analysis b) Complete medical records review c) Investigation of potential protocol deviations d) Causality assessment d) Causality - ANSWER Adverse events of marketed drugs usually imply a) Multi-drug interactions b) Unreliable subjective measures c) Psychosomatic factors d) Causality d) All of the above - ANSWER Rapid communication of single case reports of serious adverse events is merited if the information a) Influences risk benefit assessment b) Implies a change need in drug administration c) A change in the conduct of the clinical investigation d) All of the above d) All of the above - ANSWER Expedited reporting of serious adverse events may be considered if a) There is an increased rate of occurrence in the serious adverse drug reaction b) A lack of efficacy is evident in treating a life-threatening disease c) A new safety consideration is evident from a new animal study d) All of the above a) No later than 7 days after first knowledge of event c) By filing a complete report within 8 additional days of the initial notification - ANSWER Fatal or life threatening and unexpected adverse drug reactions in clinical investigations should be reported to the regulatory agencies (check all that apply) a) No later than 7 days after first knowledge of event b) No later than 15 days after first knowledge of event c) By filing a complete report within 8 additional days of the initial notification d) By filing a complete report within 15 additional days of the initial notification c) As soon as possible, but not later than 15 days of first knowledge - ANSWER Serious adverse drug reactions must be filed with regulatory agencies a) As soon as possible, but not later than 8 days of first knowledge b) As soon as possible, but not later than 10 days of first knowledge c) As soon as possible, but not later than 15 days of first knowledge d) As soon as possible, but not later than 1 month of first knowledge b) Care should be taken to break the blind only for the single patient involved - ANSWER In ascertaining the basis for a serious adverse drug reaction in a randomized trial a) Care should be taken not to break the blind for the patient b) Care should be taken to break the blind only for the single patient involved c) The blind for the group of patients being treated at the site should be broken d) The blind for the single patient should be broken only if the sponsor approves b) Has little or no significant implication for the investigation or final data analysis - ANSWER Breaking the blind for a single patient in randomized clinical trial a) Has negative implications for data integrity at the site level b) Has little or no significant implication for the investigation or final data analysis c) May compromise drug approval because of implications for final data analysis d) Provides no significant information regarding the safety of the patient d) a and b - ANSWER Adverse drug reactions in the control group should be reported to a) The other manufacturer b) Appropriate regulatory agency c) a only d) a and b d) All of the above - ANSWER An adverse reaction occurs in patients after the study has been completed. The appropriate action on the part of the investigator include a) Report the event to the sponsor b) Consider the event for reporting as though it was a study report c) Conduct causality assessment and determination of expectedness prior to expedited reporting d) All of the above d) Updating the Investigator's Brochure - ANSWER New safety information regarding a study drug should be updated by the sponsor by a) Notifying the IRB b) Notifying the investigator c) Updating the protocol d) Updating the Investigator's Brochure b) Is inconsistent with the documented product information in the investigator's brochure or other source document - ANSWER An unexpected adverse drug reaction is a reaction a) Happens immediately after drug administration b) Is inconsistent with the documented product information in the investigator's brochure or other source document c) Known to occur frequently in preclinical studies d) Dependent on the dose the drug c) May not meet the definition of a serious adverse event - ANSWER An adverse event that is severe in intensity a) May qualify for expedited reporting b) Could be classified as a serious adverse event c) May not meet the definition of a serious adverse event d) Need not be reported to the sponsor if it is part of the disease condition d) That merely describes the intensity of the medical event - ANSWER To be characterized as severe an adverse event is one a) That qualifies for expedited reporting b) Is always life threatening c) Is always one that can be characterized as serious d) That merely describes the intensity of the medical event d) None of the above - ANSWER Which of the following statements is correct? a) An adverse event is one that is always viewed as potentially serious b) An adverse event is an adverse drug reaction c) An adverse event qualifies for expedited reporting d) None of the above c) Has a reasonable suspected causal relationship to the drug - ANSWER An adverse drug reaction is one which a) Always associated with a hospitalization b) Qualifies for expedited reporting c) Has a reasonable suspected causal relationship to the drug d) Can usually be characterized as severe c) A serious adverse drug reaction - ANSWER In a clinical trial of congestive heart failure a hospitalization for one day until acute symptoms resolve is considered usual. Patient X was hospitalized for a period for five days. This event a) Is an adverse event b) Unexpected adverse drug reaction c) A serious adverse drug reaction d) Cannot be characterized as serious as it is reflective of the disease and not the drug d) All of the above - ANSWER A serious adverse event which has resulted in death requires a) An autopsy report b) A detailed account of relationship to drug c) A definitive exclusion of the effects of concomitant drugs d) All of the above ICH E2A - ANSWER What ICH Guideline is the Clinical Safety Data Management? a) Declaration of Helsinki - ANSWER The ethical principles underlying clinical study management are stated in a) Declaration of Helsinki b) Belmont report c) Nuremberg Code d) CIOMS guidelines c) Studies in animal models - ANSWER The term non-clinical studies refers to a) Studies in vitro cell culture models b) Studies in organ culture c) Studies in animal models d) Pilot human studies c) Should be sufficient to indicate safety in human studies - ANSWER Nonclinical studies a) Should be performed in at least three species b) Must include a disease animal model c) Should be sufficient to indicate safety in human studies d) Are not needed before some human studies d) a and b - ANSWER Toxicology studies in animal models a) Should be reviewed by qualified experts b) Assessed for their implications of subject safety c) a only d) a and b c) Sound scientific design - ANSWER Clinical trial protocols should reflect a) Reasonable costs for the clinical trial b) Minimize sample sizes to reduce risks c) Sound scientific design d) The use of control groups whenever possible d) All of the above - ANSWER The responsibility for the protection of clinical trial subjects rests with a) IRB/IEC b) Investigator c) Sponsor d) All of the above a) Phase I - ANSWER ICH defined Human pharmacology trial are a) Phase I b) Phase II c) Phase III d) Phase IV b) Phase II - ANSWER ICH defined Therapeutic Exploratory studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV c) Phase III - ANSWER ICH defined Therapeutic Confirmatory studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV d) Phase IV - ANSWER ICH defined Therapeutic Use studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV a) Human Pharmacology - ANSWER Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be a) Human Pharmacology b) Therapeutic Exploratory c) Therapeutic Confirmatory d) Therapeutic use d) Continue throughout the development plan - ANSWER Characterization of drug's absorption, metabolism and excretion a) Are confined to Phase I studies b) Can be conducted in Phase II studies if Phase I studies are inconclusive c) Are never studied in Phase Ill studies d) Continue throughout the development plan d) b only - ANSWER Studies which provide the most information for confirmatory study design are part of a) Phase I studies b) Phase II studies c) a only d) b only b) Phase II - ANSWER Trials of short duration in narrow patient populations using pharmacological endpoints or clinical measures are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV c) Phase III - ANSWER Studies which provide the most information for risk benefit relationship of a drug are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV d) Phase IV - ANSWER Studies on which marketing approval hinges are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV d) Phase IV - ANSWER Epidemiologic and pharmacoeconomic studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV d) All of the above - ANSWER Considerations for determining the nature and timing of non-clinical studies include a) Duration and total exposure prosed in individual patients b) Long half life c) Route of administration d) All of the above d) All of the above - ANSWER For first in human studies the administered dose should be determined by a) Pharmacokinetics b) Drug pharmacology c) Toxicological evaluations d) All of the above d) Comparative bioavailability studies - ANSWER Pharmacokinetic studies include all except a) Dose response studies b) Absorption, distribution and metabolism studies c) Studies of the route of administration d) Comparative bioavailability studies b) Bioavailability - ANSWER Formulations of the drug should be characterized on a) Maximum tolerated dose b) Bioavailability c) Half-life d) Drug clearance b) Elderly - ANSWER Special populations to be considered in clinical trial is defined in ICH ES to include all except a) Pregnant women b) Elderly c) Nursing women d) Children d) All of the above - ANSWER Study objectives in clinical trial design may include a) Safety and efficacy characterization b) Pharmacokinetic and pharmacological studies c) Physiological and biochemical studies d) All of the above a) Cost assessment of proposed clinical trial - ANSWER Study design considerations should include all of the following except a) Cost assessment of proposed clinical trial b) Primary and secondary endpoints and associated analyses c) Methods to monitor adverse events d) Use of appropriate comparators and adequate sample size d) All of the above - ANSWER Which of the following statements is true a) Trial subjects should not enroll in more than one trial at any given time b) Women of childbearing potential should use highly effective contraception measures c) Male subjects should be made aware of hazard of drug exposure to their sexual partners or progeny d) All of the above a) A group of a distinct age composition - ANSWER A control group may consist of all of the following except a) A group of a distinct age composition b) A placebo c) Active control d) Different doses of the drug a) Clinical trial logistics and cost controls - ANSWER Statistical assessment of sample size should include assessments of all of the following except a) Clinical trial logistics and cost controls b) Treatment effect and data variability c) Probability of error d) Information in population subsets or secondary endpoints b) Exclude safety considerations - ANSWER Primary endpoints should have all of the following features except a) Reflect clinically relevant effects b) Exclude safety considerations c) Be based on the principal objective d) Be clearly distinguishable from secondary endpoints d) Qualitative - ANSWER Measurements of subjective and objective endpoints should be all of the following except a) Accurate and precise b) Reproducible and reliable c) Responsive d) Qualitative d) All of the above - ANSWER Methods to minimize bias include a) Randomization b) Blinding c) Compliance measures d) All of the above a) A section for assessment of conflict of interest - ANSWER The protocol should include all of the following except a) A section for assessment of conflict of interest b) Analysis plan appropriate to objectives and design c) Statistical methods d) Plans for interim analysis d) Approved use by the regulatory agency - ANSWER Phase IV protocols generally follow a) Phase I protocols b) Phase II protocols c) Phase III protocols d) Approved use by the regulatory agency a) Study endpoints - ANSWER Response variables are closely related to a) Study endpoints b) Primary objectives c) Secondary Objectives [Show More]

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