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Ethical Principles and Regulatory Guidelines in Clinical Study Management, Exams of Nursing

This document provides an overview of the key ethical principles and regulatory guidelines that govern the management of clinical studies. It covers topics such as the Declaration of Helsinki, Belmont Report, Nuremberg Code, and CIOMS guidelines, which establish the ethical framework for conducting clinical trials. It also discusses the different phases of clinical development, study design considerations, and the role of regulatory authorities and review boards.

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2023/2024

Available from 09/15/2024

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Download Ethical Principles and Regulatory Guidelines in Clinical Study Management and more Exams Nursing in PDF only on Docsity! ACRP CCRC Exam (NEW 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Graded A QUESTION The ethical principles underlying clinical study management are stated in a) Declaration of Helsinki b) Belmont report c) Nuremberg Code d) CIOMS guidelines Answer: a) Declaration of Helsinki QUESTION 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 Answer: c) Studies in animal models QUESTION 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 Answer: c) Should be sufficient to indicate safety in human studies QUESTION 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 Answer: d) a and b QUESTION 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 Answer: c) Sound scientific design QUESTION The responsibility for the protection of clinical trial subjects rests with a) IRB/IEC b) Investigator c) Sponsor d) All of the above Answer: d) All of the above QUESTION ICH defined Human pharmacology trial are a) Phase I b) Phase II c) Phase III d) Phase IV Answer: a) Phase I QUESTION ICH defined Therapeutic Exploratory studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV Answer: QUESTION Epidemiologic and pharmacoeconomic studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV Answer: d) Phase IV QUESTION Considerations for determining the nature and timing of non-clinical stud- ies include a) Duration and total exposure prosed in individual patients b) Long half life c) Route of administration d) All of the above Answer: d) All of the above QUESTION 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 Answer: d) All of the above QUESTION 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 Answer: d) Comparative bioavailability studies QUESTION Formulations of the drug should be characterized on a) Maximum tolerated dose b) Bioavailability c) Half-life d) Drug clearance Answer: b) Bioavailability QUESTION 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 Answer: b) Elderly QUESTION 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 Answer: d) All of the above QUESTION 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 Answer: a) Cost assess- ment of proposed clinical trial QUESTION 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 Answer: d) All of the above QUESTION 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 Answer: a) A group of a distinct age composition QUESTION 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 Answer: a) Clinical trial logistics and cost controls QUESTION 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 Answer: b) Exclude safety considerations 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 Answer: d) All of the above QUESTION 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 notifica- tion Answer: 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 QUESTION 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 Answer: c) As soon as possible, but not later than 15 days of first knowledge QUESTION In ascertaining the basis for a serious adverse drug reaction in a random- ized 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 Answer: b) Care should be taken to break the blind only for the single patient involved QUESTION 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 Answer: b) Has little or no significant implication for the investigation or final data analysis QUESTION 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 Answer: d) a and b QUESTION 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 Answer: d) All of the above QUESTION 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 Answer: d) Updating the Investigator's Brochure QUESTION An unexpected adverse drug reaction is a reaction a) Happens immediately after drug administration b) Is inconsistent with the documented product information in the investiga- tor's brochure or other source document c) Known to occur frequently in preclinical studies d) Dependent on the dose the drug Answer: b) Is inconsistent with the documented product information in the investigator's brochure or other source document QUESTION 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 Answer: c) May not meet the definition of a serious adverse event QUESTION 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 Answer: d) That merely describes the intensity of the medical event QUESTION 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 b) Sub- jects with cancer QUESTION Methods to be used in assessing patient drug use and compliance are best a) Discussed verbally with the subject b) Need not be mentioned in the informed consent c) Need not be discussed with subjects d) Included in the study protocol Answer: d) Included in the study protocol QUESTION Planning of clinical trials with children a) Should await the results of a trials in adults b) Should be planned with children in mind from the very outset c) Should exclude children ages d) Should be planned predominantly in adolescents Answer: b) Should be planned with children in mind from the very outset QUESTION What ICH Guideline is the Statistical Principles in Clinical Trials Answer: ICH E9 QUESTION The primary concern in a confirmatory trial is a) Efficacy b) Safety c) Pharmacodynamics d) Pharmacokinetics Answer: a) Efficacy QUESTION Statistical principles are relevant to a) Phase I trials b) Phase II trials c) Phase 111 trials d) All of the above Answer: d) All of the above QUESTION Statistical principles are relevant to a) Phase I trials b) Phase II trials c) Phase III trials d) All of the above Answer: d) All of the above QUESTION Factors associated with bias can include a) Study design b) Study conduct c) Data analysis and interpretation d) All of the above Answer: d) All of the above QUESTION Robustness refers to all of the following except a) Sensitivity of the conclusions to various limitations of data b) Sensitivity to the conclusions data to various limitations of assumptions c) Lack of an effect of study conclusions to alternative analytic approaches d) The health status of the subjects in the clinical trial Answer: d) The health status of the subjects in the clinical trial QUESTION Bias is defined as a) Error in miscalculation of the final drug effect b) Trend to extrapolation in missing values c) Deviation in the estimation of a treatment effect from its true value d) Failure to use a complete data set for analysis Answer: c) Deviation in the estimation of a treatment effect from its true value QUESTION A development plan purpose is to a) Find a dose range that is simultaneously safe and effective b) Prove that the risk benefit relationship is acceptable c) Identify the subjects who would most benefit and indications for the use d) All of the above Answer: d) All of the above QUESTION In a confirmatory trial the following apply a) Phase 1 results are verified in phase 2 trials b) Test the key hypothesis, effect size and clinical significance c) Conduct the trial in a large sample of subjects d) The design is that described for the use of an approved drug Answer: b) Test the key hypothesis, effect size and clinical significance QUESTION Exploratory trials (select all that apply) a) Explore a wide range of hypotheses b) Provide formal proof of efficacy c) Need flexible designs d) Are designed to explore new uses for an approved drug Answer: a) Explore a wide range of hypotheses c) Need flexible designs QUESTION QUESTION In a single blind trial the person who is unaware of the treatment is a) Subject b) Investigator c) Monitor d) Clinical coordinator Answer: a) Subject QUESTION In an open label trial the persons who should be aware that the treatment is being administered are a) Subject and investigator b) Pharmacist and investigator c) Sponsor and investigator d) Monitor and investigator Answer: a) Subject and investigator QUESTION Breaking the blind for a single subject a) Implies breaking the blind for the study group b) May be done at the discretion of the monitor c) Should be implemented when deemed essential for subject's care d) Always involves a serious adverse event Answer: c) Should be implemented when deemed essential for subject's care QUESTION In a parallel group design the subjects a) Randomized to two arms each with a different treatment b) Are evaluated before and after drug administration c) Are randomized to a sequence of two treatments d) Are evaluated simultaneously for varying combinations of treatments Answer: a) Randomized to two arms each with a different treatment QUESTION In a crossover design the subjects a) Randomized to two arms each with a different treatment b) Are evaluated before and after drug administration c) Are randomized to a sequence of two treatments d) Are evaluated simultaneously for varying combinations of treatments Answer: c) Are randomized to a sequence of two treatments QUESTION In a pre- post design the subjects a) Randomized to two arms each with a different treatment b) Are evaluated before and after drug administration c) Are randomized to a sequence of two treatments d) Are evaluated simultaneously for varying combinations of treatments Answer: b) Are evaluated before and after drug administration QUESTION In a factorial design the subjects a) Randomized to two arms each with a different treatment b) Are evaluated before and after drug administration c) Are randomized to a sequence of two treatments d) Are evaluated simultaneously for varying combinations of treatments Answer: d) Are evaluated simultaneously for varying combinations of treatments QUESTION What ICH Guideline is the General Considerations for Clinical Trials? Answer: ICH E8 QUESTION The most commonly used study design in clinical trials is: a) Parallel design b) Crossover design c) Pre-Post design d) Factorial design Answer: a) Parallel design QUESTION For a successful crossover design: a) Carryover from a pervious treatment should be minimized b) The disease should be chronic and stable c) Drug effects should develop fully within the treatment period d) All of the above Answer: d) All of the above QUESTION What does OHRP stand for? Answer: Office for Human Research Protection QUESTION What does DHHS stand for? Answer: Department of Human and Health Services QUESTION What does FWA for? Answer: Federal Wide Assurance (for protection of human sub- jects) QUESTION A placebo controlled trial would be considered unethical if a) The drug has been shown to be efficacious in a superiority trial b) The drug has been shown equivalent to active control in a non-inferiority trial c) Drug has shown serious side effects in preclinical studies d) All of the above Answer: a) The drug has been shown to be efficacious in a superiority trial QUESTION An equivalence or non-inferiority trial is one in which a) Efficacy of a test drug is no worse than an active comparator b) Multiple doses of a test drug are compared to multiple doses of as standard drug c) a only d) a and b Answer: d) a and b QUESTION An active control is best represented by a) Any drug that has shown activity against the disease b) A drug that has been shown to be non-inferior in an equivalence trial c) A drug that has shown efficacy in a superiority trial d) All of the above Answer: c) A drug that has shown efficacy in a superiority trial QUESTION In assessing sample size the items that need to be specified include all except a) The primary variable and test statistic b) The null and alternative hypothesis c) The projected cost of the trial for the designated sample size d) Type I and Type II errors Answer: c) The projected cost of the trial for the designated sample size QUESTION The probability of erroneously rejecting the null hypothesis is described as a) Type I error b) Type II error c) Type III error d) Risk assessment Answer: a) Type I error QUESTION The probability of erroneously failing to reject the null hypothesis is described as a. Type I error b. Type II error c. Type III error d. Risk assessment Answer: b. Type II error QUESTION Data collection in a clinical trial usually employs a) Paper case record forms b) Remote site monitoring c) Medical computer systems and electronic transfer d) All of the above Answer: d) All of the above QUESTION The type of monitoring in a confirmatory clinical trial may include a) Oversight of the quality of the clinical trial b) Breaking the blind for treatment comparison and interim analysis c) a only d) a and b Answer: d) a and b QUESTION Oversight of the quality of a trail involves review of all of the following except a) Protocol adherence b) Conflict of interest c) Patient accrual and retention d) Review of design assumptions Answer: b) Conflict of interest QUESTION Inclusion and exclusion criteria a) Can be set to maximize enrollment b) Are independent of preclinical studies c) Should remain constant during a clinical trial d) May change as needed during a clinical trial Answer: c) Should remain constant during a clinical trial QUESTION The ideal data analysis set is one in which a) Procedures are followed perfectly b) Data records are complete c) There is no loss to patient follow up d) All of the above Answer: d) All of the above QUESTION Irregularities in the data analysis set may arise from a) Protocol violations b) Patient withdrawals c) Missing values d) All of the above Answer: d) All of the above QUESTION The intention to treat analysis set includes a) All treated subjects b) Only subjects with complete drug treatments Answer: d) Between trial comple- tion and breaking of the blind QUESTION The term double dummy refers to a) Double blinded trial b) Placebo controlled trial c) Technique to retain the blind when administering supplies to non-identical groups d) All of the above Answer: c) Technique to retain the blind when administering supplies to non-identical groups QUESTION The DSMB monitors a) The safety data b) Patient accrual c) Data accuracy d) Missing data Answer: a) The safety data QUESTION The DSMB can recommend a) Continuation, modification or termination of a sponsor's trial b) The continued enrollment of patients in light of safety events c) The submission of serious adverse safety events for regulatory review d) The submission of serious adverse safety events to the IRB Answer: a) Continuation, modification or termination of a sponsor's trial QUESTION Methods to avoid the bias in a clinical trial generally involve a) Single-blind only b) Double-blind only c) Single or double blind d) Open label Answer: c) Single or double blind QUESTION A trial designed on the basis of some evidence of benefits is likely to be a) Exploratory trial b) Confirmatory trial c) Phase IV trial Open label trial Answer: b) Confirmatory trial QUESTION Mutlicenter trials can be implemented for a) Open label trials b) Exploratory trials c) Confirmatory trials d) Any stage of clinical drug development Answer: d) Any stage of clinical drug develop- ment QUESTION What GCP ICH is the Clinical Investigation of Pediatric Population? Answer: ICH E11 QUESTION The decision to proceed with a pediatric drug development program includes all of the following except a) Prevalence and seriousness of the condition b) The availability and suitability of alternative treatment c) The adverse event profile of alternative treatments d) Results of phase I trials in adults Answer: d) Results of phase I trials in adults QUESTION The decision to proceed with a pediatric drug development program includes all of the following except a) Novel or unique features of the proposed drug b) The age ranges of the likely pediatric patients c) Non clinical safety issues and implications for formulation development d) Pilot studies in a small relevant group of children Answer: d) Pilot studies in a small relevant group of children QUESTION Formulation of pediatric drugs may require the need for a) Chewable tablets and liquid formulations b) Safe and easily injectable formulations c) Frequent use of suspensions d) All of the above Answer: d) All of the above QUESTION The timing of pediatric studies of a drug is dependent on a) Completion of Phase 1 trials in adults b) Successful non clinical studies c) Type of disease and safety and efficacy of alternate treatments d) Known safety profile of the drug in the adult population Answer: c) Type of disease and safety and efficacy of alternate treatments QUESTION Development of drug for a disease exclusively affecting the pediatric population requires a) The entire development program in children only b) Safety and tolerability data obtained in adults c) a only d) a and b c) Infants and toddlers d) All of the above Answer: d) All of the above QUESTION The definition of a child as classified by age in the United States a) Is specified in the Federal regulations b) Is designated as being the same in countries that are signatories to ICH guidelines c) Varies by state in the United States d) Is set at 18 years as a universal standard Answer: c) Varies by state in the United States QUESTION 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 Answer: c) Is not necessarily causally related to drug QUESTION 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 Answer: d) a and b QUESTION 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 Answer: a) An adverse event QUESTION 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 Answer: 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 QUESTION 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 Answer: b) A noxious and unintended response to a drug QUESTION 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 Answer: d) a and b QUESTION 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 Answer: e) All of the above QUESTION 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 Answer: b) An event where risk of death was evident at the time of the event QUESTION 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 Answer: d) a and b QUESTION 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 report- ing Answer: