ACRP CCRC Study Guide Questions With 100% Correct Answers | Verified | Updated 2024, Exams of Advanced Education

Download ACRP CCRC Study Guide Questions With 100% Correct Answers | Verified | Updated 2024 and more Exams Advanced Education in PDF only on Docsity! ACRP CCRC Study Guide Questions With 100% Correct Answers | Verified | Updated 2024 What is ICH E2A? Clinical Safety Data Management -Definitions and Standards for Expedited Reporting -This document gives standard definitions and terminology for key aspects of clinical safety reporting. -It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development. ICH E2A: 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 c) Is not necessarily causally related to drug ICH E2A: 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 d) a and b 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 ICH E2A: 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 a) An adverse event ICH E2A: 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 causal relationship between drug and adverse event is a reasonable possibility c) The relationship of the event to drug cannot be ruled out ICH E2A: 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 b) A noxious and unintended response to a drug ICH E2A: For a drug that is in a Phase IV trial an 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 d) a and b a) Is noxious and unintended b) Occurs at normal doses used for prophylaxis ICH E2A: 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 e) All of the above ICH E2A: 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 b) An event where risk of death was evident at the time of the event ICH E2A: 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 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 c) As soon as possible, but not later than 15 days of first knowledge ICH E2A: In ascertaining (to find out) 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) Care should be taken to break the blind only for the single patient involved ICH E2A: 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 b) Has little or no significant implication for the investigation or final data analysis ICH E2A: 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) a and b ICH E2A: 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) All of the above ICH E2A: 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 d) Updating the Investigator's Brochure ICH E2A: 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 b) Is inconsistent with the documented product information in the investigator's brochure or other source document What does OHRP stand for? Office for Human Research Protection What does DHHS stand for? Department of Human and Health Services What does FWA stand for? Federal Wide Assurance (for protection of human subjects) What does DSMB stand for? Data Safety Monitoring Board What does DSMP stand for? Data and Safety Monitoring Plan What does WMA stand for? World Medical Association What does IND stand for? Investigational New Drug What does IDE stand for? Investigation Device Exemption What does PMA stand for? Pre-Market Approval What does HUD stand for? Humanitarian Use Device What does HDE stand for? Humanitarian Device Exemption What does CIOC stand of? Conflict of Interest Committee ICH E2A: 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 c) May not meet the definition of a serious adverse event What is the normal limit for the AST test liver function? 5 ICH E2A: 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) That merely describes the intensity of the medical event ICH E2A: 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 d) None of the above ICH E2A: 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) Has a reasonable suspected causal relationship to the drug ICH E2A: 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 c) A serious adverse drug reaction ICH E2A: 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 c) Therapeutic Confirmatory d) Therapeutic use a) Human Pharmacology ICH E8: 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 III studies d) Continue throughout the development plan d) Continue throughout the development plan ICH E8: 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 d) b only ICH E8: 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 b) Phase II ICH E8: 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 c) Phase III ICH E8: Studies on which marketing approval hinges are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV c) Phase III ICH E8: Epidemiologic and pharmacoeconomic studies are likely to be a) Phase I b) Phase II c) Phase III d) Phase IV d) Phase IV ICH E8: 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 ICH E8: 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) All of the above ICH E8: 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 d) Comparative bioavailability studies Comparative bioavailability studies are small studies compared to other clinical trials. One or two extreme values could have a large effect on the inference to be made from these small studies. The usual parametric assumptions and estimation are not robust against extreme values. ICH E8: Formulations of the drug should be characterized on a) Maximum tolerated dose b) Bioavailability C) Half-life d) Drug clearance b) Bioavailability Bioavailability is the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect. ICH E8: Special populations to be considered in clinical trial is defined in ICH E8 to include all except a) Pregnant women b) Elderly c) Nursing women d) Children b) Elderly ICH E8: 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 d) All of the above ICH E8: 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 a) Cost assessment of proposed clinical trial What does SMO stand for? Site Management Organization ICH E8: 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 d) All of the above ICH E8: 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) A group of a distinct age composition ICH E8: 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 a) Clinical trial logistics and cost controls ICH E8: Primary endpoints should have all of the following features except a) Reflect clinically relevant effects a) Efficacy ICH E9: Statistical principles are relevant to a) Phase I trials b) Phase II trials c) Phase III trials d) All of the above d) All of the above ICH E9: 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 c) Deviation in the estimation of a treatment effect from its true value ICH E9: Factors associated with bias can include a) Study design b) Study conduct c) Data analysis and interpretation d) All of the above d) All of the above ICH E9: 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 d) The health status of the subjects in the clinical trial ICH E9: 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 d) All of the above ICH E9: In a confirmatory trial the following apply a) Phase I results are verified in phase II 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 b) Test the key hypothesis, effect size and clinical significance ICH E9: 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 a) Explore a wide range of hypotheses c) Need flexible designs ICH E9: The population of a clinical trial reflects all of the following except a) May be narrow in early trials to maximize effects b) Tend to mirror the target disease population in later trials c) Is always significantly large in Phase 1 trials to ensure reliable toxicology results d) Must balance eligibility criteria and treatment effects c) Is always significantly large in Phase 1 trials to ensure reliable toxicology results ICH E9: The primary variable reflects all of the following except a) Must provide convincing evidence for the primary objective b) Is usually the efficacy variable c) Must provide significant support for secondary variables d) May be restricted in some trials only to safety and tolerability c) Must provide significant support for secondary variables ICH E9: Secondary variables must a) Be supportive measurements related to the primary objective b) Need to have their role and importance defined carefully in a clinical trial c) Should be limited to answering a limited number of questions in the trial d) All of the above d) All of the above ICH E9: Global assessment variables reflect all of the following except a) They are developed to measure the overall usefulness of treatment b) Require that a scale be developed and detailed in the protocol c) Should define how to assign subjects to a unique category on a scale d) Are never used as a primary variable in most clinical trials d) Are never used as a primary variable in most clinical trials ICH E9: Which of the following statements regarding surrogate variables is false? a) They are used when direct observation of clinical efficacy is not practical b) May show an effect in the absence of a clinical outcome c) May not yield a quantitative measure of clinical benefit d) Often allow for an assessment of benefits relative to adverse effects d) Often allow for an assessment of benefits relative to adverse effects ICH E9: For a surrogate variable to be reliable, they should a) Have a plausible relationship to clinical outcome b) Be supported by epidemiologic evidence c) Reflect a treatment effect that corresponds to clinical outcome d) All of the above d) All of the above ICH E9: A double blind trial is one in which the following are unaware of the treatment received a) Sponsor b) Investigator c) Subject d) All of the above d) All of the above ICH E9: In a double blind trial the person who should be unaware of the treatment should not be involved in assessing a) Eligibility b) Endpoints c) Compliance d) All of the above d) All of the above ICH E9: In a single blind trial the person who is unaware of the treatment is a) Subject b) Investigator c) Monitor d) Clinical coordinator a) Subject ICH E9: 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 a) Subject and investigator ICH E9: 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 c) Should be implemented when deemed essential for subject's care c) A drug that has shown efficacy in a superiority trial ICH E9: 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 c) The projected cost of the trial for the designated sample size ICH E9: 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 a) Type I error ICH E9: 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 b) Type II error ICH E9: 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 d) All of the above -a thing that persuades or influences someone to do something; incentive, stimulus, lure -bribe inducement ICH E9: 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 d) a and b ICH E9: Oversight of the quality of a trial 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 b) Conflict of interest ICH E9: 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 c) Should remain constant during a clinical trial ICH E9: 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 d) All of the above ICH E9: Irregularities in the data analysis set may arise from a) Protocol violations b) Patient withdrawals c) Missing values d) All of the above d) All of the above ICH E9: The intention to treat analysis set includes a) All treated subjects b) Only subjects with complete drug treatments c) Subjects who have undergone the minimum number of acceptable trial visits d) All randomized subjects d) All randomized subjects ICH E9: The Per protocol analysis data set includes a) All randomized subjects b) All subjects who have not undergone SAEs c) Evaluable subjects compliant with the protocol d) Subjects with no missed visits as specified in the schedule of assessments c) Evaluable subjects compliant with the protocol ICH E9: Criteria used for inclusion of data in the per protocol data set include a) Completion of minimal exposure to treatment b) Available measure of the primary variables c) Absence of protocol violations and eligibility criteria d) All of the above d) All of the above ICH E9: In confirmatory trials, it is usual to analyze a) Full analysis set only b) Per protocol Set only c) Full analysis and per protocol sets d) Null hypothesis analysis set c) Full analysis and per protocol sets ICH E9: Missing values in a data set a) Are generally discounted in data analysis b) Are eliminated by extrapolation c) Contribute to bias d) Have no effect on hypothesis testing c) Contribute to bias ICH E9: Covariates in a statistical analysis may include a) Variation in populations between centers in a multi-center trail b) Variations in age subgroups c) Variations by gender d) All of the above d) All of the above ICH E9: Pre analysis review should include considerations of a) Exclusion of subjects from the data set b) Transformation of the variables c) Impact an statistical treatment of outliers d) All of the above d) All of the above ICH E9: Safety and tolerability of the drug are best assessed in a) Phase I trials b) Phase II trials c) Continuously during drug development d) Phase III trials c) Continuously during drug development ICH E9: Blind review occurs a) At various stages of a clinical trial b) After study close out visit for all sites has been completed c) At pre-specified intervals d) Between trial completion and breaking of the blind d) Between trial completion and breaking of the blind ICH E11: Pharmacokinetic studies of a pediatric drug requires a) Studies in adults with the disease b) Studies in pediatric populations with the disease c) Studies in healthy children d) Studies preferably carried out in older children or adolescents b) Studies in pediatric populations with the disease ICH E11: Dosing recommendations for pediatric drugs are based on a) Body area b) Renal clearance c) Liver metabolism d) Mg/kg body weight d) Mg/kg body weight ICH E11: The institutional review board in the United States sets the blood volume that can be obtained from a child a) Based on institutional policy b) Based on guidelines in DHHS regulations c) Based on disease severity d) Based on the age of the child b) Based on guidelines in DHHS regulations ICH E11: The typical restriction on blood draws form children in the United States is set at a) No more than once weekly b) No more than twice weekly c) No more than three time weekly d) No more than four times weekly b) No more than twice weekly ICH E11: The amount of blood volume that may be obtained from a child in the United States is set at a) No more than 50 ml in an eight week period b) No more than a 100 ml in one month c) No more than 20 ml in one week d) Nor more than one unit in four weeks a) No more than 50 ml in an eight week period ICH E11: The amount of blood obtained from a child in a clinical trial may be minimized by the following methods a) Use of sensitive assays and indwelling catheters for sampling and analyzing drugs and metabolites b) Use of laboratories specialized in handling small blood volumes c) Collection of research samples at the same time as clinical care samples d) All of the above d) All of the above ICH E11: Phase IV studies in pediatric populations a) Are not required as there is no regulation that outlines the need b) Are rarely done because safety information is already documented in Phase III trials c) Are recommended only if Phase IV studies in the adult population have not been done d) Are particularly important as the pediatric database is limited at the time of approval d) Are particularly important as the pediatric database is limited at the time of approval What is an Investigational Device Exemption (IDE)? It allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510 (k)s require clinical data to support the application. ICH E11: Age classifications of pediatric subjects in ICH includes a) Preterm newborn infants b) Term newborn infants c) Infants and toddlers d) All of the above d) All of the above ICH E11: 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 c) Varies by state in the United States ICH E11: ICH defines an adolescent as a person who is a) Between 14 and 18 years of age b) Between 12 to 16-18 years of age c) Between 13 and 17 years of age d) Between 16 to 18 years of age b) Between 12 to 16-18 years of age ICH E11: Features pertinent to drug metabolism in a Preterm new born include a) Immaturity of renal and hepatic clearance mechanism b) Drug binding and displacement from proteins c) Penetration into the CNS d) Unique neonatal conditions e) Rapid maturation of physiologic processes that radically influence drug dosing f) Transdermal absorption of drugs g) All of the above g) All of the above ICH E11: In term new born infants features of drug metabolism include a) Stable renal and hepatic clearance compared to preterm newborns b) Oral administration of the drug is predictable and preferred c) Dose adjustments are unlikely to be needed in the course of a clinical trial d) Immaturity of the blood brain barrier may give rise to CNS toxicity d) Immaturity of the blood brain barrier may give rise to CNS toxicity ICH E11: In infants and toddlers features of drug metabolism include a) Hepatic and renal clearance are stable b) Oral absorption is as unreliable as in newborns c) The CNS maturation is nearly complete d) Clearance of drugs on a mg/kg basis may exceed adult values d) Clearance of drugs on a mg/kg basis may exceed adult values In children 2-11 years of age factors to consider in clinical trials include a) Tanner staging for puberty b) Recreational use of drugs, alcohol and tobacco c) a only d) Both a and b d) Both a and b ICH E11: Factors to consider in measuring the effect of a pediatric drug o children between 2 and 11 years of age include all of the following except a) Skeletal muscle growth b) Weight gain c) School attendance and school performance d) Interpersonal interactions with other children d) Interpersonal interactions with other children ICH E11: IRBs reviewing pediatric clinical trials a) Are required to have a pediatrician according to the regulations b) May review the studies without a pediatrician c) Should have a member or experts consulted who are knowledgeable in pediatric ethics and psychosocial issues d) Should have pediatrician who is trained in the disease subspecialty of the clinical trial c) Should have a member or experts consulted who are knowledgeable in pediatric ethics and psychosocial issues ICH E11: Regarding recruitment of in pediatric clinical trials all of the following are true except a) Inappropriate inducements should be avoided b) Reimbursements and subsistence costs may be covered c) The compensation should be divided between the parent and the child d) Any level of compensation no matter how small should be reviewed by the IRB c) Conflicting school and personal schedules d) Noncompliance d) Noncompliance What is ICH E6? Good Clinical Principles This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. -Clinical trials should be conducted in accordance with the Declaration of Helsinki. -A trial should be initiated and continued only if the anticipated benefits justify the risks. -The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail. What is the 1571? the sponsor agreement with the FDA What is the 1572? the investigator agreement with the FDA What is the purpose of source documentation? To verify that trial data in case report forms are consistent with that in the source documents (ICH E6 sec 8.3.13) What is the minimum number of members on an IRB/IEC? 5 ICH E6: In ICH-GCP an audit is defined as a) A systematic and independent examination of trial related activities and documents b) An investigation intended to discover and verify the clinical effects of an investigational product c) Official review of documents facilities records and any other resources d) Overseeing of the progress of a clinical trial a) A systematic and independent examination of trial related activities and documents ICH E6: In ICH-GCP an inspection is defined as a) A systematic and independent examination of trial related activities and documents b) An investigation intended to discover and verify the clinical effects of an investigational product c) Official review of documents, facilities, records and any other resources d) Overseeing of the progress of a clinical trial c) Official review of documents, facilities, records and any other resources ICH E6: In ICH-GCP monitoring is defined as a) A systematic and independent examination of trial related activities and documents b) An investigation intended to discover and verify the clinical effects of an investigational product c) Official review of documents, facilities, records and any other resources d) Overseeing of the progress of a clinical trial d) Overseeing of the progress of a clinical trial ICH E6: In ICH-GCP a clinical trial is defined as a) A systematic and independent examination of trial related activities and documents b) An investigation intended to discover and verify the clinical effects of an investigational product c) Official review of documents, facilities, records and any other resources d) Overseeing of the progress of a clinical trial b) An investigation intended to discover and verify the clinical effects of an investigational product ICH E6: In ICH-GCP an investigator is defined as a) A person responsible for the conduct of the clinical trial b) An individual supervised by the team leader c) A person responsible for initiation, management and financing of a clinical trial d) A person responsible for overseeing the progress of a clinical trial a) A person responsible for the conduct of the clinical trial ICH E6: In ICH-GCP a sponsor is defined as a) A person responsible for the conduct of the clinical trial b) An individual supervised by the team leader c) A person/entity responsible for initiation, management and financing of a clinical trial d) A person/ entity responsible for overseeing the progress of a clinical trial c) A person/entity responsible for initiation, management and financing of a clinical trial ICH E6: In ICH-GCP a monitor is defined as: a) A person responsible for the conduct of the clinical trial b) An individual supervised by the team leader c) A person/entity responsible for initiation, management and financing of a clinical trial d) A person responsible for overseeing the progress of a clinical trial d) A person responsible for overseeing the progress of a clinical trial ICH E6: In ICH-GCP a sub-investigator is defined as a) A person responsible for the conduct of the clinical trial b) An individual supervised by the team leader c) A person/entity responsible for initiation, management and financing of a clinical trial. d) A person responsible for overseeing the progress of a clinical trial b) An individual supervised by the team leader ICH E6: In ICH-GCP a co-investigator is defined as a) A person responsible for overseeing the progress of a clinical trial b) An individual supervised by the team leader c) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader d) A person responsible for funding the clinical trial. c) A person responsible for assuming, when needed, the responsibilities of an investigator/team leader ICH E6: In ICH-GCP quality assurance is defined as a) Planned and systematic action to ensure that the data is generated, recorded and reported according to GCP b) The act of overseeing the progress of a clinical trial c) The act of performing inspections of a clinical trial d) The act of performing an official review of a clinical trial a) Planned and systematic action to ensure that the data is generated, recorded and reported according to GCP ICH E6: ICH-GCP requires that a regulatory authority be given direct access to a clinical trial records. Direct access includes the ability to do all except a) Examine and analyze all clinical trial records b) Verify the clinical trial records c) Reproduce any records as needed d) Not assume responsibility during an audit for the confidentiality of the clinical trial records d) Not assume responsibility during an audit for the confidentiality of the clinical trial records ICH E6: Source documents in a clinical trial refer to all except a) Medical notes and pertinent parts of a medical record b) Laboratory and radiology findings c) Pathology reports d) Patient diaries and pharmacy records e) Site monitoring reports e) Site monitoring reports ICH E6: Which of the following statements is true of auditing and monitoring of a clinical trial? a) Audits often occur prior to clinical trial enrollment as do monitoring visits b) Audits and monitoring visit are both periodic in nature and occur throughout the progress of a clinical trial c) Audits are generally performed by a regulatory authority whereas monitoring is done by a CRO or sponsor d) Both audits and monitoring visits involve necessary assessments at study close out c) Audits are generally performed by a regulatory authority whereas monitoring is done by a CRO or sponsor d) Is similar to DHHS in its requirements ICH E6: According to ICH the IRB should obtain the following documents from the investigator a) Protocol, consent, recruitment procedures, investigator's brochure, payments b) Protocol , consent, case report forms , payments, CV c) Protocol, consent, monitoring plan, payments, CV, recruitment d) Protocol, monitoring plan, investigator's brochure, payments, CV a) Protocol, consent, recruitment procedures, investigator's brochure, payments ICH E6: According to ICH the copy of the CV given to the IRB should be a) No more than a year old b) No more than two years old c) No date on the CV is required d) Current d) Current ICH E6: The statement that continuing review be carried out at least once annually is affirmed by a) ICH only b) DHHS and ICH only c) DHHS only d) DHHS, ICH, and FDA d) DHHS, ICH, and FDA ICH E6: The IRB requirements in ICH differ from DHHS requirements in a) Requiring annual continuing review b) Ability for approval or disapproval c) Ability for termination or suspension d) Requirements for review of non-therapeutic trials d) Requirements for review of non-therapeutic trials ICH E6: Regarding ICH provisions for emergency use of an investigational article which of the following is applicable? a) ICH describes guidelines for emergency use similar to those required by the FDA. b) ICH makes a provision for emergency medical care similar to that provided in DHHS c) ICH describes guidelines for use of an investigational article in an emergency setting d) ICH states that if consent of subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed d) ICH states that if consent of subject or LAR cannot be obtained then relevant ethical concerns and applicable regulatory requirements be addressed ICH E6: With regard to payments to subjects ICH indicates that a) Payments be free of coercion and undue influence b) Payments should be prorated c) Methods, amounts and schedule of payments be set forth in the informed consent. d) All of the above d) All of the above ICH E6: The guidelines for IRB composition in ICH are the same as those in a) DHHS only b) FDA only c) DHHS and FDA d) CIOMS c) DHHS and FDA ICH E6: An important affirmation regarding the ICH guidelines for the IRB which differ from DHHS regulation is that a) The IRB should comply with GCP b) Should have at least five members c) Should have a non-scientific member d) Should have a non-affiliated member a) The IRB should comply with GCP ICH E6: With regard to a quorum for the IRB ICH specifies that a) It is majority of members b) It is more than 50% of the roster c) It is governed by a specified formula d) It should be stipulated in the written procedures d) It should be stipulated in the written procedures ICH E6: With regard to ICH, conflict of interest on the IRB, which of the following is not correct: a) The IRB may invite non-members but only members can vote b) The investigator may not participate in deliberations or the vote c) There is no provision for non-tangible conflict of interest d) Conflict of interest is defined as financial interest greater than $10000 d) Conflict of interest is defined as financial interest greater than $10000 ICH E6: That the investigator may make changes in a protocol without IRB approval to eliminate an immediate hazard is stated in a) DHHS only b) ICH only c) DHHS and ICH d) Not stated exactly in either DHHS or ICH c) DHHS and ICH ICH E6: According to ICH the investigator should promptly report the following to the IRB a) Deviations from protocol to eliminate immediate hazards b) Changes in risk in protocol c) Serious and unexpected adverse drug reactions d) New information that may affect the safety of subjects e) All of the above e) All of the above ICH E6: According to ICH, the sponsor may request the following from the IRB a) A copy of the minutes of an IRB meeting b) IRB correspondence with OHRP c) Rationale for IRB disapproval d) Written procedures and membership lists d) Written procedures and membership lists ICH E6: According to ICH the investigator should a) Demonstrate the potential for recruiting the required number of subjects b) Have sufficient time and staff to conduct the trial c) Ensure that the delegated staff be informed about the protocol, duties and product d) All of the above d) All of the above ICH E6: According to ICH the investigator should a) Ascertain the reason for withdrawal of a subject b) Inform a subject's physician about subject participation in a clinical trial c) Ensure that adequate care is provided for any adverse event experienced by the subject d) All of the above d) All of the above ICH E6: With regard to keeping the IRB informed about the Investigator's brochure ICH states that a) It is the sponsor's responsibility b) It is the investigator's responsibility c) It is not needed d) Updates to the brochure need not be provided b) It is the investigator's responsibility ICH E6: If the investigator implements a change in the protocol to eliminate an immediate hazard the following entities should be informed a) The IRB b) The sponsor c) Regulatory authority if applicable d) All of the above d) All of the above ICH E6: ICH recommends that responsibility for the investigational product and its accountability be assigned to a) The sub-investigator