Download ACRP CCRC FINAL EXAM 2025||250+ QUESTIONS AND ANSWERS|NEW UPDATE|GRADED A+ and more Exams Nursing in PDF only on Docsity!
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ACRP CCRC FINAL EXAM 2025||250+ QUESTIONS
AND ANSWERS|NEW UPDATE|GRADED A+
What are expected or possible consequences of over−estimation of recruitment potential? – ANS:->>> The trial will overrun its projected timeline − The recruitment period will be prolonged and more sites may be needed − The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? − ANS:->>> Subject welfare When is the investigator allowed to deviate from the protocol? − ANS:->>> When there is an immediate hazard to a patient. If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? − ANS:->>> The Sponsor − IRB/IEC − Regulatory Authorities Which conditions should be fulfilled when enrolling a subject into your trial? − ANS:->>> Subject meets all inclusion criteria − Subject has given written informed consent You've been delegated to handle the storage and inventory of IP. The study drug must be stored below 25C/77F. On a summer Monday morning you discover that the temperature recording machine in the storage room has failed so you doin't
know what the temperature has been over the weekend. You check the current temperature; it's 24C/75F. What should you do? − ANS:->>> Contact the Sponsor, explain what happened and ask for instructions − Set up a site staff meeting to conduct a root cause analysis A protocol amendment was issued for a trial. Your site received IRB approval for the amendment and wants to implement the increase in PO dose for your trial subjects as identified in the amendment trial subjects. As delegated consenting duties you must re−consent trial subjects before being able to administer the adjusted dose. You decide to only re−consent trial subjects who are still taking the IP and not from the subjects woh already completed their drug intake period. Is this allowed according the E6 Guideline for GCP? − ANS:->>> No, these subjects are still enrolled in the trial and therefore need to be updated on any changes to the protocol. A trial subject informs you she no longer wants to participant in the trial. What should your course of action be? − ANS:->>> You ask if the patient wishes to share the reason why she wants to leave the trial. If not, you exclude the subject from the trial immediately. A patient cannot recall the name of the heart condition medication he took a few years ago. This is important information for deciding whether the patient may be enrolled in a clinical trial (IC/EC). What's your best course of action? − ANS:-
You attempt to retrieve the patients medical history by contacting previous caregivers and you wait for additional information before enrollment. Who has ultimate trial responsibility for each subject? − ANS:->>> The principle investigator. A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? − ANS:->>> No What statements are true concerning an adverse drug reaction? − ANS:->>> All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR
A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator considers this event possibly related to the study drug even though this is not listed in the IB as a potential adverse reaction. What would the investigator report this event to the sponsor as? − ANS:->>> An unexpected, serious adverse event A 22y/o male was entered into a clinical study for treatment of schizophrenia The study drug was administered orally, BID. One week later, the subject visited the investigator complaining of sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug. How should this severe throat be classified? − ANS:->>> An adverse event − An adverse drug reaction In regards to AE and ADR reporting, what statements are true? − ANS:->>> All ADRs are AEs but not all AEs are ADRs − Worsening in pre−existing medical conditions is an AE −Preplanned hospitalization is usually not an SAE Who determines the causality of an adverse event? − ANS:->>> The investigator Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? − ANS:->>> Quality improvement Which term best describes the activities done to ensure quality output? − ANS:-
Quality control Which term requires structure and a definition of acceptable standards of performance? − ANS:->>> Quality planning ensure it will meet applicable quality standards? − ANSWER Quality assurance Which term best describes an independent assessment of completed work to
What is ALCOA−C? − ANS:->>> It's an insightful checklist which is part of the official 21 Code of Federal Regulations (CFR); has been implemented in medical practices to ensure confidentiality, credibility, accuracy, and validation. Attributable Legible Contemporaneous Original Accurate Complete What does CAPA stand for? − ANS:->>> Corrective and Preventive Action When not completed correctly, which is a major contributing factor to an ineffective CAPA plan? − ANS:->>> Root cause analysis What are the cyclical activities performed as part of quality improvement? − ANS:->>> Plan, Do, Check, Act What is used to determine root causes? − ANS:->>> Fishbone diagram − Process flow charts − The 5 Whys What are fishbone diagrams, process flow charts, and the 5 whys used for determining? − ANS:->>> Root causes What are the elements of quality management system? − ANS:->>> Quality activities? − ANSWER Can be performed by persons involved in doing the work. What is the key difference between quality improvement and quality assurance
True or False. Moving away from preventing problems to identifying and correcting problems is a key paradigm shift taking place in clinical trial conduct. − ANS:->>> False True or False. When engaged in quality improvement activities, it's important to identify who is to blame for quality failure? − ANS:->>> False What skills are essential for making risk based decision making successful? − ANS:-
Quality control skills − Motivational skills − Change management skills What are steps in risk assessment? − ANS:->>> Identifying the consequences of risks occurring − Categorizing risks − Identifying risks What risk should be appointed highest priority to manage in view of patient safety and data quality? − ANS:->>> Insufficient IP accountability. When practicing RBDM in clinical research, what should be the primary focus? − ANS:->>> Subject safety and quality of the data. − The consequences of the occurrence When assessing the seriousness of a risk, what should the risk be compared to? − ANS:->>> Standard clinical practice. What is essential to keep in mind when determining actions to mitigate potential risks? − ANS:->>> The make a risk−based decision following a risk management plan. that need to be taken into account? − ANSWER − The likelihood of occurrence When assessing the seriousness of a risk, what are the primary considerations
Where should potential risks be documented? − ANS:->>> A risk management plan. What skills are most affected by the introduction of risk−based decision making? − ANS:->>> Motivational skills − Change management Whats the most important thing to keep in mind when introducing risk−based decision making into clinical research? − ANS:->>> The focus of clinical research is on patient safety and quality data. At what time period during the trial is a risk management plan benefical? − ANS:-
At all stages of the trial. When should a risk management plan be updated? − ANS:->>> Continuously Whats the first step in the RBDM process? − ANS:->>> Determining an end goal. What are the objectives of RBDM in clinical trials? − ANS:->>> Targeting quality control activities to the most vital pints to ensure quality data
Subject safety and quality of the data. − The consequences of the occurrence When assessing the seriousness of a risk, what should the risk be compared to? − ANS:->>> Standard clinical practice. What is essential to keep in mind when determining actions to mitigate potential risks? − ANS:->>> The make a risk−based decision following a risk management plan. that need to be taken into account? − ANSWER − The likelihood of occurrence When assessing the seriousness of a risk, what are the primary considerations Where should potential risks be documented? − ANS:->>> A risk management plan. What skills are most affected by the introduction of risk−based decision making? − ANS:->>> Motivational skills − Change management Whats the most important thing to keep in mind when introducing risk−based decision making into clinical research? − ANS:->>> The focus of clinical research is on patient safety and quality data. At what time period during the trial is a risk management plan benefical? − ANS:- >>> At all stages of the trial. When should a risk management plan be updated? − ANS:->>> Continuously Whats the first step in the RBDM process? − ANS:->>> Determining an end goal. What are the objectives of RBDM in clinical trials? − ANS:->>> Targeting quality control activities to the most vital pints to ensure quality data − Applying risk avoidance and risk mitigation strategies to avoid endangering subject safety What are two true statements about RBDM? − ANS:->>> Risk−based decision making is a process, not a one−time activity − RBDM is a continuous process in which the endpoint leads back to earlier stages Planning for how to handle risks include what two activities? − ANS:->>> Risk avoidance − Risk mitigation
True or False? RBM embraces quality improvement processes? − ANS:->>> True True or False? A key component of RBM is building quality into protocol design in order to enable more focused and efficient monitoring. − ANS:->>> True True or False? Risk−based SDV makes more efficient use of monitoring resources by focusing on data that impacts patient safety and the integrity of the clinical trial data. − ANS:->>> True The clinical trials transformation initiative (CTTI) recommends focus on what? − ANS:->>> Quality by design. True or False? RBM focuses on study−specific parameter to determine an appropriate blend of monitoring activities. − ANS:->>> True True or False? RBM is a FDA based concept that doesn't have any accountability to international studies. − ANS:->>> False What are three key areas of focus in RBM? − ANS:->>> Patient safety − Accurate representation of key data − Protocol compliance True or False? RBM deploys available monitoring resources without regard for atrials specific identified risks. − ANS:->>> False What should be considered part of a proactive approach for a sponsor? − ANS:-
− Identification of risk and strategies for mitigation − Feasibility process to identify qualified sites − Training a management plan to ensure sites are equipped to work on study
What should be considered part of a proactive approach for a site? − ANS:->>> Ensure that the study population matches the site population − Verification that adequate resources are available to conduct the trial − Ensure protocol requirements are consistent with standard of care What are three key elements included as part of SOP development? − ANS:->>> Develop a template − Designate categories − Determine a number system Whats an example of quality assurance at a site? − ANS:->>> Independent audits What's the purpose and preferred order of training? − ANS:->>> Understanding, ownership, and application.− What three assumptions are included in the six knowles principles for adult learners? − ANS:->>> Practical − Relevancy oriented − Goal oriented True or False? A retroactive approach is the best approach to ensure subject safety. − ANS:->>> False What's the primary purpose of SOPs? − ANS:->>> To ensure consistency through standardization − To prevent individuals from conducting procedures differently than their colleagues As a foundation for quality control the individuals that implement and follow the systems much have which of the following characteristics? − ANS:->>> Solid understanding of the processes in place
What is a true statement regarding FDA guidance for industry investigator responsibilities? − ANS:->>> FDAs guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are sited. What are expectations in relation to the qualifications of an investigator? − ANS:-
Be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. − Be thoroughly familiar with appropriate use of IP − Permit for monitoring and auditing by the sponsor and inspection by the appropriate regulatory authorities True or False? If the investigator is a non−physician, the investor should make Practical − Relevancy oriented − Goal oriented True or False? A retroactive approach is the best approach to ensure subject safety. − ANS:->>> False What's the primary purpose of SOPs? − ANS:->>> To ensure consistency through standardization − To prevent individuals from conducting procedures differently than their colleagues As a foundation for quality control the individuals that implement and follow the systems much have which of the following characteristics? − ANS:->>> Solid understanding of the processes in place What is a true statement regarding FDA guidance for industry investigator responsibilities? − ANS:->>> FDAs guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are sited. What are expectations in relation to the qualifications of an investigator? − ANS:- >>> Be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. − Be thoroughly familiar with appropriate use of IP − Permit for monitoring and auditing by the sponsor and inspection by the appropriate regulatory authorities True or False? If the investigator is a non−physician, the investor should make adequate provision for an necessary medical care. − ANS:->>> True What are three true statements with respect to protecting the rights, safety, and welfare of study subjects? − ANS:->>> Providing subjects with method of communication with the investigator or qualified designee for questions or concerns − Adhering to the protocol so that study subjects aren't exposed to unreasonable risk − Providing reasonable access to needed medical care is the most important element of investigator responsibility. − ANS:->>> True True or False? Within the US, clinical investigations of drugs and biological What areas are applicable to assess the adequacy of supervision by an investigator? − ANS:->>> Whether individuals who were delegated tasks were qualified to reform such tasks True or False? Protecting the rights, safety, and well−being of clinical trial subjects products must be conducted in accordance with 21 CFR part 312. − ANSWER True
− Whether study staff received adequate training on how to conduct the delegated tasks − Whether there was adequate supervision and involvement in the ongoing conduct of the study Which entities should be listed on form 1572? − ANS:->>> PI − Facility where research is being conducted − IRB When should 1572 be modified? − ANS:->>> Staff change − Lab change What documentation must accompany the 1572 submission? − ANS:->>> PI CV The 1572 is an agreement between the PO and who? − ANS:->>> FDA To whom is 1572 submitted? − ANS:->>> Sponsor/CRO At what point during a clinical trial is a 1572 created and signed? − ANS:->>> Study start−up Who must sign 1572? − ANS:->>> PI How soon before the FDA, OMB expiration date, must the form 1572 be revised and submitted? − ANS:->>> This date doesn't apply to the resubmission of form and should be ignored. If there are co−investigators working on a clinical trial, where should they be listed on 1572? − ANS:->>> Submit separate 1572 for each investigator. Who's the least likely to be included in section 6 on 1572? − ANS:->>> On−site
− Experience with use in children so far should be collected and used in the development plan − Conduct pharmacodynamic/pharmacokinetic studies in children if theres no relevant information available from similar compounds What should be contained in study design? − ANS:->>> Appropriate comparators − Adequate numbers of subjects − Clear endpoints You're a CRA looking for a site to conduct a phase II trial. What should you be looking for to ensure the site is able to conduct the trial successfully? − ANS:->>> Sufficient resources to ensure patient safety − Sufficient resources (staff, materials, financial) to conduct the required interventions as per protocol − Ability to collect data on therapeutic efficacy, dosage, and other trial−specific goals A site struggles with the conduct of a phase III trial due to lack of site staff to be able to conduct all visits and collect required data as identified in the protocol. Upon completion, the investigator tells the CRA and site staff during a follow−up meeting that she no longer wants to conduct trials because of the resource challenges they faced. What would you recommend the investigator do? − ANS:-
Evaluate available resources (staff, time, patient population, financial) and conduct trials in phase for which the site has resources. What's the difference between phase III and IV trial? − ANS:->>> Phase IV usually requires more subjects and data collection than Phase III − Phase III usually has fewer subjects and follow−up visits than Phase IV WhWhich type of trial will most likely be used in a Phase I? − ANS:->>> Dose− response trial
Appropriate comparators − Adequate numbers of subjects − Clear endpoints You're a CRA looking for a site to conduct a phase II trial. What should you be looking for to ensure the site is able to conduct the trial successfully? − ANS:->>> Sufficient resources to ensure patient safety − Sufficient resources (staff, materials, financial) to conduct the required interventions as per protocol − Ability to collect data on therapeutic efficacy, dosage, and other trial−specific goals A site struggles with the conduct of a phase III trial due to lack of site staff to be able to conduct all visits and collect required data as identified in the protocol. Upon completion, the investigator tells the CRA and site staff during a follow−up meeting that she no longer wants to conduct trials because of the resource challenges they faced. What would you recommend the investigator do? − ANS:- >>> Evaluate available resources (staff, time, patient population, financial) and conduct trials in phase for which the site has resources. What's the difference between phase III and IV trial? − ANS:->>> Phase IV usually requires more subjects and data collection than Phase III − Phase III usually has fewer subjects and follow−up visits than Phase IV WhWhich type of trial will most likely be used in a Phase I? − ANS:->>> Dose− response trial issues as he's already conducted ten Phase III and IV trials. − ANSWER False True or False? An investigator claims he can conduct the Phase II trial without
What is true about confirmation vs exploratory trials? − ANS:->>> Confirmatory trials are intended to provide firm evidence in support claims. What value type has components that may sometimes be analyzed separately? − ANS:->>> Composite What variable type is usually a scale of ordered categorial ratings? − ANS:->>> Global assessment What variable type may not be a true predictor of the clinical outcome of interest? − ANS:->>> Surrogate What design is most commonly used for confirmatory trials? − ANS:->>> Parallel group What are three true statements about cross−over trials? − ANS:->>> The subjects are their won control − The drug being studied is highly variable − Some subjects start on treatment arm A and other on treatment arm B or C What are the main reasons for having multicenter trials? − ANS:->>> Timeframe for recruitment − Possibility of generalization of results True or False? Concluding that theres a difference between two treatments when in actual fact there is no different is type 1 error. − ANS:->>> True data, assumptions, analytic approaches and data analysis. − ANSWER Robustness Concept that refers to sensitivity of overall conclusions to various limitations of
− Trialing accural rates − Sample size adjustments According to ICH E9, IDMCs should provide what? − ANS:->>> Intervals assess the safety of clinical trial − Recommend to sponsor whether to continue, modify, or stop trial Which are for full−analysis sample set? − ANS:->>> Includes all randomized subjects − Complete follow−up of all randomized subjects for study outcomes if necessary − Most likely to mirror normal day to day practice Which are for a per−protocol sample set? − ANS:->>> Completion of pre−specified minimal exposure to treatment is necessary − Availability of measurements of primary variable is necessary − No major protocol violations nor violation of entry criteria Investigator continues to randomize patient until patient is grouped with investigators desired product. Is this ethical? − ANS:->>> No Data manager suspects fraud and immediately calls investigator stating fraud was committed. Was this the best course of action? − ANS:->>> No Who can detect fraud/misconduct? − ANS:->>> Site staff, trial subject, auditors/inspectors, CRA, data entry personnel or data manager, whistle blower, writer of final trial report Investigator continues postponing dates for QC. Is this unethical behavior? − ANS:-
Yes (Declaration of Helsinki) − ANSWER May consider an unproved intervention What must or may the physician do with regard to unproven intervention?
When selecting trial site, which does the selector need to be vigilant about regarding ethics? − ANS:->>> Investigator and site staff have potential subjects and resources to conduct trial according to protocol What are three key principles of the Belmont Report? − ANS:->>> Respect for persons − Justice − Beneficence True or False? Nuremberg Code states human subjects should be at liberty towithdraw. − ANS:->>> True True or False? A site has limited resources and the investigator is promised a trip if enrollment increases. The CRA claims this is ethical. − ANS:->>> False True or False? There's no need to review/cross−check because unethical conduct almost never occurs anymore. − ANS:->>> False Inspection objective include verifying? − ANS:->>> Rights, safety, welfare of subjects − Compliance with regulations − Adherence to pharmacovigilance requirements − Data integrity of submitted data and reports A report prepared by marketing−authorization holder describing the worldwide safety experience with medicine at defined time after authorization is called? − ANS:->>> Periodic Safety Update Report (PSUR) Potential reasons for an unannounced clinical investigator inspection can include what? − ANS:->>> Receipt of complaint
