ACRP CCRC Exam Questions And Answers Latest Updated 2024 (100% Verified)

ACRP CCRC Exam Questions And Answers Latest Updated 2024 (100% Verified) What are expected or possible consequences of over-estimation of recruitment potential? - Answer - 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? - Answer Subject welfare When is the investigator allowed to deviate from the protocol? - Answer 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? - Answer - The Sponsor - IRB/IEC - Regulatory Authorities Which conditions should be fulfilled when enrolling a subject into your trial? - Answer - 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? - Answer - 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? - Answer 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? - Answer 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? - Answer 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? - Answer The principle investigator. A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? - Answer No What statements are true concerning an adverse drug reaction? - Answer - All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR - An ADR suggests a relationship to trail medication - All ADRs must be documented What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - Answer - Any AE that results in death - Any AE that results in inpatient hospitalization - Any AE that is a congenital anomaly During a study visit a patient tells the investigator that she visited an emergency room and received intensive treatment for allergic bronchospasm. Since the patient was in the emergency room for only three hours, the investigator did not assess the event as serious. Is this a correct assessment? - Answer No, this would be a medically important event and should be considered serious What data points minimally need to be reported by the site when reporting an SAE, so that the sponsor can process the event? - Answer Identification of event, product, and trial subject During a visit with investigator, a subject reported feeling heart palpitations for a brief period of time during the previous evening. The heart palpitations resolved without reoccurrence. The investigator considered these symptoms to be unrelated to study drug. The next day, the subject told a fellow student that he felt tired and was planning on taking a nap. Later, the subject was found dead. A preliminary report from the medical examiner indicated the subject died of pulmonary embolism. What should your next course of action be? - Answer - Record these events in case report form - Immediately notify sponsor about serious adverse events When asked by a regulatory body why they received SAE related information on 12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason being they received the trial related SAE information from the investigator in 12/2013. Is the sponsor correct in only holding the investigator accountable for their late reporting? - Answer No, the sponsor should support the conduct QC activities with the sites to help them ensure timely SAE reporting. 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? - Answer 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? - Answer - An adverse event - An adverse drug reaction In regards to AE and ADR reporting, what statements are true? - Answer - 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 What determines the causality of an adverse event? - Answer The investigator Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? - Answer Quality improvement Which term best describes an independent assessment of completed work to ensure it will meet applicable quality standards? - Answer Quality assurance Which term best describes the activities done to ensure quality output? - Answer Quality control Which term requires structure and a definition of acceptable standards of performance? - Answer Quality planning Which is represented in ALCOA-C? - Answer Attributable What does CAPA stand for? - Answer Corrective and Preventive Action When not completed correctly, which is a major contributing factor to an ineffective CAPA plan? - Answer Root cause analysis What are the cyclical activities performed a part of quality improvement? - Answer Plan, Do, Check, Act What is sued to determine root causes? - Answer - Fishbone diagram - Process flow charts - The 5 Whys What are fishbone diagrams, process flow charts, and the 5 whys used for determining? - Answer Root causes What is the key difference between quality improvement and quality assurance activities? - Answer Can be performed by persons involved in doing the work. What are the elements of quality management system? - Answer - Quality planning - Quality assurance - Quality control What is part of a quality management plan? - Answer - Quality policy statement - Quality goals - Organizational structure with defined roles What documents support quality control? - Answer - SOPS, - Concomitant medication log Quality standards are set by? - Answer - Regulatory bodies - IRB/IECs What are the basic steps of risk management? - Answer - Analyze risk - Identify risk - Control risk Adhering to the principles represented in ALCOA-C support? - Answer Good documentation practice. What are the correct order of steps CAPA performs? - Answer - Identify issue - Determine root cause - Implement plan for correction - Assess effectiveness of correction Having which two people sign and date the consent form is a quality standard for the informed consent documentation? - Answer The subject and the person obtaining consent. True or False. Moving away from preventing problems to identifying and correcting problems is a key paradigm shift taking place in clinical trial conduct. - Answer False True or False. When engaged in quality improvement activities, it's important to identify who is to blame for quality failure? - Answer False What skills are essential for making risk based decision making successful? - Answer - Quality control skills - Motivational skills - Change management skills What are steps in risk assessment? - Answer - 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? - Answer Insufficient IP accountability. When practicing RBDM in clinical research, what should be the primary focus? - Answer Subject safety and quality of the data. When assessing the seriousness of a risk, what are the primary considerations that need to be taken into account? - Answer - The likelihood of occurrence - The consequences of the occurrence When assessing the seriousness of a risk, what should the risk be compared to? - Answer Standard clinical practice. What is essential to keep in mind when determining actions to mitigate potential risks? - Answer The make a risk-based decision following a risk management plan. Where should potential risks be documented? - Answer A risk management plan. What skills are most affected by the introduction of risk-based decision making? - Answer - Motivational skills - Change management Whats the most important thing to keep in mind when introducing risk-based decision making into clinical research? - Answer 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? - Answer At all stages of the trial. When should a risk management plan be updated? - Answer Continuously Whats the first step in the RBDM process? - Answer Determining an end goal. What are the objectives of RBDM in clinical trials? - Answer - 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 ACRP CCRC Exam Prep Questions(Module Quiz Questions)And Answers 2023 What are two true statements about RBDM? - Answer - 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? - Answer - Risk avoidance - Risk mitigation What are two possible risk mitigation strategies? - Answer - Training staff - Implementing SOPs What are the sites responsibilities regarding QC? - Answer - Sites need to ensure high quality of data - Sites need to conduct their own QC In the RBDM process, what's the next step after determining the end goal? - Answer Risk assessment. True or False? A CRC claims that you doin't need to assess the impact of your risk management efforts on an ongoing basis as long as the plan was executed properly. - Answer False How is the seriousness of a risk calculated? - Answer Likelihood of risk x consequences of risk. True or False? RBDM only applies to RBM strategies. - Answer False What are three activities that should be considered by sites in a risk-based monitoring environment? - Answer - Implementing additional quality control measures - Revising study contracts - Updating internal SOPs Differences ithat may be seen in a RBM study include? - Answer Monitors may conduct less frequent on-site visits. True or False? RBM will have no impact on site. - Answer False True or False? An example of a risk indicator would be an out of range laboratory value related to IC/EC on a subject that was just randomized. - Answer True True or False? RBM embraces quality improvement processes? - Answer True True or False? A key component of RBM is building quality into protocol design in order to enable more focused and efficient monitoring. - Answer True ACRP CCRC Exam Prep Questions(Module Quiz Questions)And Answers 2023 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. - Answer True The clinical trials transformation initiative (CTTI) recommends focus on what? - Answer Quality by design. True or False? RBM focuses on study-specific parameter to determine an appropriate blend of monitoring activities. - Answer True True or False? RBM is a FDA based concept that doesn't have any accountability to international studies. - Answer False What are three key areas of focus in RBM? - Answer - Patient safety - Accurate representation of key data - Protocol compliance True or False? RBM deploys available monitoring resources without regard for a trials specific identified risks. - Answer False