Download ACRP CCRC EXAM PREP 2025/2026 | BRAND NEW ACTUAL EXAM WITH 100% VERIFIED QS AND AS and more Exams Clinical Medicine in PDF only on Docsity!
ACRP CCRC EXAM PREP 2025/2026 |
BRAND NEW ACTUAL EXAM WITH 100%
VERIFIED QUESTIONS AND CORRECT
ANSWERS
True or False? Researchers have found that trials failing to reach 60% minimum projected accrual goal within expected period will always reach enrollment goals by time of enrollment closure. - correct answer - False What are elements of a formal feasibility assessment process? - correct answer - - Interest
- Accruability
- Capacity
- Menu diversification True or False? One of four participants leave a trial before it's completed. - correct answer - True
True or False? Only ~50% of participant who signed consent could explain how they're randomized during the trial. - correct answer - True True or False? Clinical research sites may recruit subjects for trials by contacting their own patients, asking outside physicians to refer their patients, or by advertising trial within community. - correct answer - True True or False? It's important for a clinical research site to have a clinical trial menu reflective of patient population. A formal feasibility assessment of all potential trials often satisfies this need. Assessment includes examining interest, capacity, potential rate of accrual and diversification - correct answer - True True or False? Sponsors expect sites to be prepared with estimate of number of subjects they believe they can enroll within specific time frames, including justification for the amount. This estimate is used by sponsors to determine which sites to invite to participate in their trials. - correct answer - True True or False? A well-educated person is always health literate. - correct answer - False
Which groups have the lowest participation rates? - correct answer - - People above 65 years old
- People from rural areas
- People from racial/ethnic minority groups Sponsors consider what criteria when selecting clinical research sites for their trials - correct answer - - Coordinator workload (number of studies per coordinator)
- IRB/IEC timelines and reporting policies
- Number/type of competing trials ongoing at site
- Investigator expertise in area being researched Which elements of patient centered care as described? - correct answer - - Learning style
- Health literacy
- Emotions Which are characteristics of health literacy? - correct answer - - Capacity to process and understand basic healthcare information
- Rely on cultural/conceptual knowledge What's the take home point? Patient approach and offer: A clinical site makes a decision that each patient who's potentially eligible for trial be offered a chance to participant. - correct answer - Reducing opportunities for subjective assessment. What's the take home point? Optimal communication and education: All participants will have their information, knowledge, and behavior-related needs met. - correct answer - Fostering dialogue and assessing comprehension. The average population in the US of person with EP is estimated to be? - correct answer - ~9% In summary, the 7 operational principles are? - correct answer - The legs on which all of our efforts to improve accrual are based. What are expected or possible consequences of over-estimation of recruitment potential? - correct answer - - The trial will overrun its projected timeline
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? - correct 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? - correct 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? - correct 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? - correct 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? - correct answer - The principle investigator. A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? - correct answer - No What statements are true concerning an adverse drug reaction? - correct 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
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? - correct 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? - correct 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? - correct 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? - correct answer - - An adverse event
- An adverse drug reaction In regards to AE and ADR reporting, what statements are true? - correct 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? - correct answer - The investigator Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? - correct answer - Quality improvement
What are the cyclical activities performed a part of quality improvement? - correct answer - Plan, Do, Check, Act What is sued to determine root causes? - correct answer - - Fishbone diagram
- Process flow charts
- The 5 Whys What are fishbone diagrams, process flow charts, and the 5 whys used for determining? - correct answer - Root causes What is the key difference between quality improvement and quality assurance activities? - correct answer - Can be performed by persons involved in doing the work. What are the elements of quality management system? - correct answer - - Quality planning
- Quality assurance
- Quality control
What is part of a quality management plan? - correct answer - - Quality policy statement
- Quality goals
- Organizational structure with defined roles What documents support quality control? - correct answer - - SOPS,
- Concomitant medication log Quality standards are set by? - correct answer - - Regulatory bodies
- IRB/IECs What are the basic steps of risk management? - correct answer -
- Analyze risk
- Identify risk
- Control risk Adhering to the principles represented in ALCOA-C support? - correct answer - Good documentation practice.
What skills are essential for making risk based decision making successful? - correct answer - - Quality control skills
- Motivational skills
- Change management skills What are steps in risk assessment? - correct 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? - correct answer - Insufficient IP accountability. When practicing RBDM in clinical research, what should be the primary focus? - correct 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? - correct answer - - The likelihood of occurrence
- The consequences of the occurrence When assessing the seriousness of a risk, what should the risk be compared to? - correct answer - Standard clinical practice. What is essential to keep in mind when determining actions to mitigate potential risks? - correct answer - The make a risk-based decision following a risk management plan. Where should potential risks be documented? - correct answer - A risk management plan. What skills are most affected by the introduction of risk-based decision making? - correct answer - - Motivational skills
- Change management Whats the most important thing to keep in mind when introducing risk-based decision making into clinical research? - correct answer - The focus of clinical research is on patient safety and quality data.
Planning for how to handle risks include what two activities? - correct answer - - Risk avoidance
- Risk mitigation What are two possible risk mitigation strategies? - correct answer
- Implementing SOPs What are the sites responsibilities regarding QC? - correct 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? - correct 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. - correct answer - False
How is the seriousness of a risk calculated? - correct answer - Likelihood of risk x consequences of risk. True or False? RBDM only applies to RBM strategies. - correct answer - False What are three activities that should be considered by sites in a risk-based monitoring environment? - correct answer - - Implementing additional quality control measures
- Revising study contracts
- Updating internal SOPs Differences ithat may be seen in a RBM study include? - correct answer - Monitors may conduct less frequent on-site visits. True or False? RBM will have no impact on site. - correct answer
- False
