ACRP-CP EXAM NEWEST ACTUAL EXAM STUDY GUIDE QUESTIONS AND DETAILED CORRECT ANSWERS, Exams of Nursing

Download ACRP-CP EXAM NEWEST ACTUAL EXAM STUDY GUIDE QUESTIONS AND DETAILED CORRECT ANSWERS and more Exams Nursing in PDF only on Docsity! ACRP-CP EXAM NEWEST ACTUAL EXAM STUDY GUIDE QUESTIONS AND DETAILED CORRECT ANSWERS | A+ GRADE 2024-2025 To be a qualifying clinical trial, which three requirements must be met? Correct Answer Therapeutic Intent Enrolls patients with diagnosed disease Evaluates an item/service that falls within a Medicare Benefit Category Define informed consent Correct Answer A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Primary purpose of IRB Correct Answer To ensure the protection of the rights and welfare of the human subjects When can IRB waive informed consent? Correct Answer IRB has the ability to waive the informed consent requirement if the research is no more than minimal risk and involves no procedures for which consent is required outside of the research context and in emergency research An investigational New Drug (IND) Application becomes effective ___ days after receipt by the FDA (barring a hold, request for additional information, or rejection of an application); is valid one year; and must be updated within ___ days of taking effect. Correct Answer 30, 60 What is the purpose of the IRB/IEC? Correct Answer An IRB/IEC should safeguard the rights, safety, and well- being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects. How frequently should the IRB/IEC conduct a CR of each ongoing trial? Correct Answer The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year. What is the minimum number of members for an IRB/IEC? And what specific people need to be involved? Correct Answer (a) At least five members. (b) At least one member whose primary area of interest is in a nonscientific area. (c) At least one member who is independent of the institution/trial site. What four things should the investigator promptly report to the IRB/IEC? Correct Answer (a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects. After the New Drug Application is approved, the responsibility for reporting safety issues to the FDA rests with Correct Answer The sponsor To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? Correct Answer Contract Research Organization Define role of CDRH and abbreviation Correct Answer Center for Devices and Radiological Health FDA center that assures that patients and providers have timely and continued access to safe, effective, and high- quality medical devices and safe radiation-emitting products. Define Adverse Drug reaction Correct Answer all noxious and unintended response to a medicinal product related to any dose. How many days does a sponsor have to report non-fatal IND safety report to the FDA Correct Answer 15 calendar days What are examples of hidden costs in a study budget Correct Answer Unexpected equipment failure Four types of monitoring visits are: Correct Answer Qualification, Initiation, Routine, Close-out Define Protocol Correct Answer A document that describes the objective(s), design, methodology, statistical considerations and organization of a trial. Phase III Correct Answer Phase of trial that primarily focuses on confirming effectiveness and establishing a safety profile in subjects with the disease or condition and other concurrent illnesses and medications. Case Report Forms (CRFs) are typically developed by the ____ and the ____ performs source document verification Correct Answer Sponsor, Monitor Define BIMO and abbreviation Correct Answer Bioresearch Monitoring Program Information FDA center that ensures the protection of research subjects and the integrity of data submitted to the agency in support of a marketing application. Define AE Correct Answer An untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causa relationship with this treatment. Define UADE Correct Answer Unanticipated, adverse device effect. Must be serious, related and unexpected Whom should the sponsor notify of findings that affect the safety of the subjects? Correct Answer All participating investigators and the regulatory authority According to the ICH GCP, who is responsible for ensuring that clinical trial site staff is trained on the protocol, investigation product, and their trial-related duties, and functions Correct Answer The PI What is the primary difference between an AE and an ADR(advanced drug reaction) Correct Answer An ADR is always related to the study drug and an AE may or may not be related to the study drug. Define CDER and abbreviation Correct Answer Center for Drug Evaluation and Research FDA center responsible for regulating over-the-counter and prescription drugs, including generic drugs At what frequency does an RIB need to conduct continuing review of each clinical trial? Correct Answer Intervals appropriate to the degree of risk to human subjects, but at least once per year. The purpose of ____ is to document qualifications and eligibility to conduct a trial and/or provide medical supervision of subjects Correct Answer Curriculum vitae What are the requirements for conducting a study in the USA Correct Answer A study conducted in the USA needs Phase I Correct Answer The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? Correct Answer Principal investigator Define GCP Correct Answer An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 Correct Answer Nazi Medical Experiments Which ICH Guideline is known as the GCP guideline? Correct Answer E6(R2) What are the basic ethical principles of the Belmont Report? Correct Answer Beneficence, Respect for persons, Justice Define CBER, and full title Correct Answer Center for Biologics Evaluation and Research FDA center that regulates blood, vaccine, gene therapy and tissue What is the International Conference on Harmonization (ICH) Guidelines? Correct Answer A unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and United States. What twenty items need to be included in the ICF and its discussion? Correct Answer (a) That the trial involves research. (b) The purpose of the trial. (c) The trial treatment(s) and the probability for random assignment to each treatment. (d) The trial procedures to be followed, including all invasive procedures. (e) The subject's responsibilities. (f) Those aspects of the trial that are experimental. (g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant. (h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this. (i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks. (j) The compensation and/or treatment available to the subject in the event of trial related injury. (k) The anticipated prorated payment, if any, to the subject for participating in the trial. (l) The anticipated expenses, if any, to the subject for participating in the trial. (m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled. (n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access. (o) That records identifying the subject will be kept confidential and, to the extent permi Should each patient receive a copy of the signed and dated written ICF? Correct Answer Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and necessary, outside consultant(s) may be appointed for this purpose. For how long should sponsor specific essential documents be retained? Correct Answer The sponsor specific essential documents should be retained until at least 2- years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2-years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirement(s) or if needed by the sponsor. What are the three purposes of trial monitoring? Correct Answer The purposes of trial monitoring are to verify that: (a) The rights and well-being of human subjects are protected. (b) The reported trial data are accurate, complete, and verifiable from source documents. (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). What is the purpose of an audit? Correct Answer The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements. What are the 15 components of a study protocol? Correct Answer 1. General information 2. Background information 3. Trial objectives and purpose 4. Trial design 5. Selection and Withdrawal of subjects 6. Treatment of subjects 7. Assessment of efficacy 8. Assessment of safety 9. Statistics 10. Direct access to source data/documents 11. Quality control and quality assurance 12. Ethics 13. Data handling and record keeping 14. Financing and insurance 15. Publication policy What are the contents of the IB? Correct Answer Investigator's Brochure consists of: 1. Table of contents 2. Summary 3. Introduction 4. Physical, chemical, and pharmaceutical properties and formulation 5. Nonclinical studies 6. Effects in humans 7. Summary of data and guidance for the investigator What is the overall aim of the IB? Correct Answer The overall aim of this section is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial. This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s). Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product. Can patients and/or patient organizations be consulted during the drug development process? Correct Answer Consulting with patients and/or patient organisations during drug development can help to ensure that patients' perspectives are captured. The views of patients (or of their caregivers/parents) can be valuable throughout all phases of drug development. Involving patients early in the design of a study is likely to increase trust in the study, facilitate recruitment, and promote adherence. Patients also provide their perspective of living with a condition, which may contribute to the determination, for example, of endpoints that are meaningful to patients, selection of the appropriate population and duration of the study, and use of acceptable comparators. This ultimately supports the 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Is a congenital anomaly/birth defect What is an UADR? Correct Answer Unexpected adverse drug reaction (UADR) 1. An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., IB for an unapproved IP or package insert/summary of product characteristics for an approved product) Who constitutes a vulnerable subject? Correct Answer Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. GCP: Clinical trials should be conducted in accordance with the ethical principles that have their origin in the ___________ __ ________, and that are consistent with GCP and the applicable regulatory requirement(s). Correct Answer Declaration of Helsinki GCP: What is beneficence? Correct Answer The idea that foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. GCP: What are the most important considerations in clinical trials? And should thus prevail over interests of science and society? Correct Answer The rights, safety, and well-being of the trial subjects. GCP: What qualifies an individual to conduct, or work on, a clinical trial? Correct Answer Education, training, and experience to perform his or her task(s). GCP: What should be obtained from every subject prior to clinical trial participation? Correct Answer Freely given informed consent.