{"id":115368,"date":"2023-08-24T10:39:35","date_gmt":"2023-08-24T10:39:35","guid":{"rendered":"https:\/\/learnexams.com\/blog\/?p=115368"},"modified":"2023-08-24T10:39:38","modified_gmt":"2023-08-24T10:39:38","slug":"acrp-practice-exam-2023-questions-and-answers-acrp-practice-exam-2023-questions-and-answers","status":"publish","type":"post","link":"https:\/\/www.learnexams.com\/blog\/2023\/08\/24\/acrp-practice-exam-2023-questions-and-answers-acrp-practice-exam-2023-questions-and-answers\/","title":{"rendered":"ACRP PRACTICE EXAM 2023 QUESTIONS AND ANSWERS\/ ACRP PRACTICE EXAM 2023 QUESTIONS AND ANSWERS"},"content":{"rendered":"\n<p>ACRP PRACTICE EXAM 2023 QUESTIONS<br>AND ANSWERS<br>What are expected or possible consequences of over-estimation of recruitment<br>potential? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; &#8211; The trial will overrun its projected<br>timeline<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The recruitment period will be prolonged and more sites may be needed<\/li>\n\n\n\n<li>The study will not have sufficient data within the required timeframe and will be<br>stopped because of lack of budget<br>What should be the first consideration when conducting a clinical trial? &#8212;&#8212;&#8211;<br>CORRECT ANSWER &#8212;&#8212;&#8212; Subject welfare<br>When is the investigator allowed to deviate from the protocol? &#8212;&#8212;&#8211; CORRECT<br>ANSWER &#8212;&#8212;&#8212; When there is an immediate hazard to a patient.<br>If the investigator wanted to deviate from the protocol for a n immediate hazard to a<br>patient, according to ICH E6 guidelines who world they need to report the deviation and<br>rationale to, if appropriate? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; &#8211; The Sponsor<\/li>\n\n\n\n<li>IRB\/IEC<\/li>\n\n\n\n<li>Regulatory Authorities<br>Which conditions should be fulfilled when enrolling a subject into your trial? &#8212;&#8212;&#8211;<br>CORRECT ANSWER &#8212;&#8212;&#8212; &#8211; Subject meets all inclusion criteria<\/li>\n\n\n\n<li>Subject has given written informed consent<br>You&#8217;ve been delegated to handle the storage and inventory of IP. The study drug must<br>be stored below 25C\/77F. On a summer Monday morning you discover that the<br>temperature recording machine in the storage room has failed so you doin&#8217;t know what<br>the temperature has been over the weekend. You check the current temperature; it&#8217;s<br>24C\/75F. What should you do? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; &#8211; Contact the<br>Sponsor, explain what happened and ask for instructions<\/li>\n\n\n\n<li>Set up a site staff meeting to conduct a root cause analysis<br>A protocol amendment was issued for a trial. Your site received IRB approval for the<br>amendment and wants to implement the increase in PO dose for your trial subjects as<br>identified in the amendment trial subjects. As delegated consenting duties you must reconsent trial subjects before being able to administer the adjusted dose. You decide to<br>only re-consent trial subjects who are still taking the IP and not from the subjects woh<br>already completed their drug intake period. Is this allowed according the E6 Guideline<br>for GCP? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; No, these subjects are still enrolled in the<br>trial and therefore need to be updated on any changes to the protocol.<\/li>\n<\/ul>\n\n\n\n<p>A trial subject informs you she no longer wants to participant in the trial. What should<br>your course of action be? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; You ask if the patient<br>wishes to share the reason why she wants to leave the trial. If not, you exclude the<br>subject from the trial immediately.<br>A patient cannot recall the name of the heart condition medication he took a few years<br>ago. This is important information for deciding whether the patient may be enrolled in a<br>clinical trial (IC\/EC). What&#8217;s your best course of action? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;-<br>&#8212;&#8211; You attempt to retrieve the patients medical history by contacting previous<br>caregivers and you wait for additional information before enrollment.<br>Who has ultimate trial responsibility for each subject? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;<br>&#8212; The principle investigator.<br>A trial subject suffers from severe repeat headaches. Should this adverse event be<br>reported to the IRB? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; No<br>What statements are true concerning an adverse drug reaction? &#8212;&#8212;&#8211; CORRECT<br>ANSWER &#8212;&#8212;&#8212; &#8211; All noxious and unintended responses to a medicinal product related<br>to any dose should be considered as an ADR<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>An ADR suggests a relationship to trail medication<\/li>\n\n\n\n<li>All ADRs must be documented<br>What Adverse Events (AEs) are Serious Adverse Events (SAEs)? &#8212;&#8212;&#8211; CORRECT<br>ANSWER &#8212;&#8212;&#8212; &#8211; Any AE that results in death<\/li>\n\n\n\n<li>Any AE that results in inpatient hospitalization<\/li>\n\n\n\n<li>Any AE that is a congenital anomaly<br>During a study visit a patient tells the investigator that she visited an emergency room<br>and received intensive treatment for allergic bronchospasm. Since the patient was in the<br>emergency room for only three hours, the investigator did not assess the event as<br>serious. Is this a correct assessment? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; No, this<br>would be a medically important event and should be considered serious<br>What data points minimally need to be reported by the site when reporting an SAE, so<br>that the sponsor can process the event? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212;<br>Identification of event, product, and trial subject<br>During a visit with investigator, a subject reported feeling heart palpitations for a brief<br>period of time during the previous evening. The heart palpitations resolved without<br>reoccurrence. The investigator considered these symptoms to be unrelated to study<br>drug. The next day, the subject told a fellow student that he felt tired and was planning<br>on taking a nap. Later, the subject was found dead. A preliminary report from the<br>medical examiner indicated the subject died of pulmonary embolism. What should your<br>next course of action be? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; &#8211; Record these events in<br>case report form<\/li>\n\n\n\n<li>Immediately notify sponsor about serious adverse events<br>When asked by a regulatory body why they received SAE related information on<br>12\/2013 from an incident that occurred in 5\/2013, the sponsor explained the reason<br>being they received the trial related SAE information from the investigator in 12\/2013. Is<br>the sponsor correct in only holding the investigator accountable for their late reporting? &#8211;<br>&#8212;&#8212;- CORRECT ANSWER &#8212;&#8212;&#8212; No, the sponsor should support the conduct QC<br>activities with the sites to help them ensure timely SAE reporting.<br>A trial subject in a cardiology trial is admitted to hospital with heart attack. The<br>investigator considers this event possibly related to the study drug even though this is<br>not listed in the IB as a potential adverse reaction. What would the investigator report<br>this event to the sponsor as? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; An unexpected,<br>serious adverse event<br>A 22y\/o male was entered into a clinical study for treatment of schizophrenia The study<br>drug was administered orally, BID. One week later, the subject visited the investigator<br>complaining of sever sore throat. The IB lists this as an occurrence reported by 1% of<br>subjects receiving drug. How should this severe throat be classified? &#8212;&#8212;&#8211; CORRECT<br>ANSWER &#8212;&#8212;&#8212; &#8211; An adverse event<\/li>\n\n\n\n<li>An adverse drug reaction<br>In regards to AE and ADR reporting, what statements are true? &#8212;&#8212;&#8211; CORRECT<br>ANSWER &#8212;&#8212;&#8212; &#8211; All ADRs are AEs but not all AEs are ADRs<\/li>\n\n\n\n<li>Worsening in pre-existing medical conditions is an AE<br>-Preplanned hospitalization is usually not an SAE<br>What determines the causality of an adverse event? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8211;<\/li>\n\n\n\n<li>The investigator<br>Which term best describes the cyclical process that involves the Plan, Do, Check, Act<br>activities? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; Quality improvement<br>Which term best describes an independent assessment of completed work to ensure it<br>will meet applicable quality standards? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; Quality<br>assurance<br>Which term best describes the activities done to ensure quality output? &#8212;&#8212;&#8211;<br>CORRECT ANSWER &#8212;&#8212;&#8212; Quality control<br>Which term requires structure and a definition of acceptable standards of performance?<br>&#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; Quality planning<br>Which is represented in ALCOA-C? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; Attributable<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>ACRP PRACTICE EXAM 2023 QUESTIONSAND ANSWERSWhat are expected or possible consequences of over-estimation of recruitmentpotential? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; &#8211; The trial will overrun its projectedtimeline A trial subject informs you she no longer wants to participant in the trial. What shouldyour course of action be? &#8212;&#8212;&#8211; CORRECT ANSWER &#8212;&#8212;&#8212; You ask if the patientwishes [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[25],"tags":[],"class_list":["post-115368","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/115368","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/comments?post=115368"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/115368\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=115368"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=115368"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=115368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}