{"id":112116,"date":"2023-08-15T10:43:29","date_gmt":"2023-08-15T10:43:29","guid":{"rendered":"https:\/\/learnexams.com\/blog\/?p=112116"},"modified":"2023-08-15T10:43:32","modified_gmt":"2023-08-15T10:43:32","slug":"socra-ccrp-exam-2023-2024-actual-exam-200-questions-and-correct-detailed-answers-with-rationales-agrade","status":"publish","type":"post","link":"https:\/\/www.learnexams.com\/blog\/2023\/08\/15\/socra-ccrp-exam-2023-2024-actual-exam-200-questions-and-correct-detailed-answers-with-rationales-agrade\/","title":{"rendered":"SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES |AGRADE"},"content":{"rendered":"\n<p>SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200<br>QUESTIONS AND CORRECT DETAILED ANSWERS WITH<br>RATIONALES |AGRADE<br>When is a short form ICF needed? &#8211; ANSWER- For subjects whose first<br>language is not English<br>What are the 10 points of the Nuremberg Code? &#8211; ANSWER- &#8211; Required<br>voluntary, informed consent<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Experiment aims at positive results for society<\/li>\n\n\n\n<li>Based on previous knowledge that justifies the experiment<\/li>\n\n\n\n<li>Study design avoids unnecessary physical and mental suffering and<br>injuries<\/li>\n\n\n\n<li>Not conducted if there is any reason to believe it implies a risk of death<br>or disabling injury<\/li>\n\n\n\n<li>Risks &lt; Benefits<\/li>\n\n\n\n<li>Preparations and facilities must be provided to protect subjects against<br>risks<\/li>\n\n\n\n<li>Staff must be fully trained and qualified<\/li>\n\n\n\n<li>Subject must be free to quit at any time<\/li>\n\n\n\n<li>Medical staff stop the experiment at any time if they observe<br>continuation would be dangerous.<br>When can an investigational product be used without a signed consent? &#8211;<br>ANSWER- &#8211; in a life threatening situation<\/li>\n\n\n\n<li>inability to communicate<\/li>\n\n\n\n<li>time is not sufficient<\/li>\n\n\n\n<li>no alternate approved method available that provides an equal or<br>greater likelihood of saving the subject&#8217;s life<br>When can wards participate in a study? &#8211; ANSWER- &#8211; research related<br>to ward status<\/li>\n\n\n\n<li>conducted in an environment with majority of children are not wards<\/li>\n\n\n\n<li>advocate has best interest of child during research<\/li>\n\n\n\n<li>advocate must not be associated with guardian organization, clinical<br>investigation, or the investigator<br>How long must a Suspected Unexpected Serious Adverse Reaction<br>(SUSAR) be reported to the IRB? &#8211; ANSWER- $50,000<\/li>\n<\/ul>\n\n\n\n<p>What is considered a significant payment made from the sponsor to the<br>investigator? &#8211; ANSWER- &gt; $25,000<br>What is the main purpose of the IRB? &#8211; ANSWER- Assure protection of<br>rights, safety, and welfare of human subjects.<br>Who provides the final approval of a study?<br>a. Sponsor<br>b. FDA<br>c. IRB &#8211; ANSWER- c. IRB<br>IRB must find when approving a study: &#8211; ANSWER- &#8211; risks are<br>minimized<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>risks are reasonable for the anticipated benefits<\/li>\n\n\n\n<li>selection of subjects is equitable<\/li>\n\n\n\n<li>ICF follows guidelines<\/li>\n\n\n\n<li>ICF documented appropriately<\/li>\n\n\n\n<li>Adequate provisions for monitoring data collected to ensure the safety<br>of subjects<\/li>\n\n\n\n<li>privacy and confidentiality is protected<\/li>\n\n\n\n<li>additional safeguards in place to protect vulnerable populations<\/li>\n\n\n\n<li>copies of research proposals reviewed<\/li>\n\n\n\n<li>minutes of IRB meetings<\/li>\n\n\n\n<li>records of continuing reviews<\/li>\n\n\n\n<li>copies of correspondence between IRB and investigator<\/li>\n\n\n\n<li>list of IRB members<\/li>\n\n\n\n<li>written procedures for the IRB<\/li>\n\n\n\n<li>statement of significant findings provided to subjects &#8211; ANSWERWhat is documented at IRB meetings?<br>What are significant risk devices? &#8211; ANSWER- &#8211; implants with potential<br>serious risks<\/li>\n\n\n\n<li>used to support or sustain human life<\/li>\n\n\n\n<li>substantial importance in diagnosing, curing, or treating disease<br>What kind of investigational devices are exempt from Premarket<br>approval requirements? (IDE) &#8211; ANSWER- &#8211; diagnostic devices that are<br>non-invasive<\/li>\n\n\n\n<li>for vet or lab use<\/li>\n\n\n\n<li>custom device not intended for commercial distribution<\/li>\n\n\n\n<li>distrubuted prior to May 1976<br>Who must be part of the IRB members? &#8211; ANSWER- &#8211; males and<br>females<\/li>\n\n\n\n<li>varied background<\/li>\n\n\n\n<li>at least 5 members<\/li>\n\n\n\n<li>1 scientific background<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>SOCRA CCRP EXAM 2023-2024 ACTUAL EXAM 200QUESTIONS AND CORRECT DETAILED ANSWERS WITHRATIONALES |AGRADEWhen is a short form ICF needed? &#8211; ANSWER- For subjects whose firstlanguage is not EnglishWhat are the 10 points of the Nuremberg Code? &#8211; ANSWER- &#8211; Requiredvoluntary, informed consent What is considered a significant payment made from the sponsor to theinvestigator? &#8211; [&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-112116","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/112116","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=112116"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/112116\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=112116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=112116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=112116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}