{"id":113878,"date":"2023-08-18T03:13:56","date_gmt":"2023-08-18T03:13:56","guid":{"rendered":"https:\/\/learnexams.com\/blog\/?p=113878"},"modified":"2023-08-18T03:13:57","modified_gmt":"2023-08-18T03:13:57","slug":"acrp-ccra-exam-questions-and-answers","status":"publish","type":"post","link":"https:\/\/www.learnexams.com\/blog\/2023\/08\/18\/acrp-ccra-exam-questions-and-answers\/","title":{"rendered":"ACRP CCRA EXAM QUESTIONS AND ANSWERS"},"content":{"rendered":"\n

Who is considered “vulnerable”? – Answer- 1. prisoners<\/p>\n\n\n\n

    \n
  1. med\/nursing students<\/li>\n\n\n\n
  2. military<\/li>\n\n\n\n
  3. people in nursing homes<\/li>\n\n\n\n
  4. impoverished\/unemployed\/homeless<\/li>\n\n\n\n
  5. minors<\/li>\n\n\n\n
  6. ethnic minorities<\/li>\n\n\n\n
  7. people with incurable\/terminal illnesses
    A participant develops colon cancer (unrelated to study) and is asymptomatic. This is
    considered an SAE because colon cancer is life-threatening. True or False? – Answer\u0002FALSE
    Who is responsible for designing the protocol?
    a) PI
    b) Sponsor
    c) Institution
    d) IRB\/IEC – Answer- b) Sponsor
    You’re a study manager & one of your monitors reports significant non-compliance at a
    site. Which is your first course of action?
    a) 2nd opinion monitor visit
    b) study report
    c) root cause analysis
    d) suspension of trial – Answer- c) root cause analysis
    If attempts to secure compliance at a site have failed, should sponsor\u2026
    a) terminate the site
    b) re-train the site & develop a corrective plan – Answer- a) terminate the site
    What is “Phase IV” also known as? – Answer- Therapeutic Use
    What are ways to minimize the amount of blood drawn and\/or number of venipunctures
    from pediatric patients? – Answer- -use sensitive assays (to reduce the amt of blood
    req.)
    -use labs that are used to handling small volumes of blood to perform analyses
    -collect routine bloodwork at the same time as PK whenever possible
    -indwelling catheters
    -sparse sampling
    1 \/ 2
    -modeling adult data for pharmacokinetics
    Pharmacokinetic Phase I studies in children are generally conducted in healthy pediatric
    subjects. True or False? – Answer- FALSE
    What is the name of the assessment used to stage a youth’s pubertal development? –
    Answer- Tanner Staging
    When is an AE considered an ADR? – Answer- In pre-approved clinical settings<\/li>\n\n\n\n
  8. Either a new med product OR existing med product with new usages<\/li>\n\n\n\n
  9. Must be causal relationship
    In post-marketed products<\/li>\n\n\n\n
  10. noxious & unintended response to a drug that occurs at normal doses
    What is an unexpected ADR? – Answer- ADR that is not consistent in nature and\/or
    severity with IB
    What situations require expedited reporting to IRB? – Answer- 1. Any UNEXPECTED
    SERIOUS ADR<\/li>\n\n\n\n
  11. Increased rate of occurrence of EXPECTED SERIOUS ADR<\/li>\n\n\n\n
  12. Significant hazard to patient population (e.g. lack of efficacy of IP treating a life\u0002threatening disease)<\/li>\n\n\n\n
  13. Major safety finding from new animal study
    Expedited Reporting
    When should you report fatal\/life-threatening UNEXPECTED ADRs? – Answer- ASAP
    (no later than 7 calendar days)
    Complete full report no later than 8 days after that
    Expedited Reporting
    When should you report non-fatal\/life-threatening UNEXPECTED ADRs? – Answer\u0002ASAP (no later than 15 calendar days)
    What data should be included in an expedited report? – Answer- 1. patient info (study #,
    DOB, sex, etc.)<\/li>\n\n\n\n
  14. suspected med. products (brand, batch #, dosage form, indication, route of admin,
    etc.)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Who is considered “vulnerable”? – Answer- 1. prisoners<\/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-113878","post","type-post","status-publish","format-standard","hentry","category-exams-certification"],"_links":{"self":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/113878","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=113878"}],"version-history":[{"count":0,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/posts\/113878\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/media?parent=113878"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/categories?post=113878"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.learnexams.com\/blog\/wp-json\/wp\/v2\/tags?post=113878"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}