{"id":112184,"date":"2025-10-14T06:50:23","date_gmt":"2025-10-14T06:50:23","guid":{"rendered":"https:\/\/www.dumpsbase.com\/freedumps\/?p=112184"},"modified":"2025-10-14T06:50:23","modified_gmt":"2025-10-14T06:50:23","slug":"verified-ccrp-exam-dumps-to-demonstrate-your-expertise-pass-your-certified-clinical-research-professional-ccrp-certification-exam-smoothly","status":"publish","type":"post","link":"https:\/\/www.dumpsbase.com\/freedumps\/verified-ccrp-exam-dumps-to-demonstrate-your-expertise-pass-your-certified-clinical-research-professional-ccrp-certification-exam-smoothly.html","title":{"rendered":"Verified CCRP Exam Dumps to Demonstrate Your Expertise: Pass Your Certified Clinical Research Professional (CCRP) Certification Exam Smoothly"},"content":{"rendered":"<p>The Certified Clinical Research Professional (CCRP) program, issued by the <a href=\"https:\/\/www.dumpsbase.com\/socra.html\"><em><strong>Society of Clinical Research Associates (SOCRA)<\/strong><\/em><\/a>, is your gateway to excellence in clinical research. When preparing for your CCRP exam, you can have the verified CCRP exam dumps from DumpsBase. Those dumps are recognized as a modern and effective tool for preparing for the Certified Clinical Research Professional (CCRP) certification. With the help of these comprehensive questions equipped with approved CCRP dumps, you can accurately assess your readiness for the actual exam. The CCRP exam dumps give you genuine insight into what to expect on test day. This allows you to confidently clear the Certified Clinical Research Professional (CCRP) exam without confusion and significantly level up your professional skill set.<\/p>\n<h2>Below are the <span style=\"background-color: #cc99ff;\"><em>CCRP free dumps<\/em><\/span> for checking the quality first:<\/h2>\n<script>\n\t  window.fbAsyncInit = function() {\n\t    FB.init({\n\t      appId            : '622169541470367',\n\t      autoLogAppEvents : true,\n\t      xfbml            : true,\n\t      version          : 'v3.1'\n\t    });\n\t  };\n\t\n\t  (function(d, s, id){\n\t     var js, fjs = d.getElementsByTagName(s)[0];\n\t     if (d.getElementById(id)) {return;}\n\t     js = d.createElement(s); js.id = id;\n\t     js.src = \"https:\/\/connect.facebook.net\/en_US\/sdk.js\";\n\t     fjs.parentNode.insertBefore(js, fjs);\n\t   }(document, 'script', 'facebook-jssdk'));\n\t<\/script><script type=\"text\/javascript\" >\ndocument.addEventListener(\"DOMContentLoaded\", function(event) { \nif(!window.jQuery) alert(\"The important jQuery library is not properly loaded in your site. Your WordPress theme is probably missing the essential wp_head() call. You can switch to another theme and you will see that the plugin works fine and this notice disappears. If you are still not sure what to do you can contact us for help.\");\n});\n<\/script>  \n  \n<div  id=\"watupro_quiz\" class=\"quiz-area single-page-quiz\">\n<p id=\"submittingExam10972\" style=\"display:none;text-align:center;\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.dumpsbase.com\/freedumps\/wp-content\/plugins\/watupro\/img\/loading.gif\" width=\"16\" height=\"16\"><\/p>\n\n<div class=\"watupro-exam-description\" id=\"description-quiz-10972\"><\/div>\n\n<form action=\"\" method=\"post\" class=\"quiz-form\" id=\"quiz-10972\"  enctype=\"multipart\/form-data\" >\n<div class='watu-question ' id='question-1' style=';'><div id='questionWrap-1'  class='   watupro-question-id-432328'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>1. <\/span>In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. <br \/>\r<br>How many tablets should the subject have after the 10 days?<\/div><input type='hidden' name='question_id[]' id='qID_1' value='432328' \/><input type='hidden' id='answerType432328' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432328[]' id='answer-id-1672890' class='answer   answerof-432328 ' value='1672890'   \/><label for='answer-id-1672890' id='answer-label-1672890' class=' answer'><span>0<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432328[]' id='answer-id-1672891' class='answer   answerof-432328 ' value='1672891'   \/><label for='answer-id-1672891' id='answer-label-1672891' class=' answer'><span>1<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432328[]' id='answer-id-1672892' class='answer   answerof-432328 ' value='1672892'   \/><label for='answer-id-1672892' id='answer-label-1672892' class=' answer'><span>5<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432328[]' id='answer-id-1672893' class='answer   answerof-432328 ' value='1672893'   \/><label for='answer-id-1672893' id='answer-label-1672893' class=' answer'><span>20<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-2' style=';'><div id='questionWrap-2'  class='   watupro-question-id-432329'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>2. <\/span>When can the IRB\/IEC require that additional information be given to subjects as part of informed consent?<\/div><input type='hidden' name='question_id[]' id='qID_2' value='432329' \/><input type='hidden' id='answerType432329' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432329[]' id='answer-id-1672894' class='answer   answerof-432329 ' value='1672894'   \/><label for='answer-id-1672894' id='answer-label-1672894' class=' answer'><span>At any time, at the discretion of the IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432329[]' id='answer-id-1672895' class='answer   answerof-432329 ' value='1672895'   \/><label for='answer-id-1672895' id='answer-label-1672895' class=' answer'><span>At any time, but only if the sponsor agrees that the information is essential<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432329[]' id='answer-id-1672896' class='answer   answerof-432329 ' value='1672896'   \/><label for='answer-id-1672896' id='answer-label-1672896' class=' answer'><span>At any time, but only if the investigator agrees that the information is essential<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432329[]' id='answer-id-1672897' class='answer   answerof-432329 ' value='1672897'   \/><label for='answer-id-1672897' id='answer-label-1672897' class=' answer'><span>At any time, but only if the sponsor and investigator agree that the information is essential<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-3' style=';'><div id='questionWrap-3'  class='   watupro-question-id-432330'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>3. <\/span>1.Which of the following is an example of an additional protection required when conducting research on children?<\/div><input type='hidden' name='question_id[]' id='qID_3' value='432330' \/><input type='hidden' id='answerType432330' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432330[]' id='answer-id-1672898' class='answer   answerof-432330 ' value='1672898'   \/><label for='answer-id-1672898' id='answer-label-1672898' class=' answer'><span>There must be an impartial advocate present during the consent process<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432330[]' id='answer-id-1672899' class='answer   answerof-432330 ' value='1672899'   \/><label for='answer-id-1672899' id='answer-label-1672899' class=' answer'><span>The investigator must obtain age-appropriate assent as determined by the IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432330[]' id='answer-id-1672900' class='answer   answerof-432330 ' value='1672900'   \/><label for='answer-id-1672900' id='answer-label-1672900' class=' answer'><span>Parents must be present during all procedures<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432330[]' id='answer-id-1672901' class='answer   answerof-432330 ' value='1672901'   \/><label for='answer-id-1672901' id='answer-label-1672901' class=' answer'><span>The study must be approved by a central pediatric IRB<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-4' style=';'><div id='questionWrap-4'  class='   watupro-question-id-432331'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>4. <\/span>A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. <br \/>\r<br>How many unused test strips should the subject have after the 10 days?<\/div><input type='hidden' name='question_id[]' id='qID_4' value='432331' \/><input type='hidden' id='answerType432331' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432331[]' id='answer-id-1672902' class='answer   answerof-432331 ' value='1672902'   \/><label for='answer-id-1672902' id='answer-label-1672902' class=' answer'><span>0<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432331[]' id='answer-id-1672903' class='answer   answerof-432331 ' value='1672903'   \/><label for='answer-id-1672903' id='answer-label-1672903' class=' answer'><span>5<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432331[]' id='answer-id-1672904' class='answer   answerof-432331 ' value='1672904'   \/><label for='answer-id-1672904' id='answer-label-1672904' class=' answer'><span>31<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432331[]' id='answer-id-1672905' class='answer   answerof-432331 ' value='1672905'   \/><label for='answer-id-1672905' id='answer-label-1672905' class=' answer'><span>35<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-5' style=';'><div id='questionWrap-5'  class='   watupro-question-id-432332'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>5. <\/span>In accordance with the CFR and the ICH GCP Guideline, which of the following is directly responsible for submitting protocols and amendments to the IRB\/IEC for review?<\/div><input type='hidden' name='question_id[]' id='qID_5' value='432332' \/><input type='hidden' id='answerType432332' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432332[]' id='answer-id-1672906' class='answer   answerof-432332 ' value='1672906'   \/><label for='answer-id-1672906' id='answer-label-1672906' class=' answer'><span>The Food and Drug Administration<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432332[]' id='answer-id-1672907' class='answer   answerof-432332 ' value='1672907'   \/><label for='answer-id-1672907' id='answer-label-1672907' class=' answer'><span>The investigator<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432332[]' id='answer-id-1672908' class='answer   answerof-432332 ' value='1672908'   \/><label for='answer-id-1672908' id='answer-label-1672908' class=' answer'><span>The sponsor<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432332[]' id='answer-id-1672909' class='answer   answerof-432332 ' value='1672909'   \/><label for='answer-id-1672909' id='answer-label-1672909' class=' answer'><span>The contract research organization<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-6' style=';'><div id='questionWrap-6'  class='   watupro-question-id-432333'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>6. <\/span>In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?<\/div><input type='hidden' name='question_id[]' id='qID_6' value='432333' \/><input type='hidden' id='answerType432333' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432333[]' id='answer-id-1672910' class='answer   answerof-432333 ' value='1672910'   \/><label for='answer-id-1672910' id='answer-label-1672910' class=' answer'><span>The Investigator's Brochure<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432333[]' id='answer-id-1672911' class='answer   answerof-432333 ' value='1672911'   \/><label for='answer-id-1672911' id='answer-label-1672911' class=' answer'><span>The sponsor's written procedures<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432333[]' id='answer-id-1672912' class='answer   answerof-432333 ' value='1672912'   \/><label for='answer-id-1672912' id='answer-label-1672912' class=' answer'><span>The CRO\/site agreements<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432333[]' id='answer-id-1672913' class='answer   answerof-432333 ' value='1672913'   \/><label for='answer-id-1672913' id='answer-label-1672913' class=' answer'><span>The investigational pharmacy's requirements<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-7' style=';'><div id='questionWrap-7'  class='   watupro-question-id-432334'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>7. <\/span>Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?<\/div><input type='hidden' name='question_id[]' id='qID_7' value='432334' \/><input type='hidden' id='answerType432334' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432334[]' id='answer-id-1672914' class='answer   answerof-432334 ' value='1672914'   \/><label for='answer-id-1672914' id='answer-label-1672914' class=' answer'><span>The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432334[]' id='answer-id-1672915' class='answer   answerof-432334 ' value='1672915'   \/><label for='answer-id-1672915' id='answer-label-1672915' class=' answer'><span>The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432334[]' id='answer-id-1672916' class='answer   answerof-432334 ' value='1672916'   \/><label for='answer-id-1672916' id='answer-label-1672916' class=' answer'><span>An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432334[]' id='answer-id-1672917' class='answer   answerof-432334 ' value='1672917'   \/><label for='answer-id-1672917' id='answer-label-1672917' class=' answer'><span>The act of reviewing and approving the investigational protocol and informed consent document<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-8' style=';'><div id='questionWrap-8'  class='   watupro-question-id-432335'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>8. <\/span>On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval. <br \/>\r<br>According to the CFR, what is the earliest date when the site may begin to destroy the study records?<\/div><input type='hidden' name='question_id[]' id='qID_8' value='432335' \/><input type='hidden' id='answerType432335' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432335[]' id='answer-id-1672918' class='answer   answerof-432335 ' value='1672918'   \/><label for='answer-id-1672918' id='answer-label-1672918' class=' answer'><span>16 May 2021<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432335[]' id='answer-id-1672919' class='answer   answerof-432335 ' value='1672919'   \/><label for='answer-id-1672919' id='answer-label-1672919' class=' answer'><span>15 May 2022<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432335[]' id='answer-id-1672920' class='answer   answerof-432335 ' value='1672920'   \/><label for='answer-id-1672920' id='answer-label-1672920' class=' answer'><span>16 May 2022<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432335[]' id='answer-id-1672921' class='answer   answerof-432335 ' value='1672921'   \/><label for='answer-id-1672921' id='answer-label-1672921' class=' answer'><span>15 May 2034<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-9' style=';'><div id='questionWrap-9'  class='   watupro-question-id-432336'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>9. <\/span>An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB\/IEC. <br \/>\r<br>In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?<\/div><input type='hidden' name='question_id[]' id='qID_9' value='432336' \/><input type='hidden' id='answerType432336' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432336[]' id='answer-id-1672922' class='answer   answerof-432336 ' value='1672922'   \/><label for='answer-id-1672922' id='answer-label-1672922' class=' answer'><span>The investigator\/institution and the sponsor<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432336[]' id='answer-id-1672923' class='answer   answerof-432336 ' value='1672923'   \/><label for='answer-id-1672923' id='answer-label-1672923' class=' answer'><span>The investigator\/institution and the delegated site staff<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432336[]' id='answer-id-1672924' class='answer   answerof-432336 ' value='1672924'   \/><label for='answer-id-1672924' id='answer-label-1672924' class=' answer'><span>The sponsor and the IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432336[]' id='answer-id-1672925' class='answer   answerof-432336 ' value='1672925'   \/><label for='answer-id-1672925' id='answer-label-1672925' class=' answer'><span>The sponsor and the FDA<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-10' style=';'><div id='questionWrap-10'  class='   watupro-question-id-432337'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>10. <\/span>Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?<\/div><input type='hidden' name='question_id[]' id='qID_10' value='432337' \/><input type='hidden' id='answerType432337' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432337[]' id='answer-id-1672926' class='answer   answerof-432337 ' value='1672926'   \/><label for='answer-id-1672926' id='answer-label-1672926' class=' answer'><span>The Department of Health and Human Services<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432337[]' id='answer-id-1672927' class='answer   answerof-432337 ' value='1672927'   \/><label for='answer-id-1672927' id='answer-label-1672927' class=' answer'><span>The FDA or another regulatory authority<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432337[]' id='answer-id-1672928' class='answer   answerof-432337 ' value='1672928'   \/><label for='answer-id-1672928' id='answer-label-1672928' class=' answer'><span>The IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432337[]' id='answer-id-1672929' class='answer   answerof-432337 ' value='1672929'   \/><label for='answer-id-1672929' id='answer-label-1672929' class=' answer'><span>No approvals are necessary if no pharmaceutical drugs are involved<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-11' style=';'><div id='questionWrap-11'  class='   watupro-question-id-432338'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>11. <\/span>An approved investigational device exemption (IDE) permits a device to be:<\/div><input type='hidden' name='question_id[]' id='qID_11' value='432338' \/><input type='hidden' id='answerType432338' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432338[]' id='answer-id-1672930' class='answer   answerof-432338 ' value='1672930'   \/><label for='answer-id-1672930' id='answer-label-1672930' class=' answer'><span>Shipped lawfully for the purpose of conducting a clinical study<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432338[]' id='answer-id-1672931' class='answer   answerof-432338 ' value='1672931'   \/><label for='answer-id-1672931' id='answer-label-1672931' class=' answer'><span>Sold and marketed for profit<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432338[]' id='answer-id-1672932' class='answer   answerof-432338 ' value='1672932'   \/><label for='answer-id-1672932' id='answer-label-1672932' class=' answer'><span>Used on a patient who is not enrolled on a clinical study<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432338[]' id='answer-id-1672933' class='answer   answerof-432338 ' value='1672933'   \/><label for='answer-id-1672933' id='answer-label-1672933' class=' answer'><span>Marketed as a humanitarian device<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-12' style=';'><div id='questionWrap-12'  class='   watupro-question-id-432339'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>12. <\/span>A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. <br \/>\r<br>According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?<\/div><input type='hidden' name='question_id[]' id='qID_12' value='432339' \/><input type='hidden' id='answerType432339' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432339[]' id='answer-id-1672934' class='answer   answerof-432339 ' value='1672934'   \/><label for='answer-id-1672934' id='answer-label-1672934' class=' answer'><span>Immediately<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432339[]' id='answer-id-1672935' class='answer   answerof-432339 ' value='1672935'   \/><label for='answer-id-1672935' id='answer-label-1672935' class=' answer'><span>Within 7 working days<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432339[]' id='answer-id-1672936' class='answer   answerof-432339 ' value='1672936'   \/><label for='answer-id-1672936' id='answer-label-1672936' class=' answer'><span>Within 10 working days<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432339[]' id='answer-id-1672937' class='answer   answerof-432339 ' value='1672937'   \/><label for='answer-id-1672937' id='answer-label-1672937' class=' answer'><span>Within 15 working days<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-13' style=';'><div id='questionWrap-13'  class='   watupro-question-id-432340'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>13. <\/span>In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?<\/div><input type='hidden' name='question_id[]' id='qID_13' value='432340' \/><input type='hidden' id='answerType432340' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432340[]' id='answer-id-1672938' class='answer   answerof-432340 ' value='1672938'   \/><label for='answer-id-1672938' id='answer-label-1672938' class=' answer'><span>The addition of a new test that is intended to improve monitoring the subject for an adverse effect<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432340[]' id='answer-id-1672939' class='answer   answerof-432340 ' value='1672939'   \/><label for='answer-id-1672939' id='answer-label-1672939' class=' answer'><span>A significant change in an investigator's financial interest in the investigational product<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432340[]' id='answer-id-1672940' class='answer   answerof-432340 ' value='1672940'   \/><label for='answer-id-1672940' id='answer-label-1672940' class=' answer'><span>The addition of a sub-investigator with the scientific training and expertise to conduct the investigation<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432340[]' id='answer-id-1672941' class='answer   answerof-432340 ' value='1672941'   \/><label for='answer-id-1672941' id='answer-label-1672941' class=' answer'><span>A change in the manufacturing site for the investigational product<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-14' style=';'><div id='questionWrap-14'  class='   watupro-question-id-432341'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>14. <\/span>A sponsor's monitor is conducting a site selection visit for an interventional drug trial. <br \/>\r<br>In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?<\/div><input type='hidden' name='question_id[]' id='qID_14' value='432341' \/><input type='hidden' id='answerType432341' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432341[]' id='answer-id-1672942' class='answer   answerof-432341 ' value='1672942'   \/><label for='answer-id-1672942' id='answer-label-1672942' class=' answer'><span>Number of staff members<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432341[]' id='answer-id-1672943' class='answer   answerof-432341 ' value='1672943'   \/><label for='answer-id-1672943' id='answer-label-1672943' class=' answer'><span>Available storage square footage<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432341[]' id='answer-id-1672944' class='answer   answerof-432341 ' value='1672944'   \/><label for='answer-id-1672944' id='answer-label-1672944' class=' answer'><span>Storage facility temperature range<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432341[]' id='answer-id-1672945' class='answer   answerof-432341 ' value='1672945'   \/><label for='answer-id-1672945' id='answer-label-1672945' class=' answer'><span>Storage cost<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-15' style=';'><div id='questionWrap-15'  class='   watupro-question-id-432342'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>15. <\/span>An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety. <br \/>\r<br>Which of the following parties, if any, is the investigator required to notify?<\/div><input type='hidden' name='question_id[]' id='qID_15' value='432342' \/><input type='hidden' id='answerType432342' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432342[]' id='answer-id-1672946' class='answer   answerof-432342 ' value='1672946'   \/><label for='answer-id-1672946' id='answer-label-1672946' class=' answer'><span>The IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432342[]' id='answer-id-1672947' class='answer   answerof-432342 ' value='1672947'   \/><label for='answer-id-1672947' id='answer-label-1672947' class=' answer'><span>The Data Safety Monitoring Board (DSMB)<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432342[]' id='answer-id-1672948' class='answer   answerof-432342 ' value='1672948'   \/><label for='answer-id-1672948' id='answer-label-1672948' class=' answer'><span>The regulatory authority<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432342[]' id='answer-id-1672949' class='answer   answerof-432342 ' value='1672949'   \/><label for='answer-id-1672949' id='answer-label-1672949' class=' answer'><span>No notification is required<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-16' style=';'><div id='questionWrap-16'  class='   watupro-question-id-432343'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>16. <\/span>In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?<\/div><input type='hidden' name='question_id[]' id='qID_16' value='432343' \/><input type='hidden' id='answerType432343' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432343[]' id='answer-id-1672950' class='answer   answerof-432343 ' value='1672950'   \/><label for='answer-id-1672950' id='answer-label-1672950' class=' answer'><span>An initial review and approval of a trial<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432343[]' id='answer-id-1672951' class='answer   answerof-432343 ' value='1672951'   \/><label for='answer-id-1672951' id='answer-label-1672951' class=' answer'><span>Recommendations to stop a trial<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432343[]' id='answer-id-1672952' class='answer   answerof-432343 ' value='1672952'   \/><label for='answer-id-1672952' id='answer-label-1672952' class=' answer'><span>Suggestions for a new trial design<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432343[]' id='answer-id-1672953' class='answer   answerof-432343 ' value='1672953'   \/><label for='answer-id-1672953' id='answer-label-1672953' class=' answer'><span>The selection of qualified investigators<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-17' style=';'><div id='questionWrap-17'  class='   watupro-question-id-432344'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>17. <\/span>During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:<\/div><input type='hidden' name='question_id[]' id='qID_17' value='432344' \/><input type='hidden' id='answerType432344' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432344[]' id='answer-id-1672954' class='answer   answerof-432344 ' value='1672954'   \/><label for='answer-id-1672954' id='answer-label-1672954' class=' answer'><span>Suspend all trial-related activities until the events of the deviation have been mitigated<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432344[]' id='answer-id-1672955' class='answer   answerof-432344 ' value='1672955'   \/><label for='answer-id-1672955' id='answer-label-1672955' class=' answer'><span>Document and explain the deviation from the protocol<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432344[]' id='answer-id-1672956' class='answer   answerof-432344 ' value='1672956'   \/><label for='answer-id-1672956' id='answer-label-1672956' class=' answer'><span>Assign another investigator to perform sample collections until an internal investigation is completed<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432344[]' id='answer-id-1672957' class='answer   answerof-432344 ' value='1672957'   \/><label for='answer-id-1672957' id='answer-label-1672957' class=' answer'><span>Immediately report the observation to the regulatory authority<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-18' style=';'><div id='questionWrap-18'  class='   watupro-question-id-432345'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>18. <\/span>Which of the following would be considered an addendum to an investigator's brochure for an unapproved Investigational Product?<\/div><input type='hidden' name='question_id[]' id='qID_18' value='432345' \/><input type='hidden' id='answerType432345' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432345[]' id='answer-id-1672958' class='answer   answerof-432345 ' value='1672958'   \/><label for='answer-id-1672958' id='answer-label-1672958' class=' answer'><span>Revisions to the risk section of the informed consent form<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432345[]' id='answer-id-1672959' class='answer   answerof-432345 ' value='1672959'   \/><label for='answer-id-1672959' id='answer-label-1672959' class=' answer'><span>A Suspected Unexpected Serious Adverse Reaction (SUSAR) report<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432345[]' id='answer-id-1672960' class='answer   answerof-432345 ' value='1672960'   \/><label for='answer-id-1672960' id='answer-label-1672960' class=' answer'><span>A site-specific SAE report<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432345[]' id='answer-id-1672961' class='answer   answerof-432345 ' value='1672961'   \/><label for='answer-id-1672961' id='answer-label-1672961' class=' answer'><span>Product monograph updates<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-19' style=';'><div id='questionWrap-19'  class='   watupro-question-id-432346'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>19. <\/span>According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB after completion of the trial at the site?<\/div><input type='hidden' name='question_id[]' id='qID_19' value='432346' \/><input type='hidden' id='answerType432346' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432346[]' id='answer-id-1672962' class='answer   answerof-432346 ' value='1672962'   \/><label for='answer-id-1672962' id='answer-label-1672962' class=' answer'><span>The final report<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432346[]' id='answer-id-1672963' class='answer   answerof-432346 ' value='1672963'   \/><label for='answer-id-1672963' id='answer-label-1672963' class=' answer'><span>The monitoring close-out visit report<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432346[]' id='answer-id-1672964' class='answer   answerof-432346 ' value='1672964'   \/><label for='answer-id-1672964' id='answer-label-1672964' class=' answer'><span>The data safety monitoring summary<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432346[]' id='answer-id-1672965' class='answer   answerof-432346 ' value='1672965'   \/><label for='answer-id-1672965' id='answer-label-1672965' class=' answer'><span>The final subject enrollment log<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-20' style=';'><div id='questionWrap-20'  class='   watupro-question-id-432347'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>20. <\/span>Before approving a research protocol, an IRB\/IEC must determine compliance with which of the following requirements?<\/div><input type='hidden' name='question_id[]' id='qID_20' value='432347' \/><input type='hidden' id='answerType432347' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432347[]' id='answer-id-1672966' class='answer   answerof-432347 ' value='1672966'   \/><label for='answer-id-1672966' id='answer-label-1672966' class=' answer'><span>A plan for the publication of study results is in place<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432347[]' id='answer-id-1672967' class='answer   answerof-432347 ' value='1672967'   \/><label for='answer-id-1672967' id='answer-label-1672967' class=' answer'><span>The selection of subjects is equitable<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432347[]' id='answer-id-1672968' class='answer   answerof-432347 ' value='1672968'   \/><label for='answer-id-1672968' id='answer-label-1672968' class=' answer'><span>The investigator has adequate access to patients eligible for the trial<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432347[]' id='answer-id-1672969' class='answer   answerof-432347 ' value='1672969'   \/><label for='answer-id-1672969' id='answer-label-1672969' class=' answer'><span>The sponsor is qualified to provide oversight of the trial<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-21' style=';'><div id='questionWrap-21'  class='   watupro-question-id-432348'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>21. <\/span>A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional institutional training. <br \/>\r<br>According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in the regulatory binder?<\/div><input type='hidden' name='question_id[]' id='qID_21' value='432348' \/><input type='hidden' id='answerType432348' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432348[]' id='answer-id-1672970' class='answer   answerof-432348 ' value='1672970'   \/><label for='answer-id-1672970' id='answer-label-1672970' class=' answer'><span>The letter documenting the promotion to a CRC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432348[]' id='answer-id-1672971' class='answer   answerof-432348 ' value='1672971'   \/><label for='answer-id-1672971' id='answer-label-1672971' class=' answer'><span>A brochure from the training course<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432348[]' id='answer-id-1672972' class='answer   answerof-432348 ' value='1672972'   \/><label for='answer-id-1672972' id='answer-label-1672972' class=' answer'><span>An updated performance review summary<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432348[]' id='answer-id-1672973' class='answer   answerof-432348 ' value='1672973'   \/><label for='answer-id-1672973' id='answer-label-1672973' class=' answer'><span>An updated curriculum vitae<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-22' style=';'><div id='questionWrap-22'  class='   watupro-question-id-432349'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>22. <\/span>A physician wants to conduct research using an approved\/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. <br \/>\r<br>In this case, the physician must obtain which of the following?<\/div><input type='hidden' name='question_id[]' id='qID_22' value='432349' \/><input type='hidden' id='answerType432349' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432349[]' id='answer-id-1672974' class='answer   answerof-432349 ' value='1672974'   \/><label for='answer-id-1672974' id='answer-label-1672974' class=' answer'><span>The Office for Human Research Protections (OHRP) and manufacturer approvals<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432349[]' id='answer-id-1672975' class='answer   answerof-432349 ' value='1672975'   \/><label for='answer-id-1672975' id='answer-label-1672975' class=' answer'><span>IRB\/IEC approval and an FDA IND<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432349[]' id='answer-id-1672976' class='answer   answerof-432349 ' value='1672976'   \/><label for='answer-id-1672976' id='answer-label-1672976' class=' answer'><span>IRB\/IEC approval and an FDA IDE<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432349[]' id='answer-id-1672977' class='answer   answerof-432349 ' value='1672977'   \/><label for='answer-id-1672977' id='answer-label-1672977' class=' answer'><span>IRB\/IEC and manufacturer approval<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-23' style=';'><div id='questionWrap-23'  class='   watupro-question-id-432350'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>23. <\/span>A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. <br \/>\r<br>In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB\/IEC?<\/div><input type='hidden' name='question_id[]' id='qID_23' value='432350' \/><input type='hidden' id='answerType432350' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432350[]' id='answer-id-1672978' class='answer   answerof-432350 ' value='1672978'   \/><label for='answer-id-1672978' id='answer-label-1672978' class=' answer'><span>Proof of citizenship<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432350[]' id='answer-id-1672979' class='answer   answerof-432350 ' value='1672979'   \/><label for='answer-id-1672979' id='answer-label-1672979' class=' answer'><span>A letter of recommendation from a fellow physician<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432350[]' id='answer-id-1672980' class='answer   answerof-432350 ' value='1672980'   \/><label for='answer-id-1672980' id='answer-label-1672980' class=' answer'><span>A curriculum vitae<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432350[]' id='answer-id-1672981' class='answer   answerof-432350 ' value='1672981'   \/><label for='answer-id-1672981' id='answer-label-1672981' class=' answer'><span>A copy of medical license<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-24' style=';'><div id='questionWrap-24'  class='   watupro-question-id-432351'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>24. <\/span>In determining the classification of risk for a study involving a medical device, it is necessary to consider the:<\/div><input type='hidden' name='question_id[]' id='qID_24' value='432351' \/><input type='hidden' id='answerType432351' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432351[]' id='answer-id-1672982' class='answer   answerof-432351 ' value='1672982'   \/><label for='answer-id-1672982' id='answer-label-1672982' class=' answer'><span>Number of patients to be treated with the device<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432351[]' id='answer-id-1672983' class='answer   answerof-432351 ' value='1672983'   \/><label for='answer-id-1672983' id='answer-label-1672983' class=' answer'><span>Cost of device<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432351[]' id='answer-id-1672984' class='answer   answerof-432351 ' value='1672984'   \/><label for='answer-id-1672984' id='answer-label-1672984' class=' answer'><span>Investigators\u2019 prior training and experience<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432351[]' id='answer-id-1672985' class='answer   answerof-432351 ' value='1672985'   \/><label for='answer-id-1672985' id='answer-label-1672985' class=' answer'><span>Use of the device in the particular study<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-25' style=';'><div id='questionWrap-25'  class='   watupro-question-id-432352'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>25. <\/span>The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?<\/div><input type='hidden' name='question_id[]' id='qID_25' value='432352' \/><input type='hidden' id='answerType432352' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432352[]' id='answer-id-1672986' class='answer   answerof-432352 ' value='1672986'   \/><label for='answer-id-1672986' id='answer-label-1672986' class=' answer'><span>The sponsor failed to submit an accurate annual report of the study to the FDA<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432352[]' id='answer-id-1672987' class='answer   answerof-432352 ' value='1672987'   \/><label for='answer-id-1672987' id='answer-label-1672987' class=' answer'><span>The reviewing IRB\/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432352[]' id='answer-id-1672988' class='answer   answerof-432352 ' value='1672988'   \/><label for='answer-id-1672988' id='answer-label-1672988' class=' answer'><span>An investigator failed to submit safety reports to the FDA<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432352[]' id='answer-id-1672989' class='answer   answerof-432352 ' value='1672989'   \/><label for='answer-id-1672989' id='answer-label-1672989' class=' answer'><span>The FDA issued a clinical hold, and 30 days have elapsed<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-26' style=';'><div id='questionWrap-26'  class='   watupro-question-id-432353'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>26. <\/span>In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:<\/div><input type='hidden' name='question_id[]' id='qID_26' value='432353' \/><input type='hidden' id='answerType432353' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432353[]' id='answer-id-1672990' class='answer   answerof-432353 ' value='1672990'   \/><label for='answer-id-1672990' id='answer-label-1672990' class=' answer'><span>2 years<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432353[]' id='answer-id-1672991' class='answer   answerof-432353 ' value='1672991'   \/><label for='answer-id-1672991' id='answer-label-1672991' class=' answer'><span>3 years<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432353[]' id='answer-id-1672992' class='answer   answerof-432353 ' value='1672992'   \/><label for='answer-id-1672992' id='answer-label-1672992' class=' answer'><span>5 years<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432353[]' id='answer-id-1672993' class='answer   answerof-432353 ' value='1672993'   \/><label for='answer-id-1672993' id='answer-label-1672993' class=' answer'><span>15 years<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-27' style=';'><div id='questionWrap-27'  class='   watupro-question-id-432354'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>27. <\/span>In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB\/IEC will conduct the initial and continuing review of a study?<\/div><input type='hidden' name='question_id[]' id='qID_27' value='432354' \/><input type='hidden' id='answerType432354' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432354[]' id='answer-id-1672994' class='answer   answerof-432354 ' value='1672994'   \/><label for='answer-id-1672994' id='answer-label-1672994' class=' answer'><span>The sponsor<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432354[]' id='answer-id-1672995' class='answer   answerof-432354 ' value='1672995'   \/><label for='answer-id-1672995' id='answer-label-1672995' class=' answer'><span>The monitor<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432354[]' id='answer-id-1672996' class='answer   answerof-432354 ' value='1672996'   \/><label for='answer-id-1672996' id='answer-label-1672996' class=' answer'><span>The investigator<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432354[]' id='answer-id-1672997' class='answer   answerof-432354 ' value='1672997'   \/><label for='answer-id-1672997' id='answer-label-1672997' class=' answer'><span>The study coordinator<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-28' style=';'><div id='questionWrap-28'  class='   watupro-question-id-432355'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>28. <\/span>A clinical investigator terminated a Phase IV drug study. <br \/>\r<br>In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?<\/div><input type='hidden' name='question_id[]' id='qID_28' value='432355' \/><input type='hidden' id='answerType432355' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432355[]' id='answer-id-1672998' class='answer   answerof-432355 ' value='1672998'   \/><label for='answer-id-1672998' id='answer-label-1672998' class=' answer'><span>The master randomization list<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432355[]' id='answer-id-1672999' class='answer   answerof-432355 ' value='1672999'   \/><label for='answer-id-1672999' id='answer-label-1672999' class=' answer'><span>The completed subject identification code list<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432355[]' id='answer-id-1673000' class='answer   answerof-432355 ' value='1673000'   \/><label for='answer-id-1673000' id='answer-label-1673000' class=' answer'><span>The final trial closeout monitoring report<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432355[]' id='answer-id-1673001' class='answer   answerof-432355 ' value='1673001'   \/><label for='answer-id-1673001' id='answer-label-1673001' class=' answer'><span>The audit certificate<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-29' style=';'><div id='questionWrap-29'  class='   watupro-question-id-432356'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>29. <\/span>In accordance with the Belmont Report, obtaining voluntary informed consent from subjects prior to enrolling them in a clinical trial is an example of which of the following ethical principles?<\/div><input type='hidden' name='question_id[]' id='qID_29' value='432356' \/><input type='hidden' id='answerType432356' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432356[]' id='answer-id-1673002' class='answer   answerof-432356 ' value='1673002'   \/><label for='answer-id-1673002' id='answer-label-1673002' class=' answer'><span>Do no harm<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432356[]' id='answer-id-1673003' class='answer   answerof-432356 ' value='1673003'   \/><label for='answer-id-1673003' id='answer-label-1673003' class=' answer'><span>Respect for persons<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432356[]' id='answer-id-1673004' class='answer   answerof-432356 ' value='1673004'   \/><label for='answer-id-1673004' id='answer-label-1673004' class=' answer'><span>Beneficence<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432356[]' id='answer-id-1673005' class='answer   answerof-432356 ' value='1673005'   \/><label for='answer-id-1673005' id='answer-label-1673005' class=' answer'><span>Justice<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-30' style=';'><div id='questionWrap-30'  class='   watupro-question-id-432357'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>30. <\/span>A nonrandomized study of 30 subjects entitled &quot;A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis&quot; is an example of a:<\/div><input type='hidden' name='question_id[]' id='qID_30' value='432357' \/><input type='hidden' id='answerType432357' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432357[]' id='answer-id-1673006' class='answer   answerof-432357 ' value='1673006'   \/><label for='answer-id-1673006' id='answer-label-1673006' class=' answer'><span>Phase I<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432357[]' id='answer-id-1673007' class='answer   answerof-432357 ' value='1673007'   \/><label for='answer-id-1673007' id='answer-label-1673007' class=' answer'><span>Phase II<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432357[]' id='answer-id-1673008' class='answer   answerof-432357 ' value='1673008'   \/><label for='answer-id-1673008' id='answer-label-1673008' class=' answer'><span>Phase III<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432357[]' id='answer-id-1673009' class='answer   answerof-432357 ' value='1673009'   \/><label for='answer-id-1673009' id='answer-label-1673009' class=' answer'><span>Phase IV<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-31' style=';'><div id='questionWrap-31'  class='   watupro-question-id-432358'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>31. <\/span>For a study with a significant risk investigational medical device that could optimize the effects of radiation therapy on cancer tumors, the investigational plan states mild burns are an anticipated effect. One subject developed severe burns with blistering. <br \/>\r<br>In accordance with the CFR, this effect must be reported to the sponsor and the IRB\/IEC as soon as possible and at most how long after the investigator first learns of the effect?<\/div><input type='hidden' name='question_id[]' id='qID_31' value='432358' \/><input type='hidden' id='answerType432358' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432358[]' id='answer-id-1673010' class='answer   answerof-432358 ' value='1673010'   \/><label for='answer-id-1673010' id='answer-label-1673010' class=' answer'><span>2 working days<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432358[]' id='answer-id-1673011' class='answer   answerof-432358 ' value='1673011'   \/><label for='answer-id-1673011' id='answer-label-1673011' class=' answer'><span>5 working days<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432358[]' id='answer-id-1673012' class='answer   answerof-432358 ' value='1673012'   \/><label for='answer-id-1673012' id='answer-label-1673012' class=' answer'><span>7 working days<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432358[]' id='answer-id-1673013' class='answer   answerof-432358 ' value='1673013'   \/><label for='answer-id-1673013' id='answer-label-1673013' class=' answer'><span>10 working days<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-32' style=';'><div id='questionWrap-32'  class='   watupro-question-id-432359'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>32. <\/span>Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?<\/div><input type='hidden' name='question_id[]' id='qID_32' value='432359' \/><input type='hidden' id='answerType432359' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432359[]' id='answer-id-1673014' class='answer   answerof-432359 ' value='1673014'   \/><label for='answer-id-1673014' id='answer-label-1673014' class=' answer'><span>The Nuremberg Code<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432359[]' id='answer-id-1673015' class='answer   answerof-432359 ' value='1673015'   \/><label for='answer-id-1673015' id='answer-label-1673015' class=' answer'><span>The Declaration of Helsinki<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432359[]' id='answer-id-1673016' class='answer   answerof-432359 ' value='1673016'   \/><label for='answer-id-1673016' id='answer-label-1673016' class=' answer'><span>The ICH Guidelines<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432359[]' id='answer-id-1673017' class='answer   answerof-432359 ' value='1673017'   \/><label for='answer-id-1673017' id='answer-label-1673017' class=' answer'><span>The Belmont Report<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-33' style=';'><div id='questionWrap-33'  class='   watupro-question-id-432360'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>33. <\/span>A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. <br \/>\r<br>According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?<\/div><input type='hidden' name='question_id[]' id='qID_33' value='432360' \/><input type='hidden' id='answerType432360' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432360[]' id='answer-id-1673018' class='answer   answerof-432360 ' value='1673018'   \/><label for='answer-id-1673018' id='answer-label-1673018' class=' answer'><span>The sponsor<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432360[]' id='answer-id-1673019' class='answer   answerof-432360 ' value='1673019'   \/><label for='answer-id-1673019' id='answer-label-1673019' class=' answer'><span>The investigator\/institution<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432360[]' id='answer-id-1673020' class='answer   answerof-432360 ' value='1673020'   \/><label for='answer-id-1673020' id='answer-label-1673020' class=' answer'><span>The IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432360[]' id='answer-id-1673021' class='answer   answerof-432360 ' value='1673021'   \/><label for='answer-id-1673021' id='answer-label-1673021' class=' answer'><span>The external source<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-34' style=';'><div id='questionWrap-34'  class='   watupro-question-id-432361'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>34. <\/span>A subject enrolled in a drug clinical trial has withdrawn from the study. <br \/>\r<br>In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?<\/div><input type='hidden' name='question_id[]' id='qID_34' value='432361' \/><input type='hidden' id='answerType432361' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432361[]' id='answer-id-1673022' class='answer   answerof-432361 ' value='1673022'   \/><label for='answer-id-1673022' id='answer-label-1673022' class=' answer'><span>The data safety monitoring plan<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432361[]' id='answer-id-1673023' class='answer   answerof-432361 ' value='1673023'   \/><label for='answer-id-1673023' id='answer-label-1673023' class=' answer'><span>The protocol<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432361[]' id='answer-id-1673024' class='answer   answerof-432361 ' value='1673024'   \/><label for='answer-id-1673024' id='answer-label-1673024' class=' answer'><span>The Investigator's Brochure<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432361[]' id='answer-id-1673025' class='answer   answerof-432361 ' value='1673025'   \/><label for='answer-id-1673025' id='answer-label-1673025' class=' answer'><span>The informed consent document<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-35' style=';'><div id='questionWrap-35'  class='   watupro-question-id-432362'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>35. <\/span>Which of the following adverse events occurring during a study of an investigational new drug would require the sponsor to notify the FDA as soon as possible but in no case later than seven calendar days after the initial receipt of the information?<\/div><input type='hidden' name='question_id[]' id='qID_35' value='432362' \/><input type='hidden' id='answerType432362' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432362[]' id='answer-id-1673026' class='answer   answerof-432362 ' value='1673026'   \/><label for='answer-id-1673026' id='answer-label-1673026' class=' answer'><span>Aplastic anemia requiring hospitalization, mentioned in the investigator's brochure<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432362[]' id='answer-id-1673027' class='answer   answerof-432362 ' value='1673027'   \/><label for='answer-id-1673027' id='answer-label-1673027' class=' answer'><span>An infection not related to the investigational drug requiring hospitalization for antibiotic therapy<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432362[]' id='answer-id-1673028' class='answer   answerof-432362 ' value='1673028'   \/><label for='answer-id-1673028' id='answer-label-1673028' class=' answer'><span>Death as a result of arrhythmias (irregular heart rhythm), not mentioned in the investigator's brochure and thought to be related to the use of the drug<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432362[]' id='answer-id-1673029' class='answer   answerof-432362 ' value='1673029'   \/><label for='answer-id-1673029' id='answer-label-1673029' class=' answer'><span>Death due to disease progression, mentioned in the investigator's brochure<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-36' style=';'><div id='questionWrap-36'  class='   watupro-question-id-432363'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>36. <\/span>Which of the following identifies content that should be included in a clinical research protocol?<\/div><input type='hidden' name='question_id[]' id='qID_36' value='432363' \/><input type='hidden' id='answerType432363' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432363[]' id='answer-id-1673030' class='answer   answerof-432363 ' value='1673030'   \/><label for='answer-id-1673030' id='answer-label-1673030' class=' answer'><span>IRB\/IEC approval and meeting minutes<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432363[]' id='answer-id-1673031' class='answer   answerof-432363 ' value='1673031'   \/><label for='answer-id-1673031' id='answer-label-1673031' class=' answer'><span>Standard operating procedures for data collection<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432363[]' id='answer-id-1673032' class='answer   answerof-432363 ' value='1673032'   \/><label for='answer-id-1673032' id='answer-label-1673032' class=' answer'><span>Criteria for the selection of an investigator<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432363[]' id='answer-id-1673033' class='answer   answerof-432363 ' value='1673033'   \/><label for='answer-id-1673033' id='answer-label-1673033' class=' answer'><span>A summary of findings of nonclinical studies that potentially have clinical significance<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-37' style=';'><div id='questionWrap-37'  class='   watupro-question-id-432364'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>37. <\/span>In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties and functions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?<\/div><input type='hidden' name='question_id[]' id='qID_37' value='432364' \/><input type='hidden' id='answerType432364' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432364[]' id='answer-id-1673034' class='answer   answerof-432364 ' value='1673034'   \/><label for='answer-id-1673034' id='answer-label-1673034' class=' answer'><span>The investigator<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432364[]' id='answer-id-1673035' class='answer   answerof-432364 ' value='1673035'   \/><label for='answer-id-1673035' id='answer-label-1673035' class=' answer'><span>The IRB\/IEC<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432364[]' id='answer-id-1673036' class='answer   answerof-432364 ' value='1673036'   \/><label for='answer-id-1673036' id='answer-label-1673036' class=' answer'><span>The CRO<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432364[]' id='answer-id-1673037' class='answer   answerof-432364 ' value='1673037'   \/><label for='answer-id-1673037' id='answer-label-1673037' class=' answer'><span>The sponsor<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-38' style=';'><div id='questionWrap-38'  class='   watupro-question-id-432365'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>38. <\/span>In accordance with the CFR, the IRB\/IEC membership must have:<\/div><input type='hidden' name='question_id[]' id='qID_38' value='432365' \/><input type='hidden' id='answerType432365' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432365[]' id='answer-id-1673038' class='answer   answerof-432365 ' value='1673038'   \/><label for='answer-id-1673038' id='answer-label-1673038' class=' answer'><span>At least seven individuals<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432365[]' id='answer-id-1673039' class='answer   answerof-432365 ' value='1673039'   \/><label for='answer-id-1673039' id='answer-label-1673039' class=' answer'><span>A majority of individuals whose primary area of expertise is nonscientific<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432365[]' id='answer-id-1673040' class='answer   answerof-432365 ' value='1673040'   \/><label for='answer-id-1673040' id='answer-label-1673040' class=' answer'><span>At least one cleric<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432365[]' id='answer-id-1673041' class='answer   answerof-432365 ' value='1673041'   \/><label for='answer-id-1673041' id='answer-label-1673041' class=' answer'><span>At least one individual who is not affiliated with the institution<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-39' style=';'><div id='questionWrap-39'  class='   watupro-question-id-432366'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>39. <\/span>A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?<\/div><input type='hidden' name='question_id[]' id='qID_39' value='432366' \/><input type='hidden' id='answerType432366' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432366[]' id='answer-id-1673042' class='answer   answerof-432366 ' value='1673042'   \/><label for='answer-id-1673042' id='answer-label-1673042' class=' answer'><span>Lab draw requirements<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432366[]' id='answer-id-1673043' class='answer   answerof-432366 ' value='1673043'   \/><label for='answer-id-1673043' id='answer-label-1673043' class=' answer'><span>Results of recent nude mouse study<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432366[]' id='answer-id-1673044' class='answer   answerof-432366 ' value='1673044'   \/><label for='answer-id-1673044' id='answer-label-1673044' class=' answer'><span>Dispensing instructions<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432366[]' id='answer-id-1673045' class='answer   answerof-432366 ' value='1673045'   \/><label for='answer-id-1673045' id='answer-label-1673045' class=' answer'><span>Schedule of events<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-40' style=';'><div id='questionWrap-40'  class='   watupro-question-id-432367'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>40. <\/span>In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?<\/div><input type='hidden' name='question_id[]' id='qID_40' value='432367' \/><input type='hidden' id='answerType432367' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432367[]' id='answer-id-1673046' class='answer   answerof-432367 ' value='1673046'   \/><label for='answer-id-1673046' id='answer-label-1673046' class=' answer'><span>One year<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432367[]' id='answer-id-1673047' class='answer   answerof-432367 ' value='1673047'   \/><label for='answer-id-1673047' id='answer-label-1673047' class=' answer'><span>Two years<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432367[]' id='answer-id-1673048' class='answer   answerof-432367 ' value='1673048'   \/><label for='answer-id-1673048' id='answer-label-1673048' class=' answer'><span>Three years<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432367[]' id='answer-id-1673049' class='answer   answerof-432367 ' value='1673049'   \/><label for='answer-id-1673049' id='answer-label-1673049' class=' answer'><span>Five years<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-41' style=';'><div id='questionWrap-41'  class='   watupro-question-id-432368'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>41. <\/span>A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. <br \/>\r<br>Where can the sub-investigator find a description of the unblinding procedure?<\/div><input type='hidden' name='question_id[]' id='qID_41' value='432368' \/><input type='hidden' id='answerType432368' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432368[]' id='answer-id-1673050' class='answer   answerof-432368 ' value='1673050'   \/><label for='answer-id-1673050' id='answer-label-1673050' class=' answer'><span>The informed consent form<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432368[]' id='answer-id-1673051' class='answer   answerof-432368 ' value='1673051'   \/><label for='answer-id-1673051' id='answer-label-1673051' class=' answer'><span>The Investigator's Brochure<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432368[]' id='answer-id-1673052' class='answer   answerof-432368 ' value='1673052'   \/><label for='answer-id-1673052' id='answer-label-1673052' class=' answer'><span>The study protocol<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432368[]' id='answer-id-1673053' class='answer   answerof-432368 ' value='1673053'   \/><label for='answer-id-1673053' id='answer-label-1673053' class=' answer'><span>The case report form<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-42' style=';'><div id='questionWrap-42'  class='   watupro-question-id-432369'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>42. <\/span>Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?<\/div><input type='hidden' name='question_id[]' id='qID_42' value='432369' \/><input type='hidden' id='answerType432369' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432369[]' id='answer-id-1673054' class='answer   answerof-432369 ' value='1673054'   \/><label for='answer-id-1673054' id='answer-label-1673054' class=' answer'><span>It is an application to export the investigational drug<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432369[]' id='answer-id-1673055' class='answer   answerof-432369 ' value='1673055'   \/><label for='answer-id-1673055' id='answer-label-1673055' class=' answer'><span>It includes the rationale for human testing and a description of the general investigational plan<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432369[]' id='answer-id-1673056' class='answer   answerof-432369 ' value='1673056'   \/><label for='answer-id-1673056' id='answer-label-1673056' class=' answer'><span>It is an application for the sponsor to sell the drug for profit<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432369[]' id='answer-id-1673057' class='answer   answerof-432369 ' value='1673057'   \/><label for='answer-id-1673057' id='answer-label-1673057' class=' answer'><span>It includes a disclosure of the financial interests and arrangements of clinical investigators<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-43' style=';'><div id='questionWrap-43'  class='   watupro-question-id-432370'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>43. <\/span>In accordance with 45 CFR 46, in addition to the Office for Human Research Protections (OHRP), a suspension of IRB\/IEC approval must be reported to which of the following?<\/div><input type='hidden' name='question_id[]' id='qID_43' value='432370' \/><input type='hidden' id='answerType432370' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432370[]' id='answer-id-1673058' class='answer   answerof-432370 ' value='1673058'   \/><label for='answer-id-1673058' id='answer-label-1673058' class=' answer'><span>The local hospital's bioethics committee<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432370[]' id='answer-id-1673059' class='answer   answerof-432370 ' value='1673059'   \/><label for='answer-id-1673059' id='answer-label-1673059' class=' answer'><span>The appropriate institutional officials<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432370[]' id='answer-id-1673060' class='answer   answerof-432370 ' value='1673060'   \/><label for='answer-id-1673060' id='answer-label-1673060' class=' answer'><span>The Scientific Review Committee<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432370[]' id='answer-id-1673061' class='answer   answerof-432370 ' value='1673061'   \/><label for='answer-id-1673061' id='answer-label-1673061' class=' answer'><span>The local hospital's medical director<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-44' style=';'><div id='questionWrap-44'  class='   watupro-question-id-432371'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>44. <\/span>Which of the following is considered a source document?<\/div><input type='hidden' name='question_id[]' id='qID_44' value='432371' \/><input type='hidden' id='answerType432371' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432371[]' id='answer-id-1673062' class='answer   answerof-432371 ' value='1673062'   \/><label for='answer-id-1673062' id='answer-label-1673062' class=' answer'><span>The subject instruction sheet<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432371[]' id='answer-id-1673063' class='answer   answerof-432371 ' value='1673063'   \/><label for='answer-id-1673063' id='answer-label-1673063' class=' answer'><span>Standard operating procedures (SOPs)<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432371[]' id='answer-id-1673064' class='answer   answerof-432371 ' value='1673064'   \/><label for='answer-id-1673064' id='answer-label-1673064' class=' answer'><span>The protocol<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432371[]' id='answer-id-1673065' class='answer   answerof-432371 ' value='1673065'   \/><label for='answer-id-1673065' id='answer-label-1673065' class=' answer'><span>Pharmacy dispensing records<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div class='watu-question ' id='question-45' style=';'><div id='questionWrap-45'  class='   watupro-question-id-432372'>\n\t\t\t<div class='question-content'><div><span class='watupro_num'>45. <\/span>In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?<\/div><input type='hidden' name='question_id[]' id='qID_45' value='432372' \/><input type='hidden' id='answerType432372' value='radio'><!-- end question-content--><\/div><div class='question-choices watupro-choices-columns '><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432372[]' id='answer-id-1673066' class='answer   answerof-432372 ' value='1673066'   \/><label for='answer-id-1673066' id='answer-label-1673066' class=' answer'><span>Overseeing the administration of the investigational drug to the subjects<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432372[]' id='answer-id-1673067' class='answer   answerof-432372 ' value='1673067'   \/><label for='answer-id-1673067' id='answer-label-1673067' class=' answer'><span>Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432372[]' id='answer-id-1673068' class='answer   answerof-432372 ' value='1673068'   \/><label for='answer-id-1673068' id='answer-label-1673068' class=' answer'><span>Maintaining case histories that record all observations and other data pertinent to the investigation<\/span><\/label><\/div><div class='watupro-question-choice  ' dir='auto' ><input type='radio' name='answer-432372[]' id='answer-id-1673069' class='answer   answerof-432372 ' value='1673069'   \/><label for='answer-id-1673069' id='answer-label-1673069' class=' answer'><span>Submitting progress reports to the reviewing IRB\/IEC<\/span><\/label><\/div><!-- end question-choices--><\/div><!-- end questionWrap--><\/div><\/div><div style='display:none' id='question-46'>\n\t<div class='question-content'>\n\t\t<img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.dumpsbase.com\/freedumps\/wp-content\/plugins\/watupro\/img\/loading.gif\" width=\"16\" height=\"16\" alt=\"Loading...\" title=\"Loading...\" \/>&nbsp;Loading...\t<\/div>\n<\/div>\n\n<br \/>\n\t\n\t\t\t<div class=\"watupro_buttons flex \" 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