online solution: Clinical trial research Site Initiation Visit (SIV) case sce

Clinical trial research Site Initiation Visit (SIV) case scenario questions1. You travel across the country to conduct a SIV (Site Initiation Visit) at a new study site. You are   informed that the lead study coordinator has been out sick for 2 days and won’t be able to participate in the visit.1.  Why is this problem? 2.  What do you do?2. During a site initiation visit in Miami, Florida you realize that 60% of a site’s patient population is Spanish speaking.The Informed Consent Form is available in English only.1.  Why is this problem? 2.  What do you do?3. During a site initiation visit, you visit the site’s pharmacy. You inform the staff that the study drug is scheduled to be delivered the next day. You ask to see where the drug will be refrigerated.The pharmacy tech looks confused and says he didn’t realize the drug required refrigeration. He explains that the pharmacy does not have a refrigerator because the site doesn’t normally dispense drugs that need to be refrigerated.1.  Why is this problem? 2.  What do you do?4. During a SIV (Site Initiation Visit), you review the site’s essential documents and realize the recruitment flyers do not have an IRB approval stamp like the other study materials.  It seems this document was accidently left out of the IRB submission package.1.  Why is this problem? 2.  What do you do?5. During a “dry-run” at an SIV, the study coordinator enrolls you into a study, even though you play the role of someone who does not meet the inclusion/exclusion criteria.1.  Why is this problem? 2.  What do you do?  Health Science Science NursingBIO CTR130

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