{"id":478,"date":"2016-09-23T16:03:11","date_gmt":"2016-09-23T20:03:11","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/ohra\/?page_id=478"},"modified":"2024-06-24T14:38:19","modified_gmt":"2024-06-24T18:38:19","slug":"quality-assurance-reviews-faqs","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/ohra\/audits-for-research-oversight\/quality-assurance-reviews-faqs\/","title":{"rendered":"FAQs \u2013 Quality Assurance Reviews"},"content":{"rendered":"

One of the primary activities of the Research Quality Program (RQP) is to conduct Quality Assurance (QA) reviews of selected IRB approved research studies. If you have received a notice informing you that your study has been chosen to undergo a QA review, the following FAQs will provide you with additional information about the process. Review <\/span>section 11.3 of the BMC\/BUMC HRPP policies and procedure<\/span><\/a>s for further details.<\/span>\u00a0<\/span><\/p>\n

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  1. Is this a for-cause\/targeted audit?<\/span>
    \n<\/span>No, a QA review is not a for-cause\/targeted audit and is not performed in response to a concern or complaint. Instead, QA reviews are routinely performed for any study that has been recently IRB-approved and meets the criteria for conducting a QA review. QA reviews are intended to provide a quick \u201csnapshot\u201d overview of the study\u2019s compliance with regulations, policies, and best practice guidance.<\/span><\/li>\n<\/ol>\n
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    1. Who will conduct the QA review?
      \n<\/span>QA reviews are conducted by Human Research Quality Managers from the Research Quality Program (RQP), under the BMC\/BU Medical Campus Office of Human Research Affairs (OHRA). While we are a part of BMC\/BUMC\u2019s research compliance, we are separate from the IRB.
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      1. Why was my study selected for a QA review? <\/span>
        \n<\/span>Your study was selected because it was recently approved by the BMC\/BUMC IRB. We try to identify studies shortly after IRB-approval once at least a few subjects have been enrolled so that any issues that need to be corrected are identified early in the conduct of the study. However, a study may undergo a QA review at any time during the study lifecycle.\u00a0 Any study can be chosen, but the emphasis is on those studies that meet one or more of the following characteristics:<\/span>\u00a0<\/span><\/li>\n<\/ol>\n