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The QM coordinator is also likely to be the author of the QM Summary Report.  If this is not the case, include the name and signature of the report author in the set of signatories.}\nTable of Contents\n{This uses the Table of Contents function in Microsoft Word that will automatically update headings and page numbers used in the body of the report.  In the body of the report, add, delete, or modify headings as needed. In order to ensure proper updating of the TOC, use the heading styles that are defined in the document: CROMS_Heading 1-CROMS_Heading 9.\nTo regenerate the Table of Contents and other links and cross-references in the document, Choose “Select all” and then F9.}\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc233817148\" \u00141\tStaff Participation in QM Reviews\t\u0013 PAGEREF _Toc233817148 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817149\" \u00142\tParticipant Data Review\t\u0013 PAGEREF _Toc233817149 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817150\" \u00142.1\tSummary of Review Process\t\u0013 PAGEREF _Toc233817150 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817151\" \u00142.2\tResults of Review:  General Issues, Trend Analysis, Corrective Actions\t\u0013 PAGEREF _Toc233817151 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817152\" \u00143\tStudy-wide Review\t\u0013 PAGEREF _Toc233817152 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817153\" \u00143.1\tEssential Documents Review\t\u0013 PAGEREF _Toc233817153 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817154\" \u00143.1.1\tSummary of Review Process\t\u0013 PAGEREF _Toc233817154 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817155\" \u00143.1.2\tResults of Review:  General Issues, Trend Analysis, Corrective Action\t\u0013 PAGEREF _Toc233817155 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817156\" \u00143.2\tLaboratory Specimens\t\u0013 PAGEREF _Toc233817156 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817157\" \u00143.2.1\tSummary of Review Process\t\u0013 PAGEREF _Toc233817157 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817158\" \u00143.2.2\tResults of Review:  General Issues, Trend Analysis, Corrective Action\t\u0013 PAGEREF _Toc233817158 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817159\" \u00143.3\tEquipment Set-Up and Calibration\t\u0013 PAGEREF _Toc233817159 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817160\" \u00143.3.1\tSummary of Review Process\t\u0013 PAGEREF _Toc233817160 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817161\" \u00143.3.2\tResults of Review:  General Issues, Trend Analysis, Corrective Action\t\u0013 PAGEREF _Toc233817161 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817162\" \u00143.4\tInvestigational Product/Device\t\u0013 PAGEREF _Toc233817162 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817163\" \u00143.4.1\tSummary of Review Process\t\u0013 PAGEREF _Toc233817163 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817164\" \u00143.4.2\tResults of Review:  General Issues, Trend Analysis, Corrective Action\t\u0013 PAGEREF _Toc233817164 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817165\" \u00143.5\tOther Study-wide Processes and Materials\t\u0013 PAGEREF _Toc233817165 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817166\" \u00143.5.1\tSummary of Review Process\t\u0013 PAGEREF _Toc233817166 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817167\" \u00143.5.2\tResults of Review:  General Issues, Trend Analysis, Corrective Action\t\u0013 PAGEREF _Toc233817167 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817168\" \u00144\tClinical site monitoring\t\u0013 PAGEREF _Toc233817168 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817169\" \u00144.1.1\tSummary of Clinical Site Monitoring\t\u0013 PAGEREF _Toc233817169 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817170\" \u00144.1.2\tSummary of Clinical Site Monitoring Findings\t\u0013 PAGEREF _Toc233817170 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817171\" \u00144.1.3\tClinical Site Monitoring Open Action Items\t\u0013 PAGEREF _Toc233817171 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817172\" \u00145\tOutstanding Items from Prior QM Reports\t\u0013 PAGEREF _Toc233817172 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817173\" \u00146\tQuality Management Plan Evaluation for Adequacy\t\u0013 PAGEREF _Toc233817173 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817174\" \u00147\tSummary and Conclusion\t\u0013 PAGEREF _Toc233817174 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc233817175\" \u0014Attachment 1:  Results ","cbCaidODzVtMYzRr","https://ap.wps.com/l/cbCaidODzVtMYzRr","docx",78538,"English","# Staff Participation in QM Reviews\n## Participant Data Review\n### Summary of Review Process\n### Results of Review: General Issues, Trend Analysis, Corrective Actions\n# Study-wide Review\n## Essential Documents Review\n## Laboratory Specimens\n## Equipment Set-Up and Calibration\n## Investigational Product/Device\n## Other Study-wide Processes and Materials\n# Clinical site monitoring\n## Summary of Clinical Site Monitoring\n# Outstanding Items from Prior QM Reports\n# Quality Management Plan Evaluation for Adequacy\n# Summary and Conclusion\n## Attachment 1: Results of Participant Data Review (Sample)\n## Attachment 2: Results of Essential Documents Review (Sample)\n## Attachment 3: Results of Other Study-wide Process and Materials Review (Sample)","[{\"question\":\"Who should be listed in staff participation for QM reviews?\",\"answer\":\"List each individual who participated in the quality management and review activities summarized in the report, including their title and which item(s) or categories they reviewed.\"},{\"question\":\"What should be included in the participant data review section?\",\"answer\":\"Include the total number of participants reviewed, a general description of review scope and completed quality management activities during the reporting period, aligned with the QMP.\"},{\"question\":\"How are review results and corrective actions described?\",\"answer\":\"Describe issues found, trends revealed, and the status or planned completion dates for corrective actions, including whether items require prompt reporting per the protocol.\"}]","Quality Management Summary Report - Table of Contents | DOCX",1788329549]