{"id":2633,"date":"2016-07-10T22:16:10","date_gmt":"2016-07-11T02:16:10","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/irb\/?page_id=2633"},"modified":"2019-06-26T09:41:06","modified_gmt":"2019-06-26T13:41:06","slug":"monitoring-and-reporting","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/irb\/maintaining-irb-approval\/monitoring-and-reporting\/","title":{"rendered":"Monitoring and Reporting"},"content":{"rendered":"<p><strong><br style=\"clear: both;\" \/>Data Safety and Monitoring Plan\u00a0<\/strong><\/p>\n<ul>\n<li>No longer a separate template; instead, use the <a style=\"color: #0f69d7;\" href=\"\/irb\/files\/2016\/10\/Protocol-Template.docx\" target=\"_blank\" data-saferedirecturl=\"https:\/\/www.google.com\/url?hl=en&amp;q=https:\/\/www.bumc.bu.edu\/irb\/files\/2011\/03\/Protocol-Template.docx&amp;source=gmail&amp;ust=1478034517019000&amp;usg=AFQjCNGcDr5rDU_xsP5nI-r6JgpaCHd3cA\" rel=\"noopener\">Protocol Template<\/a><\/li>\n<\/ul>\n<p><strong>Corrective and Preventative Action (CAPA) Plan<\/strong><\/p>\n<ul>\n<li><a title=\"CAPA plan template\" href=\"\/irb\/files\/2017\/01\/CAPA-Template.doc\">Click here<\/a> for a CAPA plan template<\/li>\n<\/ul>\n<p><strong>Reporting table for Unanticipated Problems, Adverse Events, Serious Adverse Events, and Deviations<\/strong><\/p>\n<ul>\n<li><a title=\"Required reporting to the IRB\" href=\"\/irb\/files\/2019\/06\/Reporting_Requirements.pdf\" target=\"_blank\" rel=\"noopener\">Click here<\/a> for\u00a0a table showing required reporting to the IRB after initial approval.<\/li>\n<li>Note that if a different IRB is the IRB of record:\n<ul>\n<li>The reporting requirements of the IRB of record must be followed; AND<\/li>\n<li>Internal Study Personnel Changes and local Unanticipated Problems must also be reported to the BMC-BU Medical Campus IRB<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Flow Chart to determine Unanticipated Problems and Adverse Events<\/strong><\/p>\n<ul>\n<li><a title=\"Reporting Algorithm\" href=\"\/irb\/files\/2017\/01\/Reporting_Algorithm.pdf\" target=\"_blank\" rel=\"noopener\">Click here<\/a> for a copy of the reporting Algorithm or see below:<\/li>\n<\/ul>\n<p><img loading=\"lazy\" width=\"700\" height=\"525\" class=\"alignleft wp-image-2792\" alt=\"\" src=\"\/irb\/files\/2016\/08\/Algorithm-1.png\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Data Safety and Monitoring Plan\u00a0 No longer a separate template; instead, use the Protocol Template Corrective and Preventative Action (CAPA) Plan Click here for a CAPA plan template Reporting table for Unanticipated Problems, Adverse Events, Serious Adverse Events, and Deviations Click here for\u00a0a table showing required reporting to the IRB after initial approval. Note that [&hellip;]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":2629,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2633"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/users\/1250"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/comments?post=2633"}],"version-history":[{"count":21,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2633\/revisions"}],"predecessor-version":[{"id":3829,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2633\/revisions\/3829"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/pages\/2629"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/irb\/wp-json\/wp\/v2\/media?parent=2633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}