{"id":6066,"date":"2023-02-24T12:49:31","date_gmt":"2023-02-24T17:49:31","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/crro\/?page_id=6066"},"modified":"2023-02-24T12:52:36","modified_gmt":"2023-02-24T17:52:36","slug":"resources-library","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/crro\/resources-library\/","title":{"rendered":"Resources Library"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The CRRO has a number of tools, templated documents, and guidance available for the research community to use. These resources are optional but are generally recommended to help teams meet protocol adherence and regulatory standards.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.bumc.bu.edu\/crro\/tools\/\"><span style=\"font-weight: 400;\">Study Documentation Tools<\/span><\/a><br \/>\n<span style=\"font-weight: 400;\">Documents in template form are available for managing participant-related and regulatory-related documentation as part of ICH GCP and general best practices. Further guidance on Study Documentation is also available in the <\/span><a href=\"https:\/\/www.bumc.bu.edu\/ohra\/required-training\/institutional-standard-operating-procedures-sops\/\"><span style=\"font-weight: 400;\">SOP specifically on Essential Research Documents<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.bumc.bu.edu\/crro\/resources-library\/self-assessment-tools\/\">Self-Assessment Review Tools<\/a><br \/>\n<\/span><span style=\"font-weight: 400;\">Checklists are available for teams to complete their own internal review on documentation and adherence. Those wishing for additional information are encouraged to to review the <\/span><a href=\"https:\/\/www.bumc.bu.edu\/ohra\/required-training\/institutional-standard-operating-procedures-sops\/\"><span style=\"font-weight: 400;\">SOP specifically on Quality Management<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.bumc.bu.edu\/crro\/research-professional-network\/resources-programs\/reference-guide\/\"><span style=\"font-weight: 400;\">Clinical Research Reference Guide<\/span><\/a><br \/>\n<span style=\"font-weight: 400;\">Developed by the <\/span><a href=\"https:\/\/www.bumc.bu.edu\/crro\/research-professional-network\/\"><span style=\"font-weight: 400;\">Research Professionals Network<\/span><\/a><span style=\"font-weight: 400;\">, this provides new and existing research team members with key information about research conducted at Boston University Medical Campus and Boston Medical Center.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.bumc.bu.edu\/ohra\/for-research-participants\/brochures-for-participating-in-research\/\"><span style=\"font-weight: 400;\">Brochures for Participating in Research<\/span><\/a><br \/>\n<span style=\"font-weight: 400;\">A set of brochures is available to provide to prospective and enrolled participants as well as community members and patients in general.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.bumc.bu.edu\/crro\/tools\/e-consent-tools-and-guidance\/\"><span style=\"font-weight: 400;\">eConsent<\/span><\/a><br \/>\n<span style=\"font-weight: 400;\">Study teams wishing to use electronic consents either for in-person or remote consenting are recommended to review this set of guidance. These documents include an overview providing general information and specific REDCap guidance on Exempt and Non-Exempt research. Regulatory-specific guidance on implementing eConsent is also available by requesting a <\/span><a href=\"https:\/\/www.bumc.bu.edu\/crro\/research-and-regulatory-consultations\/\"><span style=\"font-weight: 400;\">CRRO consultation<\/span><\/a><span style=\"font-weight: 400;\">. Additional REDCap guidance is available by <\/span><a href=\"mailto:rchelp@bu.edu\"><span style=\"font-weight: 400;\">requesting a REDCap consultation<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.bumc.bu.edu\/ohra\/required-training\/institutional-standard-operating-procedures-sops\/\"><span style=\"font-weight: 400;\">Institutional Standard Operating Procedures (SOPs)<\/span><\/a><br \/>\n<span style=\"font-weight: 400;\">Covering a wide range of topics, the SOPs include guidance on how to complete some of the daily activities of a research team and also address overarching structural activities. Additional information about SOPs are available monthly in the <\/span><a href=\"https:\/\/www.bu.edu\/crtimes\/\"><span style=\"font-weight: 400;\">Clinical Research Times newsletter<\/span><\/a><span style=\"font-weight: 400;\"> column titled \u201cSpotlight on SOPs\u201d.\u00a0<\/span><\/p>\n<hr \/>\n<p><i><span style=\"font-weight: 400;\">For training or guidance on how to use any of these documents, <\/span><\/i><a href=\"https:\/\/www.bumc.bu.edu\/crro\/research-and-regulatory-consultations\/\"><i><span style=\"font-weight: 400;\">complete the Request CRRO Services form<\/span><\/i><\/a><i><span style=\"font-weight: 400;\">.<br \/>\n<\/span><\/i><i><span style=\"font-weight: 400;\">Recommendations for additional resources that could be developed? <\/span><\/i><a href=\"mailto:crro@bu.edu\"><i><span style=\"font-weight: 400;\">Contact us!<\/span><\/i><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The CRRO has a number of tools, templated documents, and guidance available for the research community to use. These resources are optional but are generally recommended to help teams meet protocol adherence and regulatory standards.\u00a0 Study Documentation Tools Documents in template form are available for managing participant-related and regulatory-related documentation as part of ICH GCP [&hellip;]<\/p>\n","protected":false},"author":21213,"featured_media":0,"parent":0,"menu_order":18,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/6066"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/users\/21213"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/comments?post=6066"}],"version-history":[{"count":3,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/6066\/revisions"}],"predecessor-version":[{"id":6069,"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/pages\/6066\/revisions\/6069"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/crro\/wp-json\/wp\/v2\/media?parent=6066"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}