{"id":29130,"date":"2024-01-02T18:22:32","date_gmt":"2024-01-03T02:22:32","guid":{"rendered":"https:\/\/www.iths.org\/ctms\/?p=29130"},"modified":"2024-01-02T18:27:23","modified_gmt":"2024-01-03T02:27:23","slug":"updates-to-required-protocol-staff-assignments","status":"publish","type":"post","link":"https:\/\/www.iths.org\/ctms\/news\/updates-to-required-protocol-staff-assignments\/","title":{"rendered":"Updates to Required Protocol Staff Assignments"},"content":{"rendered":"<div>\n<p>As of <strong>January 1, 2024<\/strong>, two new Protocol Staff roles are required as <a title=\"https:\/\/urldefense.com\/v3\/__https:\/\/iths.cmail20.com\/t\/i-l-adlduut-thvulxth-u\/__;!!GuAItXPztq0!nES5_AxZocO1s8kR30J2HRP72CPN0puNbiOEsgMKnoj3-m6gANDE2CryW9fDrp7BQmK4B47JhbV0cd7ZRmBNNdXehO03OQ$\" href=\"https:\/\/urldefense.com\/v3\/__https:\/\/iths.cmail20.com\/t\/i-l-adlduut-thvulxth-u\/__;!!GuAItXPztq0!nES5_AxZocO1s8kR30J2HRP72CPN0puNbiOEsgMKnoj3-m6gANDE2CryW9fDrp7BQmK4B47JhbV0cd7ZRmBNNdXehO03OQ$\" data-emb-iscopy=\"true\">Minimum Footprint Guidelines<\/a> for OnCore Data Entry: <strong>Primary Regulatory Coordinator<\/strong> and <strong>Consenting Provider<\/strong>.<\/p>\n<p>Please see the information below regarding role descriptions, scope and location of entry in OnCore CTMS.<\/p>\n<h3><strong>Primary Regulatory Coordinator<\/strong><\/h3>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li><strong>Role Description<\/strong>: Primary protocol staff member responsible for regulatory documentation and IRB submissions<\/li>\n<li><strong>Scope: <\/strong>All protocols with a &#8216;New&#8217; status on or after 01\/01\/2024<\/li>\n<li><strong>Location in OnCore<\/strong>: PC Console &gt; Main &gt; Staff tab<\/li>\n<li><strong>Other Notes: <\/strong>\n<ul>\n<li>If there is only one protocol staff member managing regulatory submissions, assign them to the role of &#8216;Primary Regulatory Coordinator&#8217;<\/li>\n<li>Additional staff members\u00a0may be assigned the role of &#8216;Regulatory Coordinator&#8217;<\/li>\n<li>Protocols active in OnCore prior to 01\/01\/24\u00a0are not required to add the Primary Regulatory Coordinator role, but are encouraged to do so during regulatory staff transitions.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3><strong>Consenting Provider<\/strong><\/h3>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li><strong>Role Description<\/strong>: Provider\u00a0who facilitated the consent process and\/or signed the informed consent form<\/li>\n<li><strong>Scope<\/strong>: Oncology protocols categorized as DT4 = Interventional (<em>PC Console &gt; Main &gt; Details tab<\/em>) and for subjects consented on or after 01\/01\/2024<\/li>\n<li><strong>Location in OnCore<\/strong>: CRA Console &gt; Subject Console &gt; On Study tab, in the Subject Staff section<\/li>\n<li><strong>Other Notes<\/strong>:\n<ul>\n<li>Consenting Provider must be entered when Consented Status is documented in OnCore<\/li>\n<li>Staff member performing data entry must have Subject Management edit permissions in OnCore.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<\/div>\n<div>\n<div>\n<p>For questions regarding requirements and maintenance of Protocol Staff, please refer to the <a title=\"https:\/\/urldefense.com\/v3\/__https:\/\/iths.cmail20.com\/t\/i-l-adlduut-thvulxth-u\/__;!!GuAItXPztq0!nES5_AxZocO1s8kR30J2HRP72CPN0puNbiOEsgMKnoj3-m6gANDE2CryW9fDrp7BQmK4B47JhbV0cd7ZRmBNNdXehO03OQ$\" href=\"https:\/\/urldefense.com\/v3\/__https:\/\/iths.cmail20.com\/t\/i-l-adlduut-thvulxth-u\/__;!!GuAItXPztq0!nES5_AxZocO1s8kR30J2HRP72CPN0puNbiOEsgMKnoj3-m6gANDE2CryW9fDrp7BQmK4B47JhbV0cd7ZRmBNNdXehO03OQ$\" data-emb-iscopy=\"true\">Minimum Footprint Guidelines<\/a>, <a href=\"http:\/\/chrome-extension:\/\/efaidnbmnnnibpcajpcglclefindmkaj\/https:\/\/www.seattlectms.org\/CTMSWebApp\/static\/ctmsdocuments\/protocol_management\/protocol_management_work_instructions.pdf\">Protocol Management Work Instructions<\/a>, or contact <a title=\"mailto:ctms@fredhutch.org\" href=\"mailto:ctms@fredhutch.org\" data-emb-iscopy=\"true\">CTMS@fredhutch.org<\/a>. Please note that OnCore login is required to view documentation.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>As of January 1, 2024, two new Protocol Staff roles are required as Minimum Footprint Guidelines for OnCore Data Entry: Primary Regulatory Coordinator and Consenting Provider. Please see the information below regarding role descriptions, scope and location of entry in OnCore CTMS. Primary Regulatory Coordinator&#8230;<\/p>\n","protected":false},"author":8338,"featured_media":28881,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-29130","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/posts\/29130","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/users\/8338"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/comments?post=29130"}],"version-history":[{"count":5,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/posts\/29130\/revisions"}],"predecessor-version":[{"id":29135,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/posts\/29130\/revisions\/29135"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/media\/28881"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/media?parent=29130"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/categories?post=29130"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/tags?post=29130"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}