{"id":27290,"date":"2018-08-20T17:00:51","date_gmt":"2018-08-21T00:00:51","guid":{"rendered":"https:\/\/www.iths.org\/ctms\/?p=27290"},"modified":"2018-08-28T10:40:36","modified_gmt":"2018-08-28T17:40:36","slug":"important-process-changes-for-t1g2-study-teams","status":"publish","type":"post","link":"https:\/\/www.iths.org\/ctms\/news\/important-process-changes-for-t1g2-study-teams\/","title":{"rendered":"Important Go-Live Preparation Steps for T1G2 Study Teams"},"content":{"rendered":"

[vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_column_text]<\/p>\n

TARGET 1 GROUP 2 GOES LIVE ON MONDAY, SEPTEMBER 17, 2018<\/strong><\/h4>\n

In preparation for the go-live, some process changes will be in place as early as September 7. Study teams must familiarize themselves with the dates when mandatory changes will occur for study documentation and submission processes.[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][\/vc_column][\/vc_row][vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_column_text]<\/p>\n

\n\n\n\n\t\n\n\t\n\t\n\t\n\t\n\t\n\t
Date<\/th>Changes<\/th>\n<\/tr>\n<\/thead>\n
September 7<\/strong><\/td>For studies submitted to CRS:<\/em>
\nSTOP new study submissions; resume in OnCore and directly to FH\/CC-IRB on Sep 17
\nCRS will STOP issue of Consortium Protocol Numbers for T1G2
\n
\nFor studies submitted directly to FH\/CC-IRB:<\/em>
\nSTOP new study submissions; resume in OnCore and directly to FH\/CC-IRB on Sep 17
\n
\nFor studies with billing activity:<\/em>
\nCRBB will STOP issue of RG#s<\/td>\n<\/tr>\n
September 10<\/strong><\/td>Start submitting amendments, renewals and reportable events directly to IRB irbinbox@fredhutch.org<\/a><\/td>\n<\/tr>\n
September 10-14<\/strong><\/td>If an exception is needed to submit a study (e.g., includes expanded access, compassionate use), contact regulatoryaffairs@fredhutch.org<\/a> and iro@fredhutch.org<\/a><\/td>\n<\/tr>\n
September 12 (at 5 PM)<\/strong><\/td>Stop entering enrollment updates in PATS and Epic (as applicable)<\/td>\n<\/tr>\n
September 17 <\/strong><\/td>Resume enrollment updates in OnCore only
\nStart submitting new IRB applications directly to irbinbox@fredhutch.org<\/a><\/td>\n<\/tr>\n
Unchanged Processes:<\/strong>
\nContinue sRAMP submissions for any study that already has a Consortium Protocol Number
\nContinue submitting DSMC renewals via email to CRS<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

In preparation for the go-live, study teams should familiarize themselves with the dates when mandatory changes will occur for study documentation and submission processes including:\u00a0Study Submission to CRS, FH\/CC-IRB, CRBB Billing Activities, IRB Amendments, Renewals, & Events, Study Exceptions, and Enrollment Updates.<\/p>\n","protected":false},"author":1682,"featured_media":27304,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-27290","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\/27290","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\/1682"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/comments?post=27290"}],"version-history":[{"count":7,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/posts\/27290\/revisions"}],"predecessor-version":[{"id":27325,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/posts\/27290\/revisions\/27325"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/media\/27304"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/media?parent=27290"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/categories?post=27290"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iths.org\/ctms\/wp-json\/wp\/v2\/tags?post=27290"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}