Changes to consent Submit as required Email tracked As required by Change-In-Protocol Submit as required tracked changes materials/recruitment by central unless changes for review NCI-CIRB Form and revised for review prior to by Reviewing IRB materials impacting sponsor submits on prior to central IRB; consents with External IRB; unless sponsor local language SLU’s behalf otherwise will review changes tracked and otherwise will review submits on SLU’s during/after Central copy during/after External behalf Continuing Reviews Site progress Email copy of As required by Continuing Review As required by Email copy of reports or other documents NCI-CIRB Form documents Reviewing IRB form as required by submitted to central submitted to central IRB Reviewing IRB Unanticipated Central IRB form as Email copy of As required by As required by Email copy of required by central documents NCI-CIRB documents Problem (Local UP Reviewing IRB that may or may not IRB. submitted to central Information form submitted to also be an SAE) IRB Reviewing IRB SAEs that are not UPs As required by Email according to As required by Email according to As required by Email according to central timelines described NCI-CIRB timelines described timelines described Reviewing IRB in . in . in . Central IRB form as Email copy of As required by As required by Email copy of Protocol violations that affect subject required by central documents NCI-CIRB documents Reviewing IRB rights/safety or data IRB. submitted to central Information form submitted to integrity; consenting IRB Reviewing IRB errors SLU Site Monitor As required by Email copy to As required by As required by Email copy to Reports central NCI-CIRB Reviewing IRB Information form DSMB Reports Typically submitted Nothing Required if As required by With continuing As required by Nothing Required if by Sponsor unless recommends NCI-CIRB review reports recommends Reviewing IRB using as local IRB continuance continuance
Changes to consent materials/recruitment materials impacting local language Submit as required by central unless sponsor submits on SLU’s behalf Email tracked changes for review prior to central IRB; otherwise will review during/after Central As required by NCI-CIRB Change-In-Protocol Form and revised consents with changes tracked and copy Submit as required by Reviewing IRB unless sponsor submits on SLU’s behalf tracked changes for review prior to External IRB; otherwise will review during/after External Continuing Reviews Site progress reports or other form as required by central Email copy of documents submitted to central IRB As required by NCI-CIRB Continuing Review Form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB Unanticipated Problem (Local UP that may or may not also be an SAE) Central IRB form as required by central IRB. Email copy of documents submitted to central IRB As required by NCI-CIRB Information form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB SAEs that are not UPs As required by central Email according to timelines described in . As required by NCI-CIRB Email according to timelines described in . As required by Reviewing IRB Email according to timelines described in . Protocol violations that affect subject rights/safety or data integrity; consenting errors Central IRB form as required by central IRB. Email copy of documents submitted to central IRB As required by NCI-CIRB Information form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB SLU Site Monitor Reports As required by central Email copy to As required by NCI-CIRB Information form As required by Reviewing IRB Email copy to DSMB Reports Typically submitted by Sponsor unless using as local IRB Nothing Required if recommends continuance As required by NCI-CIRB With continuing review reports As required by Reviewing IRB Nothing Required if recommends continuance
central_irb_post_approval_requirements.docx