Upcoming iRIS Office Hours
May 19, 2022 @ 3pm
Webinar ID: 917 4730 9194
Topics covered will include:
NEW Process for Alert Pages and Sponsor Correspondence
- Pharmacy & Nursing will create/modify alert pages themselves using an Alert Page Generator on OncPro. Alert Pages will no longer be attached to a submission in iRIS.
- Sponsor Correspondence that requires IRB review can be submitted separately using the Administrative Modification Form. It will route to the IRB who will then determine if it requires Nursing and Pharmacy Feasibility review and Feasibility will add it to the Alert Page if necessary. These will not route to ODQ Activation.
- A revised DFCI IRB policy on sponsor correspondence will define what information must be submitted for IRB review, and what information is appropriate to communicate using alert pages.
NEW Form ‘Addition of Secondary Study Team’ to submit and update Management Groups
- The Study Teams listed in iRIS interface to the Management and Oncology Groups in OnCore. The primary study team is captured on the NPA for the core site. However, there is a new Form in iRIS that can be used to update any additional study teams in OnCore. This change is a result of efforts to decrease emails to OHRS for OnCore Management Group changes.
NEW Process for External Approval for Scientific Review Committee (SRC) review
- OHRS will now accept scientific review and approval of a new protocol from another NCI-designated Comprehensive Cancer Center. Study teams may choose to submit documentation of external scientific review in iRIS with the New Protocol Application. While this is optional, providing the documentation avoids the need for a full, local scientific review.
- Continuing Review forms that would require IRB full board review based on the study classification and study status will be routed to the DF/HCC OHRS Pre-Review committee (formerly named the DF/HCC OHRS Consent Review committee) at the same time as the IRB. The OHRS pre-review will address any form corrections and training requirements prior to the IRB meeting.
- This does not change the timeline for continuing review submission or IRB approval.