Awaiting Scientific Review
This is a state in ARROW. Studies in this state have been triaged by the IRB and determined to require scientific review. In this state, the Scientific Review Committee (e.g. CTRC PIR, SRC, PRMC) will review the study and indicate the outcome of their review.
Certified
This is a state in ARROW. Applications in this state have been certified as not constituting human subjects research. This includes grant related applications not directly involving human subjects (e.g. protocol development activities only).
Certify Not Human Subjects Research
This is an activity in ARROW that allows the IRB staff reviewer to certify that an application does not constitute human subjects research. This activity occurs in the Pre-review state.
Changes Requested - Scientific Review
This is a state in ARROW. Studies in this state have undergone scientific review and changes were requested by the scientific review committee. In this state, the study team can either 1) respond to the committee request so that it returns to the Awaiting Scientific Review state for additional review, or 2) withdraw the application.
Forward to Archive
This is an activity in ARROW that allows the IRB to move a study to the archived state.
Hold for Scheduling: Ancillary Committee Review Pending
This is a state in ARROW. Studies in this state cannot be scheduled for an IRB meeting until the Ancillary Committee Review decision has been entered into the system.
Hold IRB Review - Submission of Reportable Event Pending
This is a state in ARROW. In this state, continuing and change applications are being held until a reportable event has been submitted by the study team. Once the reportable event has been submitted, the continuing or change will transition back to the pre-review state.
IRB Member Modification Review
This is a state in ARROW in which an IRB member can conduct a review of a modification response by the study team upon the request of an IRB staff reviewer. In this state, the IRB member can submit modification review notes regarding their assessment of the modification response. Then the IRB staff reviewer forwards the submission back to IRB Review of Modification Response.
IRB Review of Modification Response
This is a state in ARROW. Studies in this state were previously reviewed by the IRB and modifications were requested. The response from the study team requires review by the IRB to determine whether the study team has adequately addressed the IRB's requests. In this state, the IRB staff reviewer can send the modification response to an IRB member or schedule it for review at a full meeting.
Modfications Requested
This is a state in ARROW. Studies in this state have gone to an IRB meeting and IRB modifications have been sent to the study team. Study teams must submit a response to the modifications before the study can move on from this state.
New Full Change
This is an activity available to study teams for all studies in the Approved state. This allows study teams to initiate a new change of protocol.
Point of Contact (POC)
The point of contact on a study has the capacity to edit the application and can also submit to the IRB on behalf of the PI. There may four point of contacts assigned to a study and only the PI and the POCs can submit directly to the IRB.
Scientific Review
This is a state in ARROW. Studies in this state must undergo review by the Institute for Clinical and Translational Research Scientific Review Committee (ICTR SRC), the UW Cancer Center Protocol Review and Monitoring Committee (PRMC) or the Clinical and Translational Research Core Protocol Implementation Review (CTRC PIR) before moving on to the IRB Pre-Review state.
Submit Deferral Response
This is an activity in ARROW that allows the PI or POC to submit a deferral response to the IRB. Once the PI or POC submits the deferral response, the submission transitions back to the IRB Pre-Review state.
Submit Modification Response
This is an activity in ARROW that allows the PI or POC to submit their modification response to the IRB. Once the PI or POC submits their modification response, the submission transitions to the IRB Review of Modification Response state.
Submit Modification Review Notes
Review state to the IRB Review of Modification Response state once the assigned IRB member(s) has completed their review.
View Differences
This is an activity in ARROW that allows IRB staff, IRB members, and study teams to view differences between versions of the submitted smartform application. For example, if a study team made changes to the initial review application as a result of IRB Pre-Review and submitted those change to the IRB, a new version of the application is tracked. The study team and the IRB staff can easily view the differences between the old and new version of the application by using this activity button.