Acknowledge Reportable Event
This is an activity in ARROW that allows the IRB staff reviewer to acknowledge receipt of a reportable event that does not require further IRB review. Upon acknowledgement, the study will return to the approved state.
Assigned to IRB Meeting
This is a state in ARROW. Studies in this state have been assigned to an upcoming meeting by either the IRB staff reviewer or the IRB submission manager. In this state, the IRB staff reviewer can record the IRB meeting decision and draft meeting minutes.
Awaiting Correspondence
This is a state in ARROW. Studies in this state have undergone IRB review, a meeting decision has been recorded and the IRB staff can draft correspondence for the study team.
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.
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.
Exemption Granted
This is a state in ARROW. Applications in this state have undergone review by an IRB staff reviewer and determined to qualify for exemption. In this state, the study team can submit changes of protocol, personnel changes, and reportable events, as well as report study completion.
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 - Continuing Review Required
This is a state in ARROW. In this state, change applications are being held until a continuing review application has been submitted by the study team and reviewed by the IRB.
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 Pre-Meeting
This is a state in ARROW. Studies in this state have been scheduled for an IRB meeting and go through the pre-meeting state in order to be scheduled for PRS or confirmed for an upcoming IRB agenda.
New Continuing Review (CR)
This is an activity available to study teams for all studies in the Approved state. This allows study teams to initiate a new continuing review application.
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.
Submit Changes
This is an activity in ARROW that allows the PI or POC to submit changes requested by the scientific review committee.
Withdraw Change
This is an activity in ARROW that allows the PI or POC to withdraw a submitted change from the review process. This activity moves the submission to the Withdrawn state at which time the PI or POC can send the submission back to Pre-Submission or archive it.
Withdraw Continuing Review
This is an activity in ARROW that allows the PI or POC to withdraw a submitted continuing review from the review process. This activity moves the submission to the Withdrawn state at which time the PI or POC can send the submission back to Pre-Submission or archive it.