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.
Activity
An activity is an action that you can take for a submission. For example, if a study team wants to respond to pre-review issues, they would use the Send Issues Response activity. Activities are always listed on the left of each study workspace. The list of activities changes based on a user's role in ARROW and what state a submission is in.
Ancillary Committee (ANC)
Ancillary Committees (ANC) are committees that have oversight for specific areas of a submission, such as investigational drugs, conflict of interest, or Veterans Affairs (VA) issues. These committees do not issue approval for the study a whole; only for their areas of oversight.
The IRB will forward submissions to the appropriate ancillary committee if review is needed and has not yet been provided. Ancillary committees may request documentation from the study team that is additional to the IRB application completed in ARROW.
Approved
This is a state in ARROW. Studies in the Approved state have been reviewed and fully approved by the IRB and relevant ancillary committees, if any.
Approved with Administrative Hold
This is a state in ARROW. Studies in the Approved with Administrative Hold state have been reviewed and approved by the IRB; however, additional administrative documentation is required before final approval is granted (e.g. submission of a Certificate of Confidentiality).
Archived
This is a state in ARROW. Once an application is in the archived state, no other activities with that application are possible, other
than copy/paste of text. Studies in the archived state can not be re-opened.
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.