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.
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.
Copy Reportable Event to Other Study
This is an activity in ARROW that allows the PI or POC to copy a reportable event application to another study. For example, if a reportable event affects several studies open by the PI, the PI only needs to fill out the RE application one time and then copy it to the other affected studies.
Deny Request to Reactivate
This is an activity in ARROW in which the IRB submission manager can deny a study team's request to reactivate a submission that was previously withdrawn by the IRB (e.g. due to lack of submission of a continuing review for a study that has an expired IRB approval). Execution of this activity will result in email notification to the study team that the request to reactivate has been denied and the study team will need to start the submission process over.
Deny Request to Reopen
This is an activity in ARROW in which the IRB submission manager can deny a study team's request to reopen a submission that was reported by the study team as completed or is in the closed 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.
IRB Close Study
This is an activity in ARROW that allows the IRB staff reviewer to close a study in the approved state once the study team has submitted a study completion report.
Study Completed
Once a study team has submitted a study completion report, the study moves from the "Approved" state to the "Study Completed" state. The study remains in this state for a period of 18 months, during which time the study team can reopen the study. After 18 months, the study is permanently archived.
Study Suspended
The IRB can suspend a study, automatically moving it to the "suspended" state rather than the "approved" state. Once a study has been suspended, activities available to the study team are limited. Study teams can initiate a change of protocol to address whatever caused the study to be suspended in the first place.
Study Team
The study team consists of the PI, the point of contact, and any other personnel listed as having edit/email or read-only access to study materials in the initial application smartform.
Submit Study Completion Report
This is an activity in ARROW that allows a PI or POC to submit their study completion report. This activity is available in the following states for an initial review: Approved, Exemption Granted, Expired. The study then transitions to the Study Completed state.