Health Sciences IRBs KnowledgeBase Health Sciences IRBs KnowledgeBase Glossary

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.

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.

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). 

This is a state in ARROW.  Studies in this state have been closed by the IRB after the investigator has submitted a study completion report. 

This is an activity in ARROW that allows the IRB staff reviewer to document nature of the consult and any relevant information about the outcome of the consult.

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.

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.

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.

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.

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.

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.

This is an activity available to study teams for all studies in the Approved state.  This allows study teams to initiate a reportable event. 

Refers to any submission that is not an initial, continuing or change of protocol.  Reportable events include noncompliance, new information, adverse events and unanticipated problems.

This is an end state in ARROW.  Reportable events in this state have been acknowledged by the IRB, but no further action is needed and therefore, the reportable event is considered resolved. 

Each user has at least one role assigned to them in ARROW. A user's current role appears in the gold box on the left side menu of the homepage. Some users will have multiple roles. Click the desired role under the My Roles text on the left side menu to change roles in the system. Be sure to select the correct role since different activities are available to users based on their role.

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. 

After a study has been approved with an administrative hold, study teams must resolve the conditions of this hold; this is done by submitting a 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.

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.

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.