Health Sciences IRBs KnowledgeBase Health Sciences IRBs KnowledgeBase Glossary

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 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.

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. 

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.   

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.

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. 

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 an activity in ARROW that allows the IRB floater to confirm that correspondence they've drafted is ready for review by the IRB staff reviewer.

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in which the IRB submission manager can deny a study team's request to reactivate a submission that was previously withdrawn by the IRB (e.g. due to lack of submission of a continuing review for a study that has an expired IRB approval).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.

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. 

The Hide/Show Errors link appears at the top of each application form. This link checks the submission for any required questions that are not answered.

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, 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 a state in ARROW.  Studies in this state will undergo administrative review by the IRB submission manager in order to determine appropriate IRB and staff reviewer assignment.  In this state, the IRB submission manager can also send administrative issues to the study team. 

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 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.

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.

This is a state in ARROW. Pre-submission is the default state for any newly-created submission. Applications in Pre-Submission have not yet been submitted to the IRB.

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. 

Reviewer Notes are notes made in an application by IRB staff. Reviewer notes labeled IRB Question require a response from the study team. Only IRB staff can create Reviewer Notes in ARROW.

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.

The smartform application allows users to save their work before exiting the application. Users should periodically save their completed work in the smartform application in order to avoid losing any work due to the potential for timing out of the system or when the user needs to complete the application at a later time.  

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.

This is an activity in ARROW that allows the PI or POC to send an application back to the Pre-Submission state from the Withdrawn state. For example, the PI withdrew an application from the IRB review process and now wants to start the submission process again using the previously withdrawn application.

In ARROW, the IRB review process is divided into different parts, called States. The State an application is in will change as it moves through the review process. The list of actions a user can take for a submission will vary according to the state it is in.

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. 

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. 

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. 

This is an activity available to study teams, allowing them to submit an initial application, continuing review, change of protocol, reportable event, etc., to the IRB.  

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 changes requested by the scientific review committee.

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 the PI or POC to submit their response to issues sent by the IRB.  Once the PI or POC submits their response to issues, the submission transitions back to the IRB Pre-Review state.

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.

Review state to the IRB Review of Modification Response state once the assigned IRB member(s) has completed their review. 

This is an activity in ARROW that allows a PI or POC to submit a request to reactivate a submission that is in the IRB withdrawn state.  

This is an activity in ARROW that allows a PI or POC to submit a request to reopen a study that is in the Study Completed state or in the Closed 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 a state in ARROW.  Studies in this state have been suspended.  Research teams can only submit a change of protocol in this state.  Once the IRB approves the change of protocol addressing the issues which resulted in the suspension, the IRB will then review the full study to determine if the suspension can be lifted and the study can be moved back to the approved state.   

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.