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.   


Certified

This is a state in ARROW.  Applications in this state have been certified as not constituting human subjects research.  This includes grant related applications not directly involving human subjects (e.g. protocol development activities only). 


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.


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. 


Closed

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. 


Consultant Review

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.


Continue Button

ARROW forms have a Continue button at the bottom that moves you forward through the application. Clicking Continue saves the current page and moves  the user to the next page. Continue is not the same as the Forward  button on a browser. Do not use the Forward button on a browser when completing forms in ARROW or the data entered will be lost.


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.


Correspondence Prepared

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.


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. 


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.  


Exit

An Exit link appears at the top of all ARROW application. Clicking this link exits the application, not the ARROW system. Always click Save before clicking Exit to make sure data is not lost.


Extend Exemption

This is an activity in ARROW that allows the study team to automatically set a new 5 year renewal period for the exemption if the activities are not yet complete.  The study team must provide attestation of exempt status of study.  There is no limited on the use of the “Extend Exemption” activity, as long as the activities conducted under the exemption are not yet complete and the the exempt status of the study has not changed.


Forward to Archive

This is an activity in ARROW that allows the IRB to move a study to the archived state. 


Hide/Show Errors

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.


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.


In Exempt Review

This is a state in ARROW.  Studies in this state have been identified as qualifying for exemption review and have been assigned an exempt reviewer.


In Expedited Review

This is state in ARROW.  Studies in this state have been identified as qualifying for expedited review and have been assigned an expedited reviewer. 


Inbox

The Inbox appears whenever a user logs into ARROW. Studies that appear in the Inbox require action by the user before a study can move forward in the review process.


IRB Administrative Review

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. 


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.


IRB Member Modification Review

This is a state in ARROW in which an IRB member can conduct a review of a modification response by the study team upon the request of an IRB staff reviewer.  In this state, the IRB member can submit modification review notes regarding their assessment of the modification response.  Then the IRB staff reviewer forwards the submission back to IRB Review of Modification Response.


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.


IRB Pre-Review

This is a state in ARROW.  Studies in this state will undergo pre-review by an assigned IRB staff reviewer.  The staff reviewer can perform multiple activities in this state, including sending the application for consultant review, sending the application to ancillary committee, completing pre-review checklist, and scheduling the application for an IRB meeting.


IRB Review of Modification Response

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.


IRB Withdrawn

This is a state in ARROW.  Studies in this state have been withdrawn by the IRB due to lack of response to an IRB request for modifications or deferral response.


Jump-To

The Jump-To menu at the top of each application allows the user to jump directly to any section of that form.


Modfications Requested

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.


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.


New Reportable Event

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


Point of Contact (POC)

The point of contact on a study has the capacity to edit the application and can also submit to the IRB on behalf of the PI.  There may four point of contacts assigned to a study and only the PI and the POCs can submit directly to the IRB.


Pre-Submission

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.


Reportable Events

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.


Resolved

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

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.


Roles

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.


Save

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.  


Scientific Review

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.


Send to Pre-Submission

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.


States

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.


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

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.  


Submit Administrative Hold Response

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.  


Submit Changes

This is an activity in ARROW that allows the PI or POC to submit changes requested by the scientific review committee.


Submit Deferral 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.


Submit Issues Response

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.


Submit Modification Response

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.


Submit Modification Review Notes

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


Submit Request to Reactivate

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.  


Submit Request to Reopen

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.


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.


Suspended

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.   


Terminated

This is both a potential motion that can be made by the IRB upon review of a reportable event, as well as a state in ARROW.  Studies that are in the terminated state can be forwarded to the end state, Archive, by the IRB submission manager or will be automatically archived after 18 months. 


View Differences

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.


Withdraw

This is an activity in ARROW that allows the PI or POC to withdraw a submission from the initial review process.  This activity moves the submission to the Withdrawn state at which time the PI or POC can make a copy of the application, send it back to Pre-Submission or archive it.


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.


Withdraw Reportable Event

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.


Withdrawn

This is a state in ARROW.  Submissions in this state have been withdrawn by the PI or POC.  Submissions in this state can be sent back to Pre-Submission or Archived by the PI or POC.