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.

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 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.  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. 

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 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). 

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.

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.

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 that allows the IRB to move a study to the archived state. 

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 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 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.

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 an activity available to study teams for all studies in the Approved state.  This allows study teams to initiate a new continuing review application.

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.

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.

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.

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. 

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 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 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 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.

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.

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.