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.

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 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.  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 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 IRB to move a study to the archived 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, 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 a state in ARROW.  Studies in this state have been identified as qualifying for exemption review and have been assigned an exempt reviewer.

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

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 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 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.

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 been withdrawn by the IRB due to lack of response to an IRB request for modifications or deferral response.

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.

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

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.

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.

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 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 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.

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.

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.

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.