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 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 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.

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 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.

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.

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 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 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.

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 reportable event. 

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 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.

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 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.