Health Sciences IRBs KnowledgeBase Health Sciences IRBs KnowledgeBase Glossary

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 in which the IRB submission manager can deny a study team's request to reactivate a submission that was previously withdrawn by the IRB (e.g. due to lack of submission of a continuing review for a study that has an expired IRB approval).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

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 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.

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

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.

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.

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.

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 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.