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 state have been reviewed and fully approved by the IRB and relevant ancillary committees, if any.

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 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 reopen a submission that was reported by the study team as completed or is in the closed state. 

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.  

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.

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, 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 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.

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

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

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. 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.

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. 

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 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.

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.