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. 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.  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 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 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 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.

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 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 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, 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 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 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 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 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. 

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.

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.

The smartform application allows users to save their work before exiting the application. Users should periodically save their completed work in the smartform application in order to avoid losing any work due to the potential for timing out of the system or when the user needs to complete the application at a later time.  

In ARROW, the IRB review process is divided into different parts, called States. The State an application is in will change as it moves through the review process. The list of actions a user can take for a submission will vary according to the state it is in.

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. 

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 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 both a potential motion that can be made by the IRB upon review of a reportable event, as well as a state in ARROW.  Studies that are in the terminated state can be forwarded to the end state, Archive, by the IRB submission manager or will be automatically archived after 18 months. 

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.