Glossary search results: 84

Accept Facilitated Review

This is an activity in ARROW that allows the IRB staff reviewer to indicate that facilitated review is appropriate for the submission. This can include: accepting NCI Central IRB approval; deferring the study to a Commercial IRB (e.g. Western IRB) or deferral of the study to another institution's IRB.


Acknowledge Reportable Event

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.


Activity

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 Committee (ANC)

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.


Approve Expedited Application

This is an activity in ARROW that allows the IRB Staff Reviewer, IRB Director or IRB Member to approve a submission that is in the expedited approval state.  An activity form needs to be completed and then the state will switch to approved.


Approve Facilitated Application

This is an activity in ARROW that allows the IRB Staff Reviewer or IRB Director to approve a submission in the facilitated review state.  An activity form needs to be completed and then the state will switch to approved.


Approve Request to Reopen

This is an activity in ARROW that allows IRB Staff Reviewer to approve a request from the Study Team to reopen a closed study. 


Approved

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.


Approved with Administrative Hold

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). 


Archived

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. 


Assigned to IRB Meeting

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.


Awaiting Correspondence

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. 


Awaiting Scientific Review

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.   


Certified

This is a state in ARROW.  Applications in this state have been certified as not constituting human subjects research.  This includes grant related applications not directly involving human subjects (e.g. protocol development activities only). 


Certify Not Human Subjects Research

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.


Changes Requested - Scientific 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. 


Closed

This is a state in ARROW.  Studies in this state have been closed by the IRB after the investigator has submitted a study completion report. 


Consultant Review

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.


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Correspondence Prepared
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Hide/Show Errors
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