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.
This is a state in ARROW. Studies in this state must undergo review by the Institute for Clinical and Translational Research Scientific Review Committee (ICTR SRC), the UW Cancer Center Protocol Review and Monitoring Committee (PRMC) or the Clinical and Translational Research Core Protocol Implementation Review (CTRC PIR) before moving on to the IRB Pre-Review state.
Send to Pre-Submission
This is an activity in ARROW that allows the PI or POC to send an application back to the Pre-Submission state from the Withdrawn state.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an application from the IRB review process and now wants to start the submission process again using the previously withdrawn application.
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.
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.
Submit Administrative Hold Response
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.
Submit Deferral 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.
Submit Issues Response
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.
Submit Modification Response
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.
Submit Modification Review Notes
Review state to the IRB Review of Modification Response state once the assigned IRB member(s) has completed their review.
Submit Request to Reactivate
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.
Submit Request to Reopen
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.
Submit Study Completion Report
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.