Several parties are involved in approving a protocol application. Principal Investigators must sign-off as being ultimately responsible for the study. Study staff will be responsible for reviewing the application, acknowledging participation, and certifying themselves as qualified to perform the study staff role. Individuals who are defined in the workflow process are assigned tasks and are responsible for completing these tasks and signing off when appropriate.
For all processes, workflow begins when the protocol application has been successfully validated and submitted through the Submission page. The culmination of workflow is official review by the IACUC. Depending on the type of protocol process (New Protocol Application, Amendment, Annual Review, Deficiency or Triennial Review) and the nature of the protocol, the workflow steps will differ. Below are the steps that have been defined in workflow. Each specific process has its own workflow configuration (See Appendix 1) that will include all or a limited number of the below steps.
Step 1: Principal Investigator Sign-off & Certification
Step 2: Submitter Review (optional)
Step 3: Subcommittee on Research Animal Care (SRAC) Review
Step 4: Study Staff Acceptance & Certification
Step 5: Ancillary Board Review
Step 6: IACUC Review & Approval
As a protocol moves through the submission and approval process, its status will change. The following table summarizes the various statuses and the tracking pages where the records will be displayed. This applies to all protocol processes including Initial Reviews, Annual Reviews, Amendments, Triennial Reviews and Deficiencies.
Protocol Status |
Description |
Insight Tracking Page |
In Progress |
The application is being created and is in a pre-submitted state. |
Work in Progress |
Submitted |
The application is awaiting sign-off by the Principal Investigator and for SRAC acceptance. The protocol or process has not yet moved to ReX. |
Pending Applications |
Pending |
The application has been signed off by the PI and SRAC office and has moved to ReX. It is now ready for study staff sign-off (if applicable), IACUC scheduling and board approval. |
Pending Applications |
Active |
All required boards have approved the application.
|
Active Protocols * Additional business processes will not have a distinct record on the Active Protocols page. The Protocol Details page of an Active protocol will display all processes that are associated with the protocol. |
A protocol application submitted using eIACUC consists of numerous forms that must be completed, study staff that need to be assigned, and documents that need to be attached. All of this occurs while the protocol is ‘In Progress’. The protocol must also be validated against all business rules to ensure a complete submission before routing for sign-off occurs. During this process, protocols will be displayed on the Work in Progress tracking page in Insight.
After the submitter successfully validates the application and hits the ‘Submit’ button on the Submission page, the protocol is routed to the Principal Investigator for sign-off. While these sign-offs are being obtained, the protocol status is ‘Submitted’. These applications will be displayed on the Pending Applications tracking page in Insight.
After the Principal Investigator has signed off, the protocol application moves to a status of ‘Pending’. During the ‘Pending’ state, the protocols are in the process of being reviewed by the SRAC office and will be scheduled for one or more board reviews for final approval. Pending applications are locked to prevent editing while under review. Applications will remain in a status of “Pending” until final board approval has occurred. These protocols will be displayed on the Pending Applications tracking page in Insight.
After all required boards have approved the application, the protocol will be set to ‘Active’ status. At this point the protocol is approved and has completed the workflow process. The protocols will be displayed on the Active Protocols tracking page in Insight.
The details of the workflow can be found by clicking on the Workflow icon on the Pending Applications page. The workflow displays the name of the submitter and all of the workflow steps including the main system and user actions such as PI sign off and subsequent sign-off steps.