Several parties are involved in approving a protocol application. Principal Investigators and Department Chairs 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 IRB. Depending on the type of protocol process (New Protocol Application, Amendment, Continuing Review, Adverse Event or Other Event) 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: Critical Sign-off & Certification
Step 2: Submitter Review (optional)
Step 3: Human Research Office (HRO) Review
Step 4: Study Staff Acceptance & Certification
Step 5: Ancillary Board Review
Step 6: IRB 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, Continuing Reviews, Amendments, Other Events and Adverse Events.
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 critical sign-off by Principal Investigators and Department Chairs (if applicable). |
Pending Applications |
Pending |
The application has been signed off by all critical parties and is now ready for study staff sign-off (if applicable), IRB 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 eIRB 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(s) and Department Chair(s) for sign-off. If a performance site of Newton Wellesley Hospital (NWH), Spaulding Rehabilitation Hospital (SRH) or North Shore Medical Center (NSMC) is included on the study, then the site IRB Chair is also required to 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 Principle Investigators (PI(s)) and Department and/or IRB Chair(s) have 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 Human Research 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.