Submit for Review

The Submit for Review action allows the investigators to submit protocols, amendments, renewals and response to revision requests to the IRB. The system allows for investigators to select the review type for the protocol, as well as the Category of research for Exempt and Expedited submissions.

Table 362 Protocol Document, Protocol Actions Page, Request an Action Section, Available Actions – Submit for Review – Action Attributes

  Action attributes

Description

Who can perform action

This action can be initiated by investigators.

Protocol state prior to action

Prior to the action being performed, the protocol must be in the following Status:

  • Pending/In Progress

  • Withdrawn

  • Provisionally Approved

  • Tabled

The Submission Status can be in any state.

Protocol state after action

After the action is performed:
The protocol Status changes to Submitted to IRB.

The Submission Status changes to Pending

 

 

 

Figure 719 Protocol Document, Protocol Actions Page, Request An Action Section, Available Actions – Submit for Review Layout

 

Table 363 Protocol Document, Protocol Actions Page, Request An Action Section, Available Actions – Submit for Review Field Descriptions

Field

Description

Submit for Review

Submission Type

The Submission Type will default to the appropriate type based on the type of submission you are creating:

  • Initial Protocol Application

  • Amendment

  • Renewal with Amendment

  • FYI

     

Type Qualifier

Only required for certain types of submissions. Use the drop-down

menu by clicking the down arrow to display the list, and then click on an item in the list to select it.

 

When Submission Type = FYI, one of the following options must be selected:

  • Audit Report

  • General Information

  • Noncompliance Report

  • Prompt Report – AE/UADE

  • Prompt Report – Change in FDA labeling

  • Prompt Report – Change to IRB-approved protocol

  • Prompt Report – Complaint

  • Prompt Report – Investigator- or Sponsor-initiated suspension or hold

  • Prompt Report – Major Protocol Deviation

  • Prompt Report – Other

  • Prompt Report – Publication in literature, safety monitoring report, interim result, or other finding

  • VA - Audit Report

  • VA - Noncompliance Report

  • VA - Prompt Report

When Protocol Type = Deferral and Submission Type = Initial Protocol Application, one of the following options must be selected:

  • IU Accepts Approval from another IRB

  • NCI

  • WIRB

When Protocol Type = Non Human Subjects Research and Submission Type = Initial Protocol Application, one of the following options must be selected:

  • Non-Human Subjects

  • Student Project

Submission Review Type

This field will default to the appropriate value based on the Protocol Type indicated on the Protocol tab.

Click to submit the review request.  Persons with designated protocol roles will receive the Action Request in their Action Lists.