The Protocol Details page is accessed by clicking on the Title link from any of the Protocol tracking pages, with the exception of the Work in Progress page. The Protocol Details page shows the complete lifecycle of the protocol. The page will display any Continuing Reviews, Amendments, Adverse Events and Other Events associated with the protocol and the status of each submission. The grids can be fully expanded to show history by clicking the ‘+’ at either the top level, or on each individual record. The grids can be collapsed by clicking the ‘-’. The data reflected on the page is updated nightly from the Research Express (ReX) system.
The Protocol Details page has a header at the top with identifying protocol information and five grids capturing the following business processes:
Initial Review
Continuing Review
Amendments
Adverse Events
Other Events
The protocol header information is located at the top of the page. This includes general information about the protocol record.
For protocols that were created electronically using eIRB, below the breadcrumb trail bar is a button called ‘Current View’. This button will render a PDF document containing the most current approved forms questions and answers as well as any electronic attachments. Legacy protocols which were created manually and entered through Research Express do not have electronic versions of the application and therefore the ‘Current View’ button will not be displayed.
Header Elements
Column Name |
Description |
Protocol # |
A unique number assigned by Research Express for tracking the protocol. This number will remain throughout the entire lifecycle of the protocol. |
PI |
The name of the Principal Investigator assigned to the protocol (in the format Last Name, First Name). |
Title |
The title of the protocol. |
Version Name |
The sponsor protocol designation/number, i.e. acronym or cooperative-group protocol name/number. |
Sponsor |
The name of the sponsor. |
Overall Status |
The overall status of the protocol, including the project status. |
Approval Date |
The date the IRB approved the protocol. |
Expiration Date |
The date the protocol needs to be reviewed by in order to maintain an Active status. |
Administrator |
The Human Research Office (HRO) Administrator assigned to the protocol. |
|
The primary e-mail address of the HRO Administrator assigned to the protocol. |
Phone |
The phone number of the HRO Administrator assigned to the protocol. |
Responsible IRB |
The IRB to which the protocol was assigned to for review. |
Last Modified |
The date in which the protocol was last modified. |
There is only one Initial Review for a given protocol. The default view is the Initial Review collapsed to show only one row with the most current status visible. The entry can be expanded using the ‘+’ to show the complete lifecycle of the Initial Review. If there is a pending board, the pending line will appear. Once the Initial Review has been approved, the final approval line will appear.
Grid Elements
Column Name |
Description |
Date Received |
The date the initial submission was received. |
Board |
The name of the board assigned for review. |
Review Type |
The type of review that will be performed, i.e. Full or Expedited. |
Meeting Date |
The date the review took place or is scheduled to take place if it has not happened yet. |
Review Status |
The status of the review, i.e. Approved or Pending. |
Status Date |
The date the status of the protocol changed. For Full Board reviews this date will often be the same as the meeting date, but it might differ for Expedited reviews. |
Response Date |
The date a response to IRB questions was received from PI. |
Review Notes |
Displays any notes from the review as a WordPad file. Click on the notes icon to display the contents of the file. |
Workflow History |
Displays the workflow steps for the process including departmental and study staff sign-off. Click on the workflow icon to display the contents of the file. |
View |
Protocols created electronically will have a PDF icon in the “View” column. The PDF contains the questions and answers from the forms. |
Each Continuing Review (CR) has a row (or potentially several rows) in the grid. The default view displays each unique Continuing Review collapsed to show only one row with the most current status visible. The entry can be expanded using the ‘+’ to show the complete lifecycle of the Continuing Review. If there is a pending board, the pending line will appear. Once the Continuing Review has been approved, the final approval line will appear.
Grid Elements
Column Name |
Description |
CR # |
Unique identifier for this business process. |
Date Received |
The date the Continuing Review was received. |
Project Status |
The project status, i.e. enrolling subjects. |
Board |
The name of the board assigned for review. |
Review Type |
The type of review that will be performed, i.e. Full or Expedited. |
Meeting Date |
The date the review took place or is scheduled to take place if it has not happened yet. |
Review Status |
The status of the review, i.e. Approved or Pending. |
Status Date |
Date the status changed. For Full Board reviews this date will often be the same as the meeting date, but it might differ for Expedited reviews. |
Response Date |
The date a response to IRB questions was received from PI. |
Review Notes |
Displays any notes from the review as a WordPad file. Click on the notes icon to display the contents of the file. |
Workflow History |
Displays the workflow steps for the process including departmental and study staff sign-off. Click on the workflow icon to display the contents of the file. |
View |
Protocols created electronically will have a PDF icon in the “View” column. The PDF contains the questions and answers from the forms. |
Each Amendment (AME) has a row (or potentially several rows) in the grid. The default view displayed is each unique Amendment collapsed to show only one row with the most current status visible. The entry can be expanded using the ‘+’ to show the complete lifecycle of the Amendment. If there is a pending board, the pending line will appear. If there are multiple boards pending (IRB and Ancillary), then the pending IRB status will display. Once the Amendment has been approved, the final approval line will appear.
Grid Elements
Column Name |
Description |
AME # |
Unique identifier for this business process. |
Sponsor AME # |
Identifier assigned by the corporate sponsor. |
Date Received |
The date the Amendment was received. |
Board |
The name of the board assigned for review. |
Review Type |
The type of review that will be performed, i.e. Full or Expedited. |
Review Status |
The status of the review, i.e. Approved or Pending. |
Status Date |
Date the status changed. For Full Board reviews this date will often be the same as the meeting date, but it might differ for Expedited reviews. |
Response Date |
The date a response to IRB questions was received from PI. |
Review Notes |
Displays any notes from the review as a WordPad file. Click on the notes icon to display the contents of the file. |
Workflow History |
Displays the workflow steps for the process including departmental and study staff sign-off. Click on the workflow icon to display the contents of the file. |
View |
Protocols created electronically will have a PDF icon in the “View” column. The PDF contains the questions and answers from the forms. |
Each Adverse Event (AE) has a row (or potentially several rows) in the grid. The default view displayed is each unique Adverse Event collapsed to show only one row with the most current status visible. The entry can be expanded using the ‘+’ to show the complete lifecycle of the Adverse Event. If there is a pending board, the pending line will appear. Once the Adverse Event has been approved, the final approval line will appear. The entry can be expanded using the ‘+’ to show the complete lifecycle of the Adverse Event.
Grid Elements
Column Name |
Description |
Subject ID |
ID of the subject experiencing the Adverse Event. |
Date Received |
The date the Adverse Event was received. |
Board |
The name of the board assigned for review. |
Review Type |
The type of review that will be performed, i.e. Full or Expedited. |
Review Status |
The status of the review, i.e. Approved or Pending. |
Status Date |
Date the status changed. For Full Board reviews this date will often be the same as the meeting date, but it might differ for Expedited reviews. |
Response Date |
The date a response to IRB questions was received from PI. |
Review Notes |
Displays any notes from the review as a WordPad file. Click on the notes icon to display the contents of the file. |
Workflow History |
Displays the workflow steps for the process including departmental and study staff sign-off. Click on the workflow icon to display the contents of the file. |
View |
Protocols created electronically will have a PDF icon in the “View” column. The PDF contains the questions and answers from the forms. |
Each Other Event (OE) has a row (or potentially several rows) in the grid. The default view displayed is each unique Other Event collapsed to show only one row with the most current status visible. The entry can be expanded using the ‘+’ to show the complete lifecycle of the Other Event. If there is a pending board, the pending line will appear. Once the Other Event has been approved, the final approval line will appear.
Grid Elements
Column Name |
Description |
OE # |
Unique identifier for this business process. |
Event Type |
The type of Other Event, i.e. violation. |
Date Received |
The date the event was received. |
Board |
The name of the board assigned for review. |
Review Type |
The type of review that will be performed, i.e. Full or Expedited. |
Review Status |
The status of the review, i.e. Approved or Pending. |
Status Date |
Date the status changed. For Full Board reviews this date will often be the same as the meeting date, but it might differ for Expedited reviews. |
Response Date |
The date a response to IRB questions was received from PI. |
Review Notes |
Displays any notes from the review as a WordPad file. Click on the notes icon to display the contents of the file. |
Workflow History |
Displays the workflow steps for the process including departmental and study staff sign-off. Click on the workflow icon to display the contents of the file. |
View |
Protocols created electronically will have a PDF icon in the “View” column. The PDF contains the questions and answers from the forms. |