Protocol Details Overview

 

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:

Protocol Header

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.

E-mail

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.

Initial Review

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. 

Continuing Reviews

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. 

Amendments

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. 

Adverse Events

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. 

 

Other Events

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.