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 Annual Reviews, Triennial Reviews, Amendments, and Deficiencies 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 eIACUC, below the breadcrumb trail bar is a button called ‘Current View’.  This button will generate 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 clicking the ‘Current View’ button will display a message.  Legacy protocols will have a button called ‘Protocol Abstract’.  Clicking this button will pop up the text of the Protocol Abstract information previously entered in Rex.

 

 

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.

Sponsor

The name of the sponsor.

Overall Status

The overall status of the protocol, including the project status.

Approval Date

The date the IACUC 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.

Last Modified

The date in which the protocol was last modified.

Period Start Date

The protocol period start date.

Period End Date

The protocol period end date.

Species

The Animal species for this protocol

# Of Animals

The number of Animals approved for this protocol

Radioisotope

Yes for protocols that include Hazardous Materials – Radioisotopes

Biological Agent

Yes for protocols that include Hazardous Materials – Biological Agents

Toxic Chemicals

Yes for protocols that include Hazardous Materials – Toxic Chemicals or Carcinogens

Tissue Testing

Yes for protocols that include Tumor Production

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. Administrative, Designated or Full.

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.  This date will often be the same as the meeting date.

Response Date

The date a response to IACUC questions was received from PI.

Review Letters

Displays any notes from the Review as a PDF file.  Click on the PDF 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. 

Action

Click on Edit to Add / Remove Review Letters.  Click Save or Cancel to complete the action.

Annual Reviews

Each Annual Review (AR) has a row (or potentially several rows) in the grid.  The default view displays each unique Annual 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 Annual Review.  If there is a pending board, the pending line will appear.  Once the Annual Review has been approved, the final approval line will appear.

 

 

Grid Elements

Column Name

Description

AR #

Unique identifier for this business process.

Date Received

The date the Annual 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. Administrative, Designated or Full.

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.

Response Date

The date a response to IACUC questions was received from PI.

Review Letters

Displays any notes from the review as a PDF file.  Click on the PDF 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. 

Action

Click on Edit to Add / Remove Review Letters.  Click Save or Cancel to complete the action.

Triennial Reviews

Each Triennial Review (TR) has a row (or potentially several rows) in the grid.  The default view displays each unique Triennial 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 Triennial Review.  If there is a pending board, the pending line will appear.  Once the Triennial Review has been approved, the final approval line will appear.

 

 

Grid Elements

Column Name

Description

TR #

Unique identifier for this business process.

Date Received

The date the Triennial 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. Administrative, Designated or Full.

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.

Response Date

The date a response to IACUC questions was received from PI.

Review Letters

Displays any notes from the review as a PDF file.  Click on the PDF 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. 

Action

Click on Edit to Add / Remove Review Letters.  Click Save or Cancel to complete the action.

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 (IACUC and Ancillary), then the pending IACUC 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.

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. Administrative, Full or Designated.

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.

Response Date

The date a response to IACUC questions was received from PI.

Review Letters

Displays any notes from the review as a PDF file.  Click on the PDF 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. 

Action

Click on Edit to Add / Remove Review Letters.  Click Save or Cancel to complete the action.

Deficiencies

Each Deficiency (DF) will have a row (or potentially several rows) in the grid.  The default view will display each unique Deficiency collapsed to show only one row with the most current status visible.

 

Note - This functionality will be added in a future release.

 

 

Grid Elements

Column Name

Description

DF #

Unique identifier for this business process.

Deficiency Type

The type of Deficiency

Date Received

The date the Deficiency was received.

Board

The name of the board assigned for review.

Review Type

The type of review that will be performed, i.e. Administrative, Full or Designated.

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.

Response Date

The date a response to IACUC questions was received from PI.

Review Letters

Displays any notes from the review as a PDF file.  Click on the PDF 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. 

 

Action

Click on Edit to Add / Remove Review Letters.  Click Save or Cancel to complete the action.

 

 

 

 

 

Clone Protocol

The ‘clone protocol’ button is located at the bottom of the protocol details page and at the bottom of the Forms Page.  Refer to the Forms Page section to see a screenshot that includes the ‘clone protocol’ button.  This button allows the user to clone any protocols that were electronically created through eIACUC.  To clone a protocol, the user can optionally check the Include Staff and/or the Include Attachments box, then click ‘clone protocol’.  A title for the cloned protocol must be entered and upon saving that title, the cloned protocol will be placed within the user’s Work in Progress tab. Legacy protocols which were created manually and entered through Research Express do not have electronic versions of the application that could be cloned, and therefore the ‘clone protocol’ button will be disabled or ‘grayed out’ as in the example below.