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:
Initial Review
Annual Review
Triennial Review
Amendments
Deficiencies
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. |
|
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 |
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. |
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. |
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. |
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. |
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. |
| |
|
|
|
|
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.