Welcome to the Cal Poly Pomona e-IRB Guide
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 The purpose of this guide is to help investigators understand how to
navigate and complete a protocol using the e-IRB system.
Version 3/25/15.
Table of Contents
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Before you Begin
Registering as a “New eIRB User” and Logging on
eIRB Main Screen
Files and Documents
Protocol Form
Creating a New Protocol
Naming investigators
Attaching Supporting Protocol Documents
Protocol Form Checklist
Signing a Protocol
Submitting a Protocol
Protocol Status Change
Revising a Protocol
Check-in | Check-Out Protocol
 Viewing and Responding to Comments
 Approved Protocol
 Thank you
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Before you Begin…
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Browser Advice:
• The e-IRB system is maximized for Internet Explorer.
• While other browsers (Safari, Chrome, Firefox) do work, users may
experience errors while navigating through the e-IRB system.
• Popup blockers will interfere with the functionality of the
e-IRB system. If this does occur, make sure to set the pop-up
blocker to “Always Allow Pop-Ups from this site.”
 If you are a Mac user of IPAD user, please visit the FAQ section on our
website for instructions on how to allow pop-ups.
Remember to…
 Review regulations, policies, procedures, etc. - Review the other pages of the
IRB website for information and details regarding the essence of the human study
protocol process.
 Complete CITI training- All people involved in conducting the research
(investigator, advisor, and co-investigators) are required to complete CITI training for
approval of your IRB protocol. Visit the CITI web page for coursework on aspects of
research with human volunteers. Go to the section on "Continuing Education and
Training" for instructions and details as well as other training opportunities.
Registering as a “New eIRB User“ and Logging on
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Users of the e-IRB system are parties interested in
conducting human research through the Cal Poly Pomona
IRB. This includes both affiliated and unaffiliated
investigators.
Returning User
Log on by using the
username and
password previously
provided to you by the
IRB administrators.
This should be the
same as your Bronco
username and
password.
First Time User
First time investigators
desiring to access the eIRB system must first
have an account created
for them by the IRB
administrators.
To request an account
send an email to
irb@csupomona.edu,
more details about this
process will be on the next
slide.
Registering as a New eIRB User (cont.)
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When sending an email to the IRB administrator be sure to use the following format to expedite your request:
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First and last name
Highest degree attained (PhD, MS, BS, associates, etc., as appropriate)
Bronco ID (the nine digit number, which will eventually be used to link with CITI training data)
Bronco email (CPP email, e.g., billybronco@cpp.edu; Gmail and others don't work in the system)
Status (faculty, staff, student, unaffiliated, etc., as appropriate)
College and Department
Phone number
How to Log-In
Click on the following link:
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https://compliance.cpp.edu/tickatlab/default.aspx
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Your username and password will be the same as your bronco direct username and password.
e-IRB Main Menu Screen
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 This is the Main Menu screen and start screen for all users. The main menu provides a path to files
and documents (protocols).
 Think of the “File” being a folder in which you will store your documents. Likewise, think of the
“Documents” as being your protocol and any other attachments such as, consent forms, permissions,
survey print-out, etc.
Left clicking
on Files &
Documents
will give you
access to
enter
protocol
listing
screen.
Files & Documents
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This is the Files & Documents screen. Here users can create a new
protocol and gain access to edit existing protocols. Some other pertinent
functions in this menu include:
 Locating protocols and electronically sign.
 Close or withdraw protocols.
 Check in and check out protocols (see Check in | Check out slides).
Protocol Form
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This is a screen of the actual protocol. Here users will be able complete/edit their protocol application. Note the
protocol number will always be displayed in the top left corner (circled) e.g. in this case 14-0033 (protocol #) 1.0 (1st version).
Protocol number and version.
Back button will exit the
current protocol, returning
users back to the
protocol listing (Files &
Documents) page. To
navigate back within a
protocol use the
section tabs.
Left Click on sections
tabs to navigate through
protocol
Left Click on Action
for saving and
printing options.
It is strongly
advised that you
save your progress
at each session tab
before proceeding
to the next section.
!
Creating a New Protocol: Main Menu
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Left click to
proceed to Files
& Documents
(this will allow
you to
create/edit/view
to edit your
protocols.
Creating a New Protocol Through the
e-IRB System
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1. From the main protocol screen, click on
“NEW.”
2. This window will pop-up. Enter the title of
your protocol in the purple textbox, then click
“save and open document.”
Filling out the Protocol on the e-IRB System
1.Tabs
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2. Protocol Title & Other Information
Then, enter the
protocol’s title once
again..
Navigate to each
section tab, and fill
out the all sections.
First, select
“Title/General”
tab.
Entering the Investigators’ Names
Step 1 – Click on the left
tab titled “Personnel”
on the protocol form.
Step 2 – Once you open your protocol, your name is
automatically entered as the PI (Primary Investigator).
This can be edited by you during protocol revision, but not
while the protocol is under review. It can be changed by
the IRB office at anytime – contact at irb@cpp.edu.
Entering the Investigators’ Names
(Cont.)
Step 3 – Your name also automatically drops to
the “e- sign” portion of the page.
Step 4 – The PI is responsible for naming the co-PI’s on
the protocol. Remember, faculty advisors are considered
co-PI’s. To enter names, click “Edit selection.”
Entering the Investigators’ Names
(Cont.)
Step 5 – This window should pop up. Here, select the coPI’s names by using the filter or clicking on the “Colleges/
Groups” dropdown menu.
Step 6 – Select the name, then click “Apply current
selection” to add this person as a co-PI.
Entering the Investigators’ Names
(Cont.)
Step 7 – After you click “apply current selection”, close the
pop-up window. On your protocol main page, the name
you selected shows up here under “Other Investigators.”
Step 8: Repeat steps 5, 6 and 7 for the
“e-signing” section on the main protocol
page. PI and co-PI will be named here.
Entering the Investigators’ Names
(Cont.)
Step 9- After you have repeated steps 5-7, the
main protocol page will list both the co-PI and PI
under the “For e-signing” section.
Step 10 – Make sure to click “save” before
navigating away from the personnel page and
continue doing this through any tab you select.
Filling out the Protocol on the e-IRB System (Cont.)
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Navigate through
each tab and
complete each
entry by
responding to all
the questions in
each tab,
excluding
Workflow
History and IRB
Protocol Review
(IRB use only)..
*If the text boxes appear
to be grey and you are
unable to enter your
response, you must first
checkout the document
(see slide 33).
Attaching Supporting Protocol Documents
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1. Go back to the main
menu screen and right click
on the protocol’s title.
2. The attachments pop-up Window will appear. Select the
document you wish to attach, enter description of the document
and select “SAVE” before closing the window.
Protocol Form Checklist
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Prior to
submitting the
protocol use
the checklist
provided in the
section tab
Instructions /
Checklist, to
ensure your
protocol is
complete.
How to Electronically Sign your Protocol
on the eIRB
1.From the protocol form, go “
” to the main protocols
page and your protocol will be in “draft” form of the workflow.
2. Right click on the word “draft” under the blue bar. Then, left click on “Pre-review
and Sign” from the drop down menu.
3. After clicking on “Pre-review and sign,” this box will appear. You can send a
comment to the people who need to sign the protocol by entering the message in the
text box shown below.
*Make sure that the correct date is displayed in the text box otherwise, the protocol will not be available for
signing until the date that is selected.
4. Now, in the main menu page, your protocol’s status will be
“Pre-review and Sign.”
5. To enter your signature, right click on document status, then left
click on “e-Signatures.”
6.This pop-up window will appear. Please read the “Declaration By All
Investigators.” After doing so, enter your Bronco password in the text box. Here,
you may also see what other signatures are required.
7. After entering your Bronco password, your name will move down to “esignatures that have been provided” as you have signed your protocol.
Remember that there might be more signatures to provide, so make sure to
check the “Required signatures that are needed.”
8. After you close the signatures’ pop-up window, your
protocol will still be under “Pre-review and Sign” until
all the other co-PIs sign.
9. After the co-PIs have signed the protocol, you can refresh the page to see
that your protocol has now moved to “IRB office, Admin. Review.” IRBCO
means IRB compliance office, and at this point, the IRB administrative
review process will begin.
IRB Administrative Review Process
Admin. Review looks at:
1. Consent form.
2. Signatures.
3. CITI training.
4. Completion of protocol form.
5. Permission (if applicable).
Protocol Status Change Emails
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 The eIRB will automatically send email notifications to all the investigators involved in a
protocol, when its status has changed from:
“Draft” to “Pre-Review and Sign”- When protocol is ready to be signed by PI and co-PIs.
“Pre-Review and Sign” to “IRBCO Administrative Review”- After all required signatures have been submitted.
“IRB office, Admin. Review” to “For Revision (IRBCO)” - After the protocol has been reviewed by either the
administrative reviewer or the designated IRB
reviewer, and comments for the PI to address have
been posted.
“For Revision (IRBCO)” to “IRBCO Administrative Review” – After the PI has addressed all comments and revised the
protocol.
“IRBCO Administrative Review” to “Approved”- After the protocol has been approved and approval memo has been
generated.
How to Change the Protocol Status
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 Through the eIRB review process, the PI will ONLY be responsible for TWO protocol
status changes which are from:
“Draft” to “Pre-Review and Sign”-When protocol is ready to be signed by PI and co-PIs.
AND
“For Revision (IRBCO)” to “IRBCO Administrative Review”- After the PI has addressed comments made by the
reviewers and revised the protocol.
How to Change the Protocol Status (cont.)
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From the main menu, right click on the document’s title (under the
blue bar).
2. Select the appropriate protocol status change from the dropdown
menu.
1.
1.
2.
Check-in | Check-Out Protocol
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 Protocol Check-Out: A user checking out a protocol is analogous to checking out the sole copy of a library
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book, i.e. only one PI can have a protocol checked-out at a time.
Once a user has a protocol checked-out to them, they will be able to modify the content of the protocol.
It is important to note that only users with check-out privileges will be able to edit the protocol.
Alternatively, users may check-in the protocol so others users may modify it.
When a new protocol is created the author is automatically given check-out privileges to the protocol.
After selecting “Check-Out Document” the
protocol in the Files & Documents screen.
icon will display next to the
Check-in | Check-Out Protocol (Cont.)
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Protocol Check-In: Checking in a protocol allows for other users within the research team to edit the
document.
To check in a document, from the
Files & Document screen
right click on the protocol you
wish to edit to bring up more
options, then left click on
“Check-In Document”, this
will make the check-out icon
disappear.
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When a protocol is already checked out by another user the “already checked out” icon will appear. This
icon
lets users know that while the protocol is viewable it can not be edited by the current user until it
is checked in.
Check-In Reminder
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 Upon logging out of the e-IRB system, an automatic prompt will be generated
to remind users to check-in documents.
 Note that the IRB office doesn’t track research team’s check in-out statuses.
Therefore it is suggested, that research teams develop their own standard
operating procedures for checking in and out.
Revising a Protocol
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 Sometimes the first draft submitted for administrative review will need
to be revised by the PI. If this is the case, PI’s must use the Check-In
and Check-Out system to make the appropriate revisions.
Viewing and Responding to Comments
1. Click on the “Review”
option from the protocol
form.
2. This window will pop-up
and under each or some
tabs you will find comments
made by the admin
reviewer of designated IRB
reviewer (DIR).
3. To respond, simply click
on the comment and enter
your respond in the
“Response” box. To save
your response click
“Respond.”
Note: Make sure that you make the appropriate changes indicated by
the reviewer’s comments to your protocol in BOLD or Red.
Approved Protocol
1. Email Notification:
The investigators will receive an email
when their protocol has been e-signed by
the IRB chair and approved.
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2. Finding the Approval Memo on the E-IRB
Portal:
Right click on the
paper clip
. On
the drop down
menu select edit
attachment. Be
sure that the paper
clip you are
selecting is the file
not the document
(file is the pink bar).
This window will pop-up and
from here you can select the
file containing the approval
memo to be printed. The
header should say:
Thank you!
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 Thank you for your patience and hard work!
 Please share suggestions for improving this training guide.
 The eIRB looks formidable at first, but it will make sense. Some of its best features are:
-Automatic notices when your protocol is approaching expiration.
- Accessibility on mobile devices.
- Real-time updates about the protocol state.
Once again, Thank you!