University Safety and Assurances

Web Submissions Through IRBManager

IRBManager is a fully web based system allowing users with an internet browser to securely: login and submit IRB submissions; send and receive automatic notices; view the status of active, closed, or recent submissions; and maintain the entire IRB file in one central place. 

Students or someone other than the main Principal Investigator will be allowed to complete and submit forms.  However, the PI will be required to log in, review the submission, and press the final submit button before the IRB can receive the study for review.

Access IRBManager



IMPORTANT:

There are two ways to log in to IRBManager:

1. UWM faculty, staff and students may now log in using their UWM ePanther ID user name and password throughout IRBManager by selecting the 1Login link in the center of the IRBManager login page.  (Alternatively, UWM faculty, staff and students may also continue to use the independent IRBManager user name and password by clicking on the login link at the bottom of the box.)


2. Non UWM Personnel (without an ePanther ID), may request an IRBManager account through the UWM IRB Office using the link below.  These users will have a user name and password specific to IRBManager.


 
 CLICK HERE TO ACCESS:  IRBManager_Logo

 

Register for a New IRBManager Account



To request an IRBManager account:

  • UWM faculty, staff, or students without an account may simply log into IRBManager by selecting the 1Login link in the center of the IRBManager login page and login with their UWM ePanther ID and password.  An account will automatically be created.

  • Non UWM personnel (without an ePanther ID) may request an IRBManager account to be set up by the UWM IRB office using the link that follows.  These users will have a user name and password specific to IRBManager.  Complete the following form to request an account.

Please note that accounts are generated by UWM IRB staff during regular business hours (Monday through Friday, 8am-4pm).

IRBManager Support and Questions


If you have have any questions regarding IRBManager, please contact the IRB Office at irbinfo@uwm.edu or 414-229-3173 or 414-229-3182.  We are generally available Monday through Friday between 8am and 4pm, and we will reply to voice or email messages as soon as possible.

 

User Guides and Training Information for IRBManager



The User Guide for Researchers includes general information about IRBManager and how to navigate through the system and create new submissions, amendments, continuing reviews, and amendments.

The IRBManager PowerPoint presentation is used for in person training, but may be very useful for people that need a basic understanding of the system without the hands on training.

 

Intro to the IRB/How to Submit a Study:  The IRB staff is also offering in-person "Introduction to the UWM IRB- How to submit a study" session where we go over how to prepare a submission, offer helpful hints and do hands on demonstrations of the online submission system, IRBManager.  These trainings will last one hour and be offered in ENGELMANN 242/248. 

September 12, 2014 at 2 pm

September 23, 2014 at 10 am

October 9, 2014 at 11 am

October 27, 2014 at 2 pm

November 12, 2014 at 10 am

December 9, 2014 at 1 pm

 

Registration required:  To register for a training session, please click here for a link which will bring you to a Qualtrics registration page.

Frequently Asked Questions

If you do not find the answer to your question here, feel free to contact the IRB at irbinfo@uwm.edu or 229-3173 or 229-3182.  If you would like to see the answers to these questions with screen shots please click here.

 

1. How do I obtain a user name and log in?

2.What if I forgot my password?

3.How do I change my password?

4.How do I update my user information?

5.How do I initiate a new study?

6.How do I submit an amendment, continuing review, or reportable event for a study that exists in IRBManager?

7.Can a student (or coordinator or other) complete xforms?

8.How does the PI sign off on a form submitted by a SPI or another?

9.How will I know the status of my submission?

10.I submitted a study, but cannot see it listed on my Home page.

11. How do I submit revisions that have been requested by the IRB?

12.How will I know when my study is approved?

13.How can I add other investigators, research assistants, etc. to my study?

14.I submitted my continuing review but I continue to receive reminders about the upcoming expiration.Do I need to do anything?

15. How do I find attachments for studies that have been approved or that are under review by the IRB?


16. Can I share an xForm with others during the writing/editing process so they can review and edit the xForm?

 

1.How do I obtain a user name and log in?

  1. UWM faculty, staff and students with an ePanther ID:
           a. log into IRBManager (https://uwm.my.irbmanager.com) using your ePanther ID and password by selecting the 1Login link in the center of the IRBManager login page.  An IRBManager account will automatically be created.
  2. Non-UWM personnel (without an ePanther ID)
    1. Complete the IRBManager log in and password request form on the IRB website.The IRB will email you your log in and a temporary password.
    2. Click on the IRBManager icon from the IRB website (IRBManager page) or go to: https://uwm.my.irbmanager.com
    3. Click on the login link at the bottom of the login box to use an IRBManager issued login.
    4. Enter your User Name and Password as provided by the IRB.Enter the client as “uwm”.  If you check the “Remember Client” box, “uwm” will be automatically entered each time you enter the IRBManager site from this computer.
    5. Upon initial log in, you will be required to change your password.

2.What if I forgot my password?

  1. UWM faculty, staff and students with an ePanther ID:
    Contact UWM UITS if you have issues with your ePanther ID or password.
  1. Non-UWM personnel (without an ePanther ID):
    If you have an account but forget your password, select the “Forgot Password?” option from the log in page.  Enter your full email address and uwm as the client ID. You will receive an email with a temporary password.Upon initial log in with the reset password, you will be required to change it.  Please note: you only have 3 incorrect entries before your account will be locked out and you will need to request a new password.

3.How do I change my password (for non ePanther ID Users only)?

  1. Upon initial log in, you will be required to change your password by entering your current password, your new password and confirming the new password.Select update for the change to be effective.
  2. To change your password at another time, select “UWM’s Settings” from the upper right menu.
  3. Click on “Change my password” to revise your current password
  4. You will then need to enter your old (current) password, a new password, and a confirmation of the new password. Press update for the change to be effective.If you press the back key, home key, or any other button that takes you out of this screen prior to clicking on “update,” your password change will not be recognized by the system.

4.How do I update my user information?

1.Clicking on UWM’s Settings in the upper right menu will direct you to another menu where you can view and edit any personal account or user specific settings.

a.Click on “Change my password” to revise your current password.See question 3 for details.

b.Click on “User Settings” to make a change to your first name, last name, phone number or email address.Enter the new information in the appropriate section(s) and press update for the change to be effective.

c.Click on “Address Information” to make a change to your address or add a secondary address.

i.To make a change to your address press the “hand pointing to the paper”See Figure 4.6

ii.To delete the address information press the “x” button on the line displaying the address.

iii.To add a secondary or new address click on “add address” under the actions section in the left menu.

5.How do I initiate a new study?

1.Return to your HOME page.

2.In the left menu, under the heading “Actions,” select “Start xForm.”

3.After selecting “Start xForm” from the left menu to initiate a new submission, you may print a copy of the form by selecting the printer icon or you may enter the xForm by selecting “New Study Form” in blue font.While completing the xForm, follow the instructions provided.

4.Items to consider when completing the xForm:

a.The PI and Student PI must have an IRBManager account.

b.Questions are asked in a variety of formats: short answer, check boxes, drop down menus, etc.

c.Section notes provide details and helpful information about questions.

d.Add a note allows the researcher to enter any special circumstances or notes you want the IRB reviewer to be aware of.

e.Options at the bottom of screen enable one to move through the xform.

f.At end of the xForm, attach any additional documents required for IRB review.You will find links to the current protocol form and consent templates on the attachment page.

g.After submitting a form, a message stating your form has been submitted will appear.If the screen states your form has been saved, the form was not properly submitted.Open the form to try again.

 

6.How do I submit an amendment, continuing review, or reportable event for a study that exists in IRBManager?

1.Return to your home page by clicking on the “Home” icon.

2.At the bottom center of the page, select the study number of the protocol needing a continuing review, amendment or reportable event.

3.From within the study’s protocol page, select “Start xForm” from the left menu.

4.After selecting “Start xForm,” you may print a copy of a form by selecting the printer icon to the left or you may enter an xForm by selecting the appropriate form in blue font.


7.Can a student (or coordinator or other) complete xforms?

Yes, a student PI or other contact may complete the xForms, as described above.However, before the study can be submitted to the IRB for review the PI will need to review and approve the submission.


8.How does the PI sign off on a form submitted by a SPI or another?

  1. When the SPI (or other) submits the form, the PI will receive an email with a link to the xform.The IRB will not receive the submission until after the PI signs off.
  2. If the PI no longer has the email with the link follow these instructions after logging in to IRBManager:
    1. In the center of the Home page select the option that reads," There are # xForms awaiting your attention."
    2. Any xforms awaiting PI sign off should be listed.
    3. Click on the appropriate form.
    4. After reviewing the xForm and attachments, The PI can save the review for later, print a copy, accept the study and submit to the IRB by entering his/her IRBManager password in the “Submit” box, or send the xForm back to the student PI for revisions / corrections by completing the “Reject” box.After PI enters his/her password, do not press “Enter.” The appropriate action box must be clicked on or the form will not be submitted to the IRB.
    5. After submitting a form, a message stating your form has been submitted will appear.If the screen states your form has been saved, the form was not properly submitted.Open the form to try again.
    6. If the PI requests changes, the student PI will receive an email listing the changes with a link to the xForm.After making the corrections the student PI will re-submit the xForm and the PI will receive another email requesting PI approval.

9.How will I know the status of my submission?

  1. Select the study of interest from your Home page by selecting the IRB number in blue font.
  2. Then select the event (new submission, amendment, continuing review, etc.) of interest.
  3. The steps for IRB review will then be listed with dates for expected or completed steps.

10.I submitted a study, but cannot see it listed on my Home page.

The study must be submitted by the PI of the study.After the IRB accepts the study into the system, you will receive an email stating this and then the study can be accessed from your Home page.

If you cannot find your study on your Home page, the PI may not have signed off on it yet or the IRB may not have completed its initial review to accept it into the system.To find the status of your xform, click on “You have # xForms being processed at a later stage.”Here you should find the xform and see what stage it is in.

Stage

What it Means

Who has access to the form for edits?

New Study Data Entry

Study is in progress and has NOT been submitted yet

Form Creator

New Study Data Entry (2nd time, 3rd time, etc)

Study has been sent back to the creator for revisions.

Form Creator

Awaiting PI Sign off when SPI or other submits

Study has been submitted by form creator but has not been submitted by the PI.The IRB cannot review it at this stage.

PI

Awaiting IRB to Accept into IRBmanager

The form has been submitted but has not been accepted into the system by the IRB yet.Please allow up to 2 business days for this stage.

IRB

Being Reviewed by IRB

The form has been accepted by the IRB and is in the review process.The study also has a number generated at this stage and it will be listed on the Home page.

IRB

Complete

The review is complete and the event is approved.

Form Creator

Error

Please contact the IRB if this is listed.

IRB


11. How do I submit revisions that have been requested by the IRB?

1.If revisions are requested by the IRB, ONLY the person that created the xform will receive an email with the link to the xform.However, an email with an attached letter describing these revisions will also be sent to the PI, if the study was submitted by a SPI or other.

2.If the email with the link to the study is not available, follow these instructions to access the xform:

a.In the center of the page is an option that reads, "There are #xForms awaiting your attention."  Click on that.

b.Any xforms awaiting your completion should be listed.

c.Click on the appropriate form.

3.To complete the revisions:

a.Highlight, bold, or underline each revision in the appropriate document.

b.Re-attach each revised document to the original study x-form.

c.In addition, attach a cover memo to the x-form that explains how each requested revision has been addressed.

d.Resubmit the x-form to the IRB for review.If you are not the PI, the PI will receive an email notification that sign off for the study is required before the revisions are submitted to the IRB.When you have fulfilled the requested revisions, you will be notified by email about the status of your protocol.


12.How will I know when my study is approved?

Primary contacts for a study will receive an email to notify of IRB approval.In addition, you may view study status by following the steps in question 9 above.Approval letters can be found as attachments in the study event page.


13.How can I add other investigators, research assistants, etc. to my study?

1.At the bottom center of your HOME page, select the study number of the protocol of interest.

2.Select the “Add Protocol Site – Contact” option from the left menu.

3.You can then add the name of the contact by typing the first or last name into the text box.Followed by the “Enter” key.

    1. If multiple IRBManager users, have the same first or last name, a drop down list will appear for the correct contact to be added.
    2. Please note entering a single letter (followed by the “Enter” key) will create a drop down list of IRBManager users with a first or last name beginning with that letter.
    3. You may also enter a series of letters in the middle of a name by adding the percent symbol before and after the letters. (%and%)
    4. If the name of your contact is not found, he/she will need to request a user account by visiting the UWM IRB website: (http://www4.uwm.edu/usa/irb/researchers/irbmanager.cfm)
  1. You will then assign a role to the contact.Please note that Co-Investigator, Coordinators, and Faculty Advisors will be copied on all IRB notifications about study expirations, but Research Assistants, consultants and cc recipients will not receive those notifications.
  2. Select the green check mark to complete the contact addition.
  3. The contact will now have access to the study through the IRBManager system.
  4. The contact may complete amendment, continuing review, and reportable event xForms for the designated study.However, the PI will need to review and approve the forms before it is submitted to the IRB for review through the system.

14.I submitted my continuing review but I continue to receive reminders about the upcoming expiration.Do I need to do anything?

No, you do not need to do anything.The reminders will continue to be sent until the IRB office has accepted the form into the system.Final approval is completed as close to the expiration date as possible.Follow #9 or #10 above to check the status of your submission.


15.How do I find attachments for studies that have been approved or that are under review by the IRB?

On your IRBManager home page, find the list of studies on the bottom half of the page.Click on the study of interest.Once in the study home page, find the event associated with the documents you are looking for- New Study Submission, Amendment submission, etc…- and click the even name.On the next screen, the event home page, there will be a menu of “Actions” on the left side of the screen.Find “Attachments” and click on that to bring you to a page that will list all of the documents associated with that event and study.


16.  Can I share an xForm with others during the writing/editing process so they can review and edit the xform?

 Yes, you may now share an xForm with others during the writing/editing stage. Collaboration will allow a person other than the author of the form to edit, manage, and/or submit an xform. This option will allow other co-investigators or team members (with an IRBManager account) to assist the author of the form with reviewing, editing and/or submitting.

 As an example:

Previously, a faculty PI was only able to review a student’s xform after the student submitted it to the PI for “sign off.”If the PI found an error or wanted a correction, the PI would need to “reject” the form back to the student for revisions.

 NOW, the student can add the faculty PI as a collaborator and the faculty PI can review the form as the student works on it, make changes to the form, add attachments to the xform, and/or submit the form to the IRB.  As soon as the student adds the PI as a collaborator, the PI will receive an automatic email with a link to the xform.  In addition, the faculty PI will be able to find the xform in in the “xForms awaiting your attention” section of his/her IRBManager Home page.

 The author can share access to an xform by:

1.At the top of each page of the xForm, select “Collaborators.”

2.A new box will open:

a.Enter the email of the person you wish to share access to the form with.

b.Select the type of access you want the person to have:

i.Edit – This will allow the person to edit the form.

ii.Edit and Manage –This will allow the person to edit the form AND invite new collaborators.

iii.Edit, manage and submit – This will allow the person to edit the form AND invite new collaborators AND submit the study.

c.You may add text to the “Note for Collaborator” box and this information will be included in the automatic email that notifies the collaborator that they have access to the form.

d.Select the “Add” Box.

e.The collaborator will automatically be sent an email to notify him/her that he/she has access to the form. The email will include a link to the form or the collaborator can find the form in the “xForms awaiting your attention” section of his/her IRBManager Home page.

f.The list of current collaborators will be listed at the bottom of the box.

3.You may view, add or remove collaborators at any time by selecting the “Collaborators” link at the top of each page of the xForm.