Welcome to IRBManager! To access IRBManager, type the following address in your web browser:

Welcome to IRBManager!

To access IRBManager, type the following address in your web browser: https://irbmanager.becirb.com

Enter your username and passwordFor ‘client’, enter uindy

https://irbmanager.becirb.com/

Initial Access to IRBManager

Your email

address

Change My Password

IRBManager Forms

There are five forms in IRBManager that can be created. These are the forms: New Protocol Application Revision to a Previously Approved Protocol Project Update (Continuing Review) Adverse Event Form Project Closure Form

New Protocol Application

The new protocol application form is made up of 15 screens (or pages) for the PI or Co-PI to complete

This form can be saved at anytime by clicking on the ‘Save for Later’ button at the bottom of the form

You may also go back a page at any time to make changes. (Hitting the ‘back’ button will require you to refresh the data when prompted)

New Protocol Application (cont.)

Creating a new protocol can be done in one of two ways:

From inside a protocol, click on the link for ‘Start xForm’ under Actions, (a second window will pop-up), then click on the link for ‘New Protocol Application’ in the list of forms

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New Protocol Application (cont.)

• From anywhere in IRBManager, click the link

for ‘xForms’ under My Documents & Forms, then click on the link for ‘Start Form’ under Actions

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New Protocol Application(cont.)

On the first page of the application (titled Protocol Information), the PI will be asked to enter his or her e-mail address. If the e-mail address is not found, please

contact Cory at x2063 If the e-mail address is found, the contact

information for the PI will be pulled into the application. Proceed with completion of the application


Once the first screen (page) is completed, the next screen is information for the Co-PI(s)

This screen differs from the PI screen in that it is possible to enter the Co-PI’s information into the application if he or she is not found by his or her e-mail address

If there are multiple Co-PI’s, then click on the ‘Repeat’ button at the bottom of the form after the first Co-PI’s information has been entered


Once all Co-PI information has been entered, proceed with the next pages of the application

When you get to the ‘Devices and Drugs’ screen (screen/page 8), please leave the pull-down blank for the question “Is this device FDA-approved?” (if none will be used)

Continuing from the ‘Devices and Drugs’ screen, complete the information on the remaining screens, which will eventually bring you to the ‘Attachments’ screen


The ‘Attachments’ screen (screen/page 14) is where the PI will attach the following documents (as applicable):

Recruitment materials Informed consent document Assent document Parental permission document Interview questions Letter of cooperation from non-UIndy affiliated sites IRB approval letters from other institutions where the research will be

conducted Questionnaires that will be distributed to participants Demographic information sheets that will be distributed to participants Any other data collection instrument not aforementioned


FYI for attachments page – if there are multiple items for a single category (i.e. multiple informed consent letters), please combine them into a single document before attaching them


Submitting User screen/page Department chair e-mail is required PI or Co-PI password is also required for

submission

Once the required information is filled in, click ‘next’ and you will have one more opportunity to save for revisions before submission, or you can submit from here.

E-mail for protocol approval If you are the submitting PI, you will

receive an e-mail like this:

Protocol Forms

The following forms can be created using the same procedures as described for creating a new protocol application from within the protocol: Revision to a Previously Approved Protocol Adverse Event Form Project Closure Form

• These forms can be saved for revisions just like the new protocol application form

Protocol Forms(cont.)

Project Update (Continuing Review) Creating this form is slightly different from

the process for creating the aforementioned forms

Go to protocol for which you would like to create a continuing review form

In the Events section, click the link for ‘continuing review’

Continuing Review form (cont.)

Under Actions click the link for ‘Start xForm’

In the pop-up window, select the link ‘Project Update (Continuing Review) Form’

Continuing Review form (cont.)

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Administrative FunctionsMy Settings

In the My Settings link, there are four areas in which information pertaining to your account are stored. These are: Change My Password User Settings Address Information Last 25 Logins

User Settings

Here, the PI can make changes to his or her name, phone number, and e-mail address

Address Information

Changes to the PI’s address can be made here. The PI can also view an audit report of past changes made to his or her address.

In order to make a change to the address, the PI must click on the hand to the left of the ‘X’ under Action column

The PI can also add other addresses by clicking the link for ‘Add Address’ under Actions

Last 25 Logins

This is a useful report for instances where unauthorized use may be suspected