Welcome to IRBManager! To access IRBManager, type the following address in your web browser: Enter your username and password For “client”, enter “uindy”

Initial Access to IRBManager

Contact Greg Manship at (317) or to obtain a username and password.

Change Your Password After Your Initial Login  At initial login, system will force you to change password.  Enter OLD password, enter NEW password, and then CONFIRM NEW password.

Changing Your Password at Another Time  In upper right of screen, click on “(your name) settings”  At next screen, click on blue link “Change my password”

Changing Your Password at Another Time (cont.)  At “Change password” screen, type in OLD password, NEW password, and then CONFIRM NEW password

IRBManager Forms  You can complete up to six (6) forms for a particular protocol: New Protocol Application New Protocol Application Revision to a Protocol Prior to Approval Revision to a Protocol Prior to Approval Revision to a Previously Approved Protocol Revision to a Previously Approved Protocol Project Update (Continuing Review) Project Update (Continuing Review) Adverse Event Form Adverse Event Form Project Closure 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 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 From anywhere in IRBManager, click the link for ‘xForms’ under My Documents & Forms, then click on the link for ‘Start Form’ under Actions 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 address. The PI must be UIndy faculty/staff. For student projects, the PI is the faculty adviser. The PI must be UIndy faculty/staff. For student projects, the PI is the faculty adviser. If the address is not found, please contact Greg at x5774 If the address is not found, please contact Greg at x5774 If the address is found, the contact information for the PI will be pulled into the application. Proceed with completion of the application If the address is found, the contact information for the PI will be pulled into the application. Proceed with completion of the application

The PI must be UIndy faculty/staff

New Protocol Application (cont.)  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 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

New Protocol Application (cont.)  The next page allows you to list non-investigator personnel who do NOT (1) interact with participants and/or (2) do not analyze data.  Complete this page as you did for co- investigators.

New Protocol Application (cont.)  Complete subsequent screens by filling in the fields with appropriate information.  When you arrive at the ‘Devices and Drugs’ screen (screen/page 8), answer “no” for the questions regarding drug and device use if none will be used. Leave blank the answer to question, “Is the device FDA approved?” Please contact the IRB Office if you study will involve the administration of drugs or devices.  Continuing from the ‘Devices and Drugs’ screen, complete the information on the remaining screens, which will eventually bring you to the ‘Attachments’ screen

New Protocol Application (cont.)  The ‘Attachments’ screen (screen/page 14) is where the PI will attach the following documents (as applicable): Recruitment materials Recruitment materials Informed consent document Informed consent document Assent document Assent document Parental permission document Parental permission document “Children as Research Participants” document “Children as Research Participants” document Interview questions Interview questions Letter of cooperation from non-UIndy affiliated sites Letter of cooperation from non-UIndy affiliated sites IRB approval letters from other institutions where the research will be conducted IRB approval letters from other institutions where the research will be conducted Questionnaires that will be distributed to participants Questionnaires that will be distributed to participants Demographic information sheets that will be distributed to participants Demographic information sheets that will be distributed to participants Any other data collection instrument not aforementioned Any other data collection instrument not aforementioned Reference list that corresponds with “Findings from the Literature” Reference list that corresponds with “Findings from the Literature”

New Protocol Application (cont.)  Submitting User screen/page Department chair is required Department chair is required A list of department chairs can be found at list of department chairs can be found at PI or Co-PI password is also required for submission 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.

for protocol approval  If you are the submitting PI, you will receive an 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 Revision to a Previously Approved Protocol Adverse Event Form Adverse Event Form Project Closure Form Project Closure Form These forms can be saved for revisions just like the new protocol application formThese 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.) 1

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

Administrative Functions My Settings (cont.)  Click on “User Settings” to access settings page.

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 by selecting “Address Information”.

Address Information (cont.)  To edit information, click on the “action” (hand) icon.

Address Information (cont.)  The PI can also view an audit report of past changes made to his or her address.  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