1. Welcome to IRBManager! To access IRBManager, type the following address in your web browser: https://irbmanager.becirb.com https://irbmanager.becirb.com Enter your username and password For client, enter uindy

2. Initial Access to IRBManager

3. Your email address

4. Change My Password

5. IRBManager Forms There are five forms in IRBManager that can be created. These are the forms: There are five forms in IRBManager that can be created. These are the forms: New Protocol Application New Protocol Application 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

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

7. New Protocol Application (cont.) Creating a new protocol can be done in one of two ways: 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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9. 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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11. 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. 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 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 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

13. New Protocol Application (cont.) Once the first screen (page) is completed, the next screen is information for the Co-PI(s) 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-PIs information into the application if he or she is not found by his or her e-mail address This screen differs from the PI screen in that it is possible to enter the Co-PIs information into the application if he or she is not found by his or her e-mail address If there are multiple Co-PIs, then click on the Repeat button at the bottom of the form after the first Co-PIs information has been entered If there are multiple Co-PIs, then click on the Repeat button at the bottom of the form after the first Co-PIs information has been entered

15. New Protocol Application (cont.) Once all Co-PI information has been entered, proceed with the next pages of the application 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) 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 Continuing from the Devices and Drugs screen, complete the information on the remaining screens, which will eventually bring you to the Attachments screen

17. New Protocol Application (cont.) The Attachments screen (screen/page 14) is where the PI will attach the following documents (as applicable): 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 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

18. New Protocol Application (cont.) 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 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

19. New Protocol Application (cont.) Submitting User screen/page Submitting User screen/page Department chair e-mail is required Department chair e-mail is required 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.

21. E-mail for protocol approval If you are the submitting PI, you will receive an e-mail like this: If you are the submitting PI, you will receive an e-mail like this:

22. Protocol Forms The following forms can be created using the same procedures as described for creating a new protocol application from within the protocol: 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

23. Protocol Forms (cont.) Project Update (Continuing Review) Project Update (Continuing Review) Creating this form is slightly different from the process for creating the aforementioned forms 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 Go to protocol for which you would like to create a continuing review form In the Events section, click the link for continuing review In the Events section, click the link for continuing review

24. Continuing Review form (cont.) Under Actions click the link for Start xForm Under Actions click the link for Start xForm In the pop-up window, select the link Project Update (Continuing Review) Form In the pop-up window, select the link Project Update (Continuing Review) Form

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27. Administrative Functions My Settings In the My Settings link, there are four areas in which information pertaining to your account are stored. These are: 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

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

30. Address Information Changes to the PIs address can be made here. The PI can also view an audit report of past changes made to his or her address. Changes to the PIs 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 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 The PI can also add other addresses by clicking the link for Add Address under Actions

32. Last 25 Logins This is a useful report for instances where unauthorized use may be suspected This is a useful report for instances where unauthorized use may be suspected