welcome to irbmanager! to access irbmanager, type the following address in your web browser:
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Welcome to Welcome to IRBManager!IRBManager!
To access IRBManager, type the following To access IRBManager, type the following address in your web browser: address in your web browser: https://login.irbmanager.com/
Enter your username and passwordEnter your username and passwordFor “client”, enter “uindy”For “client”, enter “uindy”
Initial Access to IRBManagerInitial Access to IRBManager
Change Your Password After Change Your Password After Your Initial LoginYour Initial Login
At initial login, At initial login, system will system will force you to force you to change change password.password.
Enter OLD Enter OLD password, enter password, enter NEW password, NEW password, and then and then CONFIRM NEW CONFIRM NEW password.password.
Changing Your Password at Changing Your Password at Another TimeAnother Time
In upper In upper right of right of screen, click screen, click on “(your on “(your name) name) settings”settings”
At next At next screen, click screen, click on blue link on blue link “Change my “Change my password”password”
Changing Your Password at Changing Your Password at Another Time (cont.)Another Time (cont.)
At “Change At “Change password” password” screen, type screen, type in OLD in OLD password, password, NEW NEW password, password, and then and then CONFIRM CONFIRM NEW NEW passwordpassword
IRBManager FormsIRBManager Forms
You can complete up to six (6) forms for a You can complete up to six (6) forms for a particular protocol:particular protocol: New Protocol ApplicationNew Protocol Application Revision to a Protocol Prior to ApprovalRevision to a Protocol Prior to Approval Revision to a Previously Approved ProtocolRevision to a Previously Approved Protocol Project Update (Continuing Review)Project Update (Continuing Review) Adverse Event FormAdverse Event Form Project Closure FormProject Closure Form
New Protocol ApplicationNew Protocol Application
The new protocol application form is made up of The new protocol application form is made up of 15 screens (or pages) for the PI or Co-PI to 15 screens (or pages) for the PI or Co-PI to completecomplete
This form can be saved at anytime by clicking on This form can be saved at anytime by clicking on the ‘Save for Later’ button at the bottom of the the ‘Save for Later’ button at the bottom of the formform
You may also go back a page at any time to You may also go back a page at any time to make changes. (Hitting the ‘back’ button will make changes. (Hitting the ‘back’ button will require you to refresh the data when prompted)require you to refresh the data when prompted)
New Protocol Application New Protocol Application (cont.)(cont.)
Creating a new protocol can be done in Creating a new protocol can be done in one of two ways:one of two ways:
From inside a protocol, click on the link for From inside a protocol, click on the link for ‘Start xForm’ under ‘Start xForm’ under ActionsActions, (a second , (a second window will pop-up), then click on the link for window will pop-up), then click on the link for ‘New Protocol Application’ in the list of forms‘New Protocol Application’ in the list of forms
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New Protocol Application New Protocol Application (cont.)(cont.)
• From anywhere in IRBManager, click the From anywhere in IRBManager, click the link link
for ‘xForms’ under for ‘xForms’ under My Documents & My Documents & FormsForms, , then click on the link for ‘Start Form’ then click on the link for ‘Start Form’ under under ActionsActions
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New Protocol ApplicationNew Protocol Application(cont.)(cont.)
On the first page of the application (titled On the first page of the application (titled Protocol Information), the PI will be asked to Protocol Information), the PI will be asked to enter his or her e-mail address.enter his or her e-mail address. The PI must be UIndy faculty/staff. For student The PI must be UIndy faculty/staff. For student
projects, the PI is the faculty adviser. projects, the PI is the faculty adviser. If the e-mail address is not found, please contact If the e-mail address is not found, please contact
Greg at x5774Greg at x5774 If the e-mail address is found, the contact If the e-mail address is found, the contact
information for the PI will be pulled into the information for the PI will be pulled into the application. Proceed with completion of the application. Proceed with completion of the applicationapplication
The PI must be UIndy faculty/staff
New Protocol Application (cont.)New Protocol Application (cont.)
Once the first screen (page) is completed, the Once the first screen (page) is completed, the next screen is information for the Co-PI(s)next screen is information for the Co-PI(s)
This screen differs from the PI screen in that it is This screen differs from the PI screen in that it is possible to enter the Co-PI’s information into the possible to enter the Co-PI’s information into the application if he or she is not found by his or her application if he or she is not found by his or her e-mail addresse-mail address
If there are multiple Co-PI’s, then click on the If there are multiple Co-PI’s, then click on the ‘Repeat’ button at the bottom of the form after ‘Repeat’ button at the bottom of the form after the first Co-PI’s information has been enteredthe first Co-PI’s information has been entered
Once all Co-PI information has been entered, Once all Co-PI information has been entered, proceed with the next pages of the applicationproceed with the next pages of the application
New Protocol Application (cont.)New Protocol Application (cont.)
The next page The next page allows you to list allows you to list non-investigator non-investigator personnel who personnel who do NOT (1) do NOT (1) interact with interact with participants participants and/or (2) do not and/or (2) do not analyze data.analyze data.
Complete this Complete this page as you did page as you did for co-for co-investigators.investigators.
New Protocol Application (cont.)New Protocol Application (cont.) Complete subsequent screens by filling in the Complete subsequent screens by filling in the
fields with appropriate information.fields with appropriate information. When you arrive at the ‘Devices and Drugs’ When you arrive at the ‘Devices and Drugs’
screen (screen/page 8), answer “no” for the screen (screen/page 8), answer “no” for the questions regarding drug and device use if none questions regarding drug and device use if none will be used. Leave blank the answer to will be used. Leave blank the answer to question, “Is the device FDA approved?” Please question, “Is the device FDA approved?” Please contact the IRB Office if you study will involve contact the IRB Office if you study will involve the administration of drugs or devices.the administration of drugs or devices.
Continuing from the ‘Devices and Drugs’ screen, Continuing from the ‘Devices and Drugs’ screen, complete the information on the remaining complete the information on the remaining screens, which will eventually bring you to the screens, which will eventually bring you to the ‘Attachments’ screen‘Attachments’ screen
New Protocol ApplicationNew Protocol Application(cont.)(cont.)
The ‘Attachments’ screen (screen/page 14) is where the PI will The ‘Attachments’ screen (screen/page 14) is where the PI will attach the following documents (as applicable):attach the following documents (as applicable):
Recruitment materialsRecruitment materials Informed consent documentInformed consent document Assent documentAssent document Parental permission documentParental permission document ““Children as Research Participants” documentChildren as Research Participants” document Interview questionsInterview questions Letter of cooperation from non-UIndy affiliated sitesLetter of cooperation from non-UIndy affiliated sites IRB approval letters from other institutions where the research will be IRB approval letters from other institutions where the research will be
conductedconducted Questionnaires that will be distributed to participantsQuestionnaires that will be distributed to participants Demographic information sheets that will be distributed to participantsDemographic 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 ApplicationNew Protocol Application(cont.)(cont.)
Submitting User screen/pageSubmitting User screen/page Department chair e-mail is requiredDepartment chair e-mail is required
• A list of department chairs can be found at A list of department chairs can be found at http://irb.uindy.edu/admin_approval.phphttp://irb.uindy.edu/admin_approval.php
PI or Co-PI password is also required for PI or Co-PI password is also required for submissionsubmission
Once the required information is filled in, click Once the required information is filled in, click ‘next’ and you will have one more opportunity ‘next’ and you will have one more opportunity to save for revisions before submission, or to save for revisions before submission, or you can submit from here.you can submit from here.
E-mail for protocol approvalE-mail for protocol approval If you are the submitting PI, you will If you are the submitting PI, you will
receive an e-mail like this:receive an e-mail like this:
Protocol FormsProtocol Forms
The following forms can be created using The following forms can be created using the same procedures as described for the same procedures as described for creating a new protocol application from creating a new protocol application from within the protocol:within the protocol: Revision to a Previously Approved ProtocolRevision to a Previously Approved Protocol Adverse Event FormAdverse Event Form Project Closure FormProject Closure Form
• These forms can be saved for revisions just like These forms can be saved for revisions just like the new protocol application formthe new protocol application form
Protocol FormsProtocol Forms(cont.)(cont.)
Project Update (Continuing Review) Project Update (Continuing Review) Creating this form is slightly different from Creating this form is slightly different from
the process for creating the the process for creating the aforementioned formsaforementioned forms
Go to protocol for which you would like to Go to protocol for which you would like to create a continuing review formcreate a continuing review form
In the In the EventsEvents section, click the link for section, click the link for ‘continuing review’‘continuing review’
Continuing Review form Continuing Review form (cont.)(cont.)
Under Under ActionsActions click the link for ‘Start click the link for ‘Start xForm’xForm’
In the pop-up window, select the link In the pop-up window, select the link ‘Project Update (Continuing Review) Form’‘Project Update (Continuing Review) Form’
Continuing Review form Continuing Review form (cont.)(cont.)
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Administrative FunctionsAdministrative FunctionsMy SettingsMy Settings
In the In the My SettingsMy Settings link, there are four link, there are four areas in which information pertaining to areas in which information pertaining to your account are stored. These are:your account are stored. These are: Change My PasswordChange My Password User SettingsUser Settings Address InformationAddress Information Last 25 LoginsLast 25 Logins
Administrative FunctionsAdministrative FunctionsMy Settings (cont.)My Settings (cont.)
Click on “User Click on “User Settings” to Settings” to access access settings page.settings page.
User SettingsUser Settings
Here, the Here, the PI can PI can make make changes changes to his or to his or her name, her name, phone phone number, number, and e-and e-mail mail addressaddress
Address InformationAddress Information
Changes to Changes to the PI’s the PI’s address can address can be made by be made by selecting selecting “Address “Address Information”. Information”.
Address Information (cont.)Address Information (cont.)
To edit To edit information, information, click on the click on the “action” “action” (hand) icon.(hand) icon.
Address Information (cont.)Address Information (cont.)
The PI can also The PI can also view an audit view an audit report of past report of past changes made changes made to his or her to his or her address.address.
The PI can The PI can also add other also add other addresses by addresses by clicking the link clicking the link for ‘Add for ‘Add Address’ under Address’ under ActionsActions
Last 25 LoginsLast 25 LoginsThis is a useful report for instances where unauthorized This is a useful report for instances where unauthorized
use may be suspecteduse may be suspected