Welcome to the e-IRB Guide version 3.0, 1/06/14

1. Welcome to the e-IRB Guide version 3.0, 1/06/14 For the first time in January 2014 investigators will be able to submit their IRB application online via the electronic IRB system (e-IRB) The purpose of this guide is to help investigators understand how to navigate and complete a protocol using via the e-IRB system.

2. Table of Contents • Basic Overview: • Main Menu • Files & Documents • Create New Protocols • e-IRB Online Form • Uploading Protocol as a Document • View and Edit Existing Protocols • Check-out | Check-in Procedure • Uploading Training Documents • Submitting and Signing the Protocol • How do I filter through protocol archive? • How do I share the protocol with others? • What are User or PI groups? • How do off campus collaborators log into e-IRB?

3. First Step: Registering as a “User” Users of the e-IRB system are parties interested in conducting human research through the Cal Poly Pomona IRB. This includes both affiliated and unaffiliated investigators. Investigators desiring to access the e-IRB system must first have an account created for them by the IRB administrators. To request an account send an email the IRB administrators irb@csupomona.edu, more details about this process will be on the next slide.

4. Registering as a New User Continued When sending an email to the IRB administrator be sure to use the following format to expedite your request: Title the email: “(Your Name), New eIRB Account Request”. In the body of the mail include your Bronco login name (this will be the e-IRB user name). If you are unaffiliated and not have a Bronco login contact the IRB administrator. In the body indicate which email address you prefer to use for the delivery of messages from the e-IRB system. If this information is not provided the administrator will use the ‘reply address’ by default.

5. General Browser Advice The e-IRB system is maximized for Internet Explorer. While other browsers (Safari, Chrome, Firefox) do work, users may experience errors while navigating through the e-IRB system. • Popup blockers may interfere with the functionality of the e-IRB system.

6. Overview: Learning Objectives • The objective of the overview slides is to briefly introduce certain elements specific to the electronic IRB system such as: • Main menu, Files & documents, and actual protocol screens. • Users will also learn how to check-in and check-out documents, and know differences between the two statuses.

7. Overview: Main Menu This is the Main Menu screen and start screen for all users. The main menu provides a path to files and documents (protocols) Left clicking on Files & Documents will give you access to enter protocol listing screen. IRB Office Use Only

8. Overview: Files & Documents This is the Files & Documents screen, here users can create new and gain access to edit existing protocols.

9. Overview: Information Buttons Throughout the protocol there are info-buttons that give additional explanations to investigators. Hover the mouse over the info button to reveal the content. Some sections are less ambiguous, these sections will have an unused info-button.

10. Overview: Files & Documents Some other pertinent functions in this menu include: Location protocols are electronically signed or signatures uploaded. Uploading optional hardcopy attachment of the IRB protocol. Close or withdraw protocols. Check in and check out protocols. (see Check in | Check out slides)

11. Overview: Protocol Screen This is a screen of the actualprotocol, here users will be able complete/edit their protocol application. Note the protocol number will always be displayed in the top left corner (circled) e.g. in this case 13-0025 (protocol #) 8.0 (8th version).

12. Overview: Protocol Screen Some other pertinent functions while navigating within the protocol include: Responding to reviewer comments. Compare different versions of the protocol application. Upload pertinent attachments relating to the protocol by category (i.e. special permissions, recruitment materials etc.)

13. Creating a New Protocol: Gather Your Materials This brief walkthrough of how to create a new protocol. These slides will teach users how to move the protocol from a draft to being ready for administrative review. For more information on IRB policy users are suggested to visit the Cal Poly Pomona Institutional Review Board (IRB) website: http://www.csupomona.edu/~research/irb/index.shtml

14. Create New Protocol: Main Menu Left click to proceed to Files & Documents (this will allow you to create/edit/view to edit your protocols.

15. Create new protocol: Protocol Listing Page Click this icon to reveal the “new” button. Then select “new” to create a new protocol. *Note this will create a new pop up window.

16. Create New Protocol There are two ways to create a new protocol Access the e-IRB system online, and fill out the form online. Access the e-IRB system, and upload a text document (Word or PDF) instead of entering the data on the e-IRB application. The next several slides will cover how to enter the e-IRB online.

17. Create New Protocol: Create IRB Template From the pop-up window select Institutional Review Board Protocol (IRBP) from the drop down menu, then select next.

18. Create New Protocol: Enter a Title Again, remember to retain protocol number for your records. Enter the title of the protocol, you may change this title later should you desire. Be sure to note the automatically assigned protocol number then select save and open document. *Note this will close the pop-up window automatically and open the new protocol on the next screen.

19. Create New Protocol: Protocol Screen Navigation You can always find protocol and version numbers here, in this case: protocol #13-0026 version 1.0 Back button will exit the current protocol, returning users back to the protocol listing (Files & Documents) page Left Click on Action for saving and printing options. It is strongly advised that save your progress at each session tab before proceeding to the next section. Left Click to on sections tabs to navigate through protocol To navigate back within a protocol use the section tabs.

20. New Protocol:Protocol and Version Number • The number listed to the IRBP is the protocol and version. • As a PI the most important part is likely the protocol number, e.g. is 13-0026. • The version number has two elements (1.0): the document state and the save version respectively.

21. Create New Protocol: Fill Out Each Section Tab Navigate to each section tab, and fill out the all sections

22. Create New Protocol: Fill Out Protocol Re-enter protocol name First left click on you wish to edit e.g. Title/ General tab Enter anticipated protocol duration. Select the appropriate category for vulnerability and permissions.

23. Create New Protocol: Assigning Roles To assign roles for PIs & co-PIs (other investigators) click the edit selection box, this will open a new pop-up window.

24. Create New Protocol: Assigning Roles In the pop-up window click on the term “Teams”, this will display a drop-down menu so that you can select individuals to assign roles. When you have finished assigning roles select apply current selection to save and return to the main screen.

25. 9. Fill Out all Sections Navigate to each section and complete each entry, excluding Workflow History.

26. Create New Protocol There are two ways to create a new protocol Access the e-IRB system online, and fill out the form online. Access the e-IRB system, and upload a text document (Word or PDF) instead of entering the data on the e-IRB application. The next several slides will cover how to upload a protocol.

27. First Create Placeholder Protocol Listing Click this icon to reveal the “new” button. Then select “new” to create a new protocol. *Note this will create a new pop up window.

28. Create New Protocol: Enter a Title Again, remember to retain protocol number for your records. Enter the title of the protocol, you may change this title later should you desire. Be sure to note the automatically assigned protocol number then select save and open document. *Note this will close the pop-up window automatically and open the new protocol on the next screen.

29. Uploading MSWord Version of Protocol Users wishing to upload a MSWord version of the completed protocol can do so at the Files & Documents screen. From Files & Documents, right click on the protocol, then select Add Attachment to browse and upload your protocol. Be sure to label the attachment as “IRB_protocol number”, e.g. “IRB_13.0026”. If you have correctly uploaded a document from this screen then a paperclip will appear upon refreshing.

30. Create New Protocol: Submittal Checklist Prior to submitting the protocol use the checklist provided in the section tab Instructions / Checklist to ensure your protocol is complete.

31. Sign Protocol & Submit for Administrative Review Completed draft protocols must be signed by all investigators prior to submittal to the IRB for review. There are two ways to sign a protocol: Sign protocol with your e-IRB login password. Submit scanned signature as an attachment from the Files and Documents screen.

32. Signing Protocol Electronically First, right click on the protocol, then select Signatures

33. Signing Protocol Electronically First, enter your e-IRB password, then select Sign to electronically sign the protocol.

34. Create New Protocol: Uploading Signatures Users may upload a hard copy of the protocol, then send a signed protocol cover page only. (See more on this here) Alternatively, users may upload standard image file of their signature(s) to sign a protocol.

35. Uploading a Signature While in Files and Documents right click on protocol, and select Add Attachment to upload a signature.

36. Signed & Ready for Submittal • Ready for submittal? • Have all the investigators signed the protocol? • Have all the supporting documents been attached or sent to the IRB office? • Have all the applicable sections been filled out to the best ability of the investigators? • Have you completed the checklist located in the Instructions / Checklist tab? • If you answered yes to all of the questions, then your protocol is likely ready for submittal to the IRB office– always verify with your research team before submittal. Administrative review of the protocol will only start after the Principal Investigators both changes the status of the protocol to Administrative Review notifies the IRB office that the protocol is ready for reviewby emailing: irb@csupomona.edu • The next slide will cover how PIs can change the protocol to Administrative Review .

37. Submitting for Admin Review (R) Click on protocol, then select Administrative Review.

38. SUBMIT PROTOCOL Select OK (OPTIONAL) You may write a comment to the administrative reviewer.

39. Ready for Administrative Review After the PI has marked the protocol as ready by selecting “Administrative Review” the PI should then notify the IRB office that the protocol via email at irb@csupomona.edu When it is time for the PI to respond to the review the document state will indicate “For Revision”.

40. Overview: Check-in | Check-Out Protocol The e-IRB introduces the concept of checking in or out a protocol. The next slides will demonstrate how the check-in | check-out process works.

41. Overview: Check Out A user checking out a protocol is analogous to checking out the sole copy of a library book, i.e. only one user can have a protocol checked-out at a time. Once a user has a protocol checked-out to them they will be able to modify the content of the protocol. Its important to note that only users with check-out privileges will be able to edit the protocol. Alternatively, users may check-in the protocol so others users may modify it.

42. Overview: Protocol Check-Out When a new protocol is created the author is automatically given check-out privileges to the protocol. To manually check out a protocol, from the Files & Document screen right click on the protocol you wish to edit to bring up more options, then left click on “Check-Out Document”:

43. Overview: Protocol Check-Out After selecting “Check-Out Document” the icon will display next to the protocol in the Files & Documents screen.

44. Overview: Protocol Check-In Checking-in a protocol allows for other users within the research team to edit the document should they it check-out. To check in a document, from the Files & Document screen right click on the protocol you wish to edit to bring up more options, then left click on “Check-In Document”, this will make the check-out icon disappear.

45. Overview: Protocol Check-In When a protocol is already checked out by another user the “already checked out” icon will appear. This icon lets users know that while the protocol is viewable it can not be edited by the current user until it is checked in.

46. Overview: Check-In Reminder Upon logging out of the e-IRB system, an automatic prompt will be generated to remind users to check-in documents. Note that the IRB office doesn’t track research team check statuses, therefore it is suggested, to avoid conflicts, that research teams develop their own standard operating procedures for checking in and out.