Welcome to the Cal Poly Pomona e-IRB Guide

1. Welcome to the Cal Poly Pomona e-IRB Guide • The purpose of this guide is to help investigators understand how to navigate and complete a protocol using the e-IRB system. Version 10/2/14.

2. Table of Contents • Before you Begin • Learning Objectives • Registering as a “New eIRB User” and Logging on • eIRB Main Screen • Files and Documents • Information Icons • Protocol Form • Creating a New Protocol • Option 1: Creating a New Protocol Through the eIRB System • Option 2: Uploading a Protocol as a Document on the e-IRB • Attaching Supporting Protocol Documents • Protocol Form Checklist • Signing a Protocol • Signing Protocol Electronically • Submitting a Protocol • For Administrative review • Protocol Status Change • Revising a Protocol • Check-in | Check-Out Protocol • Viewing and Responding to Comments • Approved Protocol • Thank you

3. Before you Begin… 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 will interfere with the functionality of the e-IRB system. If this does occur, make sure to set the pop-up blocker to “Always Allow Pop-Ups from this site.” • If you are a Mac user, please visit the FAQ section on our website for instructions on how to allow pop-ups. Remember to… • Review regulations, policies, procedures, etc. - Review the other pages of the IRB website for information and details regarding the essence of the human study protocol process. • Complete CITI training- All people involved in conducting the research (investigator, advisor, and co-investigators) are required to complete CITI training for approval of your IRB protocol. Visit the CITI web page for coursework on aspects of research with human volunteers. Go to the section on "Continuing Education and Training" for instructions and details as well as other training opportunities.

4. Registering as a “New eIRB User“ and Logging on

5. Registering as a New eIRB User (cont.) When sending an email to the IRB administrator be sure to use the following format to expedite your request: 1. Title the email: “(Your Name), New eIRB Account Request”. 2. In the body of the mail include: Salutation (PhD,MS, BS, etc.),First and last name, Bronco ID, Bronco email (csupomona email), Status (faculty, staff, student, unaffiliated, etc.), College/Department, and Phone number. 3.Once a login ID has been provided to you, go to the e-IRB access portal located on the IRB website (Under “Getting started with a protocol” Tab”) to gain access to the e-IRB site. 4. All steps are required.  For those PIs who have already met all of the criteria, simply check the boxes and you'll be in the eIRB quickly.

6. e-IRB Main Menu Screen This is the Main Menu screen and start screen for all users. The main menu provides a path to files and documents (protocols). Think of the “File” being a folder in which you will store your documents. Likewise, think of the “Documents” as being your protocol and any other attachments such as, consent forms, permissions, survey print-out, etc. Left clicking on Files & Documents will give you access to enter protocol listingscreen. IRB Office Use Only

7. Files & Documents This is the Files & Documents screen. Here users can create new and gain access to edit existing protocols. Some other pertinent functions in this menu include: Locating protocols and electronically sign or upload signature page. Uploading optional hardcopy attachment of the IRB protocol. Close or withdraw protocols. Check in and check out protocols (see Check in | Check out slides).

8. Protocol Form 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 14-0033 (protocol #) 1.0 (1st version). Protocol number and version. Left Click on Action for saving and printing options. Back button will exit the current protocol, returning users back to the protocol listing (Files & Documents) page It is strongly advised that save your progress at each session tab before proceeding to the next section. To navigate back within a protocol use the section tabs. Left Click to on sections tabs to navigate through protocol

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

10. Two ways to Create New Protocol

11. Option 1: Creating a New Protocol Through the e-IRB System 1. 2. 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. 3. 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.

12. Filling out the Protocol on the e-IRB System 1.Tabs 2. Title/General Navigate to each section tab, and fill out the all sections. Enter the protocol’s title. Generally, IRB protocols are approved up to 365 days from the approval date. However, per IRB this may vary depending on the type of study being conducted. First, select “Title/General” tab.

13. Filling out the Protocol on the e-IRB System (Cont.) 3. Personnel To assign roles for PIs & co-PIs (other investigators) click the edit selection box. This will open a new pop-up window.

14. Filling out the Protocol on the e-IRB System (Cont.) 4.CITI Training 5. All other tabs Navigate to each section and complete each entry, excluding Workflow History.

15. Option 2: Uploading a Protocol as a MS Word Document on the e-IRB • NOTE: This method is only available for users that were registered with the IRB before October 2014. Please contact our office for further instructions.

16. Attaching Supporting Protocol Documents Upload supporting documents within the Protocol Screen, in each specific section tab. 1.Attachements Icon 2. Attachments Pop-up Window • Pertinent support documents such as: proof of additional training, special permissions, recruitment material, consent forms and assent forms, and any other supportive records. Try your best to correlate the supporting upload with the related section tab. Make sure to click “ ” • after you have selected the document. When you are ready to exit the window, click “ . ”

17. Protocol Form Checklist Prior to submitting the protocol use the checklistprovided in the section tab Instructions / Checklist, to ensure your protocol is complete.

18. Signing a Protocol Completed draft protocols must be signed by all investigators prior to submittal to the IRB for review. • Remember: • Popup blockers will interfere with the functionality of the e-IRB system. If this does occur, make sure to set the pop-up blocked to “Always Allow Pop-Ups from this site.”

19. Signing Protocol Electronically 1. 2. Right click on the protocol title of the protocol that is highlighted in grey (not the purple!), then select Signatures

20. Is Your Protocol Ready to be Submitted? • 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 to be ready for submittal– always verify with your research team before submittal.

21. Submitting Protocol for Admin. Review  The IRB Office performs an administrative review to satisfy regulatory requirements and clarify any points before sending the protocol to an IRB member to review.  2. 1. Right Click on protocol, then select Administrative Review.

22. Protocol Status Change: To Administrative Review • After the protocol was sent to “Administrative Review,” the PI should then notify the IRB office that the protocol’s status has been changed. This notification should be sent via email to irb@csupomona.edu . • When it is time for the PI to respond to the review the document state will indicate “For Revision.”

23. Protocol Status Change: Admin. Review to Revision Once you have received an email stating that your protocol is ready for revising, log onto the e-IRB and address the comments that the reviewer has made. Click here to view slides for the steps to changing the protocol’s state after revisions have been made. To revise the protocol, check-out the protocol. Be sure that the IRBP Document State says “For Revision.”

24. Check-in | Check-Out Protocol • The e-IRB introduces the concept of checking in or out a protocol. • Protocol Check-Out: A user checking out a protocol is analogous to checking out the sole copy of a library book, i.e. only one PI 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. • It is 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. • When a new protocol is created the author is automatically given check-out privileges to the protocol. • After selecting “Check-Out Document” the icon will display next to the protocol in the Files & Documents screen. 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.”

25. Check-in | Check-Out Protocol (Cont.) Protocol Check-In: Checking in a protocol allows for other users within the research team to edit the document should they it check-out. • 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. 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.

26. 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’s check in-out statuses. Therefore it is suggested, that research teams develop their own standard operating procedures for checking in and out.

27. Revising a Protocol Sometimes the first draft submitted for administrative review will need to be revised by the PI. If this is the case, PI’s must use the Check-In and Check-Out system to make the appropriate revisions.

28. Viewing and Responding to Comments 3. To respond, simply click on the comment and enter your respond in the “Response” box. To save your response click “Respond.” 1. Click on the “Review” option from the protocol form. 2. This window will pop-up and under each or some tabs you will find comments made by the admin reviewer of designated IRB reviewer (DIR). Note: Make sure that you make the appropriate changes indicated my the reviewers comments to your protocol in BOLD or Red.

29. Approved Protocol 2. Finding the Approval Memo on the E-IRB Portal: • Email Notification: • The investigators will receive an email when their protocol has been e-signed by the IRB chair and approved. Right click on the paper clip . On the drop down menu select edit attachment. Be sure that the paper clip you are selecting is the file not the document (file is the pink bar). This window will pop-up and from here you can select the file containing the approval memo to be printed. The header should say:

30. Thank you! Thank you for your patience and hard work! Please share suggestions to improving this training guide. The eIRB looks formidable at first, but it will make sense. Some of its best features are: -Automatic notices when your protocol is approaching expiration. - Accessibility on mobile devices. - Real-time updates about the protocol state. Once again, Thank you!