IRB Committee Member

eIRB

IRB Committee Member

User Manual

Edition 1, November 12, 2007

Click Commerce, Inc.

Table of Contents

Welcome to eIRB

eIRB Requirements

eIRB Access

Obtaining an Account

What can eIRB Do?

Information for Committee Members

Steps to Review an IRB Submission Where You Are a Primary or Secondary Reviewer

Welcome to eIRB

eIRB stands for Electronic Institutional Review Board. The purpose of the eIRBsystem is to provide a more efficient process of submitting, approving, tracking, and management of IRB study submissions.

eIRB Requirements

To use eIRB, you are required to have one of the following Internet browsers:

Microsoft Internet Explorer 5.0 or higher (preferred)
AOL 5.0 or higher
Netscape 4.79 or higher
Mozilla 1.6 or higher
Opera 7.10 or higher

For all Internet browsers, you must have client-side JavaScript enabled. To use the document upload feature and some reporting features, you may be asked to allow Java applets or Active X to run in your browser. You will need to accept the certificate to upload files. ClickCommerce/Webridge Incorporated certifies all items. The eIRB website was designed using a screen resolution of 1024 x 768. It is suggested you use this screen resolution for the optimal display of the eIRB website.

eIRB Access

The website is available via any Internet connection made by a supported browser. eIRB will be accessible 24 hours a day, 7 days a week.

Obtaining an Account

Investigators and study personnel may self-register to obtain account by following the directions below.

Goto Self Registrationby clicking on the Registration link onthe righthand side of the page.Complete the required fields on the form and click register. Upon completion, you will be returned to the home page of the site.

Please note that all fields with a red asterisk are mandatory; and you must submit a valid email address to be granted access to the system. After your account request has been submitted, you will receive an email with account information. Please allow at least one business day for account creation.

IRB will handle content and general usage questions. The IRB can be reached at xxx-xxx-xxxx. For technical problems, contact the help desk at xxx-xxx-xxxx.

Once you have an account, you can navigate to the eIRB site and click the Login link in the top right corner to login.

What can eIRB Do?

Using the new eIRB website, you can:

Create and edit an electronic application for IRB studies
Add other investigators and study personnel to assist in editing the study application.
Prepare the study application via “SmartForms” that present only those sections that are applicable and relevant to your study.
Attach scanned or electronic documents to the study.
Print out the application in a printer-friendly version.
Validate the application before submission to catch common mistakes and reduce the number of changes required after submission.
Submit a single application electronically to the IRB.
Track the progress of the application as it is automatically routed for review and signoff to the appropriate organizations (i.e., ancillary approvers and department heads) before being received by the IRB.
Receive email notifications anytime a reviewer sends the application back for requested changes.
Receive the approval letter via email once the study is approved. A copy of the approval letter and approved consent forms will be posted online with the study and available for download at anytime.
View a time stamped log of all changes made to the application and any correspondence sent between the study team and the IRB.

Information for Committee Members

Personal Folder Elements

Top Navigator Bar

Your Name: Access/Modify personal contact information. Change password
My Home: Your personal folder (this page)
Logoff: Ends your eIRB session
My User Roles: Only available if you have more than one user role. Switch to a different user role.
My Committees: Quick link to the IRB committees you serve on.

Tabbed Area

My Inbox: Displays all IRB submissions that you have been assigned to review for the next committee meetings.

My Reviews: Lists all of IRB submissions in the system where you have been assigned as primary or designated reviewer.
Upcoming Meetings: Lists upcoming committee meetings.

Study Workspace

CurrentState: Indicates where the study is in the IRB review/approval process.
View Study: Opens the application smart forms in read-only mode, but allows the committee member to submit reviewer notes.
Printer-Friendly Version: Opens page displaying all applicable sections of the application in a version that will easily print on most printers.
My Activities: Displays all available actions you can do at this point
Submit XXXXX Review: Records your review. Comments may be typed on the screen or uploaded in a MS Word document. You can make multiple edits.
Log Comment: Writes a comment to the study file. All IRB members.

• History: Log of all actions performed on this study proposal

• Attachments: Quick links to common documents attached to the application.

• Pre Review Status: Indicates status of all required division/department approvals

Steps to Review an IRB Submission Where You Are a Primary or Secondary Reviewer

Login with your username and password.
Open the study from My Inboxby clicking on the name.
In the study workspace, click the View Studyicon to open the smart form application. OR - Click the Printer Friendly Versionicon to open the entire application in a printable version.
Review the study application and attached documents.
Record any comments for you review using the reviewer comments function.
Exit the application to return to the study workspace.
Click the Submit XXXXX Reviewactivity.
Type or paste your review into the comments text box. (Alternatively, you may attach a document in the Attachments section.
Click the OK button to submit your review.