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Boehringer Ingelheim IIS Web-Portal Application Submission Reference Guide QUICK REFERENCE GUIDE: Submitting an IIS synopsis is the initial stage in the Boehringer Ingelheim (hereinafter, “BI”) process. This Quick Reference Guide contains step by step instructions on how to submit the IIS synopsis.- BI IIS WEB-PORTAL The BI IIS web-portal (Vision Tracker TM ) is used for sponsor investigators to submit their IIS applications, and for BI to perform reviews, approvals and tracking of IIS tasks and associated documents related to these studies. HOW TO CREATE A USER ACCOUNT AND LOG ON 1. In an open web browser, please navigate to the IIS web-portal by typing the following URL into the address box and pressing “Enter” – https://bi.envisionpharma.com/vt_bi_iis/ 2. Welcome to the BI IIS web portal log in page. If you do not have an account, please self-register by clicking the link under “Need a User ID?” If you already have an account, skip to #6 3. The registration information window will display. Please complete all required fields (marked with asterisk) in this window and then click “OK”. 4. A message will appear on your screen confirming that you have successfully submitted your registration request. Click “OK” 5. In separate emails, your username and temporary password will be sent to the email address you entered during registration.

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Boehringer Ingelheim IIS Web-Portal Application Submission Reference Guide

QUICK REFERENCE GUIDE:

Submitting an IIS synopsis is the initial stage in the Boehringer Ingelheim (hereinafter, “BI”) process. This Quick Reference Guide contains step by step instructions on how to submit the IIS synopsis.- BI IIS WEB-PORTAL The BI IIS web-portal (Vision TrackerTM) is used for sponsor investigators to submit their IIS applications, and for BI to perform reviews, approvals and tracking of IIS tasks and associated documents related to these studies. HOW TO CREATE A USER ACCOUNT AND LOG ON

1. In an open web browser, please navigate to the IIS web-portal by typing the following URL into the address box and pressing “Enter” – https://bi.envisionpharma.com/vt_bi_iis/

2. Welcome to the BI IIS web portal log in page. If you do not have an account, please self-register by clicking the link under “Need a User ID?” If you already have an account, skip to #6

3. The registration information window will display. Please complete all required fields

(marked with asterisk) in this window and then click “OK”.

4. A message will appear on your screen confirming that you have successfully submitted your registration request. Click “OK”

5. In separate emails, your username and temporary password will be sent to the

email address you entered during registration.

Boehringer Ingelheim IIS Web-Portal Application Submission Reference Guide

6. Log onto the IIS web portal using your user ID and temporary password.

7. Your temporary password must be reset upon first entry into the web-portal. Passwords are case-sensitive and require at least one uppercase alpha character and at least one numeric character, with minimum of 8 characters. Once you have entered and confirmed your new password, click “OK”.

HOW TO SUBMIT A NEW IIS APPLICATION

1. The top left corner of the home page contains a menu with two options – “Task List” and “All My Applications”. To submit a new IIS application, please make sure “Task List” is selected, then click on the link – “New Application”. If you have previously submitted an IIS application to BI through the web-portal or you have recently started an application and would like to now finish it, you can locate these applications under “All My Applications”.

2. A new window will open to display the IIS portal Terms and Conditions and Online

Privacy Policy. Click on each link to read the related documents. After reading, click the checkbox to indicate that you acknowledge the terms. Then click “OK”

3. This will bring you the Synopsis tab. Please complete all required fields with

enough details to allow a review committee to be able to accurately assess your study. You may save your work by clicking “Save” and come back later to finish. Please note: Once you begin submission of your proposal, please save your work frequently. For security purposes, the logon time is limited to 90 minutes. If you have started the proposal submission process and wish to complete it at a later date, be sure to save before exiting the system.

To provide assistance in completing your application, each field within the synopsis provides help text defining the field requirements. To view the text, hover your mouse pointer over the field label or click on the field label to pin the text on left side of application.

Boehringer Ingelheim IIS Web-Portal Application Submission Reference Guide

Once you have completed all of the required fields denoted by asterisks, please click the “Submit” button. Please note the “Save” and “Submit” buttons can be found both at the top and bottom on the page.

4. You will receive a message to confirm submission of your application. Click “OK” to continue. A message will follow that confirms your application was successfully submitted, and an IIS tracking number will be assigned. Please keep note of that tracking number for the duration of the application process. Click “Close” to close the message, or “Home” to return to the home page.

HOW TO LOG OUT OF THE IIS WEB PORTAL To log out of the IIS web portal, click the Logout button located on menu on the left side of the screen

The Medical IIS Office within Medical Education & Research Grants department should be the primary point of contact for all questions pertaining to this guide. For assistance please send request to the IIS service mailbox at [email protected].