roche/genentech practical working guide … · information requested by roche/genentech; click the...

ROCHE/GENENTECH

PRACTICAL WORKING GUIDE FOR

REQUESTORS

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ContentsI. INTRODUCTION............................................................................................................................. 3

II. HOW TO REGISTER AND LOG‐IN ................................................................................................... 3

III. HOW TO SUBMIT AN APPLICATION .............................................................................................. 8

IV. HOW TO PROVIDE ADDITIONAL STUDY INFORMATION ............................................................. 24

V. HOW TO PROVIDE SYNOPSIS INFORMATION ............................................................................. 25

VI. HOW TO PROVIDE PROTOCOL INFORMATION ........................................................................... 28

VII. TASK LIST & ALL MY APPLICATIONS ............................................................................................ 29

VIII. FREQUENTLY ASKED QUESTIONS (FAQS) ................................................................................... 30

1. HOW CAN I GET HELP? ............................................................................................................... 30

2. WHAT IF I CAN’T LOGIN? ............................................................................................................ 31

3. WHAT IF I WANT TO ADD MORE INFORMATION AFTER I CLICK SUBMIT? ................................. 33

4. HOW LONG DOES MY SESSION LAST IN THE SYSTEM?............................................................... 33

5. HOW DO I PRINT MY SUBMITTED APPLICATON? ....................................................................... 34

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I. INTRODUCTION

The purpose of this guide is to provide guidance to external requestors applying online for support of externally sponsored scientific research through the Visiontracker system.

II. HOW TO REGISTER AND LOG‐IN

To register and receive a User ID and password for the Visiontracker system, begin by accessing the appropriate web link:

Web link:

HTTPS://ROCHE.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH

OR

HTTPS://GENENTECH.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH

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EXTERNAL REQUESTORS – REGISTER FOR USER ID AND PASSWORD

If you are an External Requestor, please register for a User ID and Password, using the details below. Please note the instructions for registration through both links are the same.

1. Click the Need a User ID link.

2. Complete the Registration form. Required fields are marked with an * [asterisk].

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3. Click OK when complete.

4. Watch for the confirmation box shown below, which indicates a successful registration.

LOGIN WITH USER ID AND PASSWORD

An email with your User ID will be sent to the email address provided during registration. If the message is not received in 20 minutes, search your Junk E‐mail folder, in case it was classified as junk mail.

A second email will be sent containing a temporary password.

1. Log in to the Visiontracker website using the new User ID and the temporary password.

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Note: Notice the Forgot Password link; if you require a new password, click this link and follow

the on‐screen instructions.

The temporary password is designed to work only once. You must create a new password prior to logging in again. Follow the on‐screen instructions.

Tip: If a password does not meet the security requirements, the system will provide

messages to guide you.

The following screen will appear after you have successfully changed your password.

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III. HOW TO SUBMIT AN APPLICATION

1. Log in to the Visiontracker system. From the Task List tab click on New Study.

2. You will be presented with the following screen

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3. Review the How to Apply document – to access the document click on the How to Apply link

Once you have read the document, and providing you agree with the contents, tick the Read and Acknowledge box and click OK.

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4. You will now be asked to select your Study Type

The options available to you are:

Study Type: Interventional

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MAIN NAVIGATION TABS

The main navigation tabs display at the top of the screen of the new application.

To begin, fill in the required information on the Main tab.

All required fields are marked with an * [asterisk]. Fill in the relevant details of your concept; each tab contains required fields.

To switch from one tab to another, click on the intended tab. You may also click the Next Tab link at the bottom of the page to progress to the next tab in the series.

*Tip: For more guidance on the type of information to be added to each section in all tabs, click on

the field label (ie: Concept Title) to show the tool tip.

‘MAIN’ TAB

The Main request tab contains information pertaining to the top level of information of the Application and also the Requestor. A sample screen shot is shown below Note: some selections will automatically add or remove fields accordingly, these additional fields are always *required

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ATTACH THE REQUIRED CV

A required attachment on the Main tab is the CV of the Investigator. To attach this CV, follow the steps below. Other attachments may be needed during the review process

1. To begin, click on the paperclip icon next to the required CV label (this is located under the Primary Investigator section)

2. A pop‐up window appears; click the Choose File button.

3. Navigate to the appropriate folder on your computer, highlight the file name, then click the

Open

button.

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4. At the next screen, enter a description of the attachment (optional).

5. Wait for the orange prompt that reads Uploading, please wait… to disappear, which indicates that the attachment has successfully uploaded to the server.

6. Click OK.

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ADD THE MEDICAL LICENSE INFORMATION (FOR US PRIMARY INVESTIGATORS ONLY)

All US Primary Investigators will be required to add their Medical License Information to the application

1. Locate the Medical License Information section (located under the Primary Investigator section)

2. Click on the button

3. A pop up window will appear

4. Complete the requested information for License Number, State and Exp Date 5. Click OK

Continue to complete the required information for the Main tab.

SAVE STUDY APPLICATION

1. Enter all required information on the Main Tab,

and then click the Save button.

A Save confirmation displays. It contains a temporary application number. This is the application’s identification number prior to submission.

A new number will be assigned after the completed application has been submitted.

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STUDY CONCEPT TAB

The Study Concept tab should be populated with information relating to the concept of the request.

1. You can enter this information by typing directly into the box available or by clicking on the

button next to each section; this will open a separate window for you to populate

Note: You can paste information directly from another source into the text or pop up box to facilitate the population of this tab

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SUPPORT TAB

You will be requested to complete the following information in relation to the Support you are requesting. You will be asked to complete this information by selecting options from the drop down menus and completing all fields shown.

Note: By choosing YES to questions in the drop down menus, other fields may be shown and/or hidden accordingly.

ATTACHMENTS TAB

Additional Attachments may be required throughout the application process.

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1. Click on the icon

2. Click on the button

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Navigate to the appropriate folder on your computer, highlight the file name, then click the Open

button.

4. Select the Type of file from the drop down menu

5. Add a Description, if required (this is optional)

6. Click

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SUBMIT APPLICATION

Check the progress bar, located at the top of your submission, to ensure all required fields have been completed.

1. The progress bar will indicate if there are any fields still to be completed

2. If there are still fields to complete, click on the

button a. This will display information detailing which fields are

yet to be completed

3. Click on the link to navigate to the required tab, or click on the tab itself

4. Complete the fields as required 5. the application

6. Check the Progress bar again, it should now display as

100% complete

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7. Click the button at the top of the screen.

You will be asked to confirm your submission by clicking on the pop up screen

If the submission is successful, a new number is assigned to the completed application.

Please record this number for future inquires. An acknowledgement confirmation email will also be sent.

Note: After completing all required fields and successfully submitting the application, the application cannot be edited until Roche\Genentech requests additional information.

If you have forgotten to include information, contact Roche\Genentech and follow the steps in FAQ NO. 3.

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HELPFUL HINTS & TIPS

1. To locate previously completed applications click the All My Studies tab.

o You can also check the status of your Application under the Other Information column

2. The Copy My Profile button is used to copy the information of the person who registered into the Primary Researcher section of the application. If this information matches, take advantage of the shortcut

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ADDITIONAL ATTACHMENTS

When completing a request, other types of attachments can be included via the Attachments tab; follow the steps below.

1. Click on the tab.

2. Click the Post New link with the paperclip icon under the Additional Attachments section.

3. A pop‐up window displays; click the Choose File button.

Note: Attachments are limited to 20 megabytes.

4. Navigate to the appropriate folder on your computer, highlight the file name, then click the Open button.

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5. At the next screen, select the type of attachment from the drop‐down menu.

6. Enter a description of the attachment (optional).

7. Click OK.

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IV. HOW TO PROVIDE ADDITIONAL STUDY INFORMATION

A user will be notified via email if additional information is required. The additional information requested will be contained in the email and the requestor will be instructed to log into the system to provide the information.

1. Click the link in the email message and log in to Visiontracker using your User ID and password.

2. From the Task List tab, locate the study requiring additional information.

3. Click the Provide Additional Info Requested link.

This link allows you to edit the application and provide the requested information.

4. Add the information requested by Roche/Genentech; click the button when finished.

This application will no longer be displayed on your Task List after submitting the additional information.

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V. HOW TO PROVIDE SYNOPSIS INFORMATION Once the application has received interest to proceed, the Requestor will receive an email asking them to provide the Full Synopsis Information. Follow the steps below:


2. From the Task List tab, locate the study requiring the Full Proposal Information.

a. Click the Provide Synopsis Information link

The Study Synopsis tab will now be visible

3. Click on the Study Synopsis tab

4. Complete the provided Synopsis Template

a. or if you have your own Synopsis Template, please complete but ensure that it includes the following information:

i. Study Rationale ii. Study Objective iii. Study Design iv. In and exclusion criteria v. Study end points vi. Randomization and Stratification vii. Statistical Methods

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viii. Detailed Schedule of Assessment/Events of all visits ix. Special Protocol Considerations (if any) x. Sample Size xi. IMP and non‐IMP and any comparators xii. Dosage and route of administration for all IMPs (including non‐IMP Comparator)

6. Upload your completed Synopsis

a. Click on the Paperclip icon b. Locate the file to upload

i. Provide a Description for the file (optional) c. Click OK

7. Complete the Study Timelines fields

a. Ensure all fields denoted with a * are completed (these are the required fields)

8. In the Planned Publications section, add information relating to the Outcomes publication that you may be planning on submitting:

a. This can be a concept of a Publication, an Abstract or a full Publication i. Click on the ADD button ii. Locate the file to upload iii. Click OK

9. Click Save to ensure your data is saved

10. Click on the Support tab

11. Complete the fields, as needed a. Note: fields displayed will be determined by other data added to the application b. If you are unable to complete all required fields, click Save to ensure your data is saved

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12. Check if all required fields have been completed by verifying that the Submission Requirements banner is displaying as 100%

a. If this is any less than 100% click on the Show Details button to display which fields need to be completed

b. A list of incomplete fields and their location will be displayed, this list can be hidden again by clicking on the Hide Details button

13. Once all fields are completed on the Study Synopsis and Support sub‐tabs click on the Submit

button

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VI. HOW TO PROVIDE PROTOCOL INFORMATION

Once the application has received interest to proceed, the Requestor will receive an email asking them to provide further information relating to the Protocol Information. Follow the steps below:


2. From the Task List tab, locate the study requiring the Full Protocol Information.

a. Click the Provide Additional Information link

3. The Protocol tab will now be available

4. Attach your Protocol document by clicking on the paperclip icon 5. On the New Attachment window select the Choose File button

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6. Locate the file to upload 7. Click OPEN to attach the file to your application 8. Click OK to close the New Attachment window

9. Complete the Regulatory Information if you require your Study to be registered locally

a. You will need to add the following information to the system: i. Clinical Trial Registry Number ii. IND/EUDRACT Number iii. NCT Number

10. Once the information has been added to the system click on the to resubmit your application to Roche/Genentech.

VII. TASK LIST & ALL MY APPLICATIONS

It is possible to access Applications that require immediate attention, and your previously submitted or

ongoing applications, using the Task List and All My Studies tabs.

1. Log in to Visiontracker via the website below using your User ID and password: HTTPS://ROCHE.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH or HTTPS://GENENTECH.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH

2. The Task List will be visible and will list those Applications that require your immediate attention

3. You will notice that your Applications are listed under headers to assist you perform your

actions

4. To access the full list of previously saved or submitted Applications click on the All My Studies

tab

5. To access your Application (in either tab) select either the Tracking Number or the Action listed in the Action column

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VIII. FREQUENTLY ASKED QUESTIONS (FAQS)

1. HOW CAN I GET HELP?

To receive technical support while using Visiontracker, contact Visiontracker Help Desk using the directions below.

1. Access the web link:

HTTPS://ROCHE.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH or HTTPS://GENENTECH.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH

2. Select the Customer Support link located on the left hand side of the screen

3. An email should open

a. If an email does not open automatically, send a request to [email protected]

4. Add your request to the body of the email

5. Send the email to Support

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2. WHAT IF I CAN’T LOGIN?

Double‐check that you have entered your user ID entered correctly.

To request confirmation of your User ID:



7. Select the Customer Support link located on the left hand side of the screen

8. An email should open

a. If an email does not open automatically, send a request to [email protected]

9. Add your request to the body of the email

a. Ensure you specify that you are attempting to access the Roche/Genentech Visiontracker system

10. Send the email to Support

To reset your Password:



2. Enter your User ID into the User ID field

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3. Click on the Forgot Password? link

4. A pop up message will appear

5. Click YES to proceed

The system will send a temporary, one‐time‐use password via email. After you have received your new password, you can log in and you will be required to create a new password. You can then log in with the new password.

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3. WHAT IF I WANT TO ADD MORE INFORMATION AFTER I CLICK SUBMIT?

Unfortunately, you cannot edit it any further after you have submitted the application. The requestor would need to follow the instructions provided in FAQ 3 to contact Roche/Genentech

If Roche/Genentech requests additional information from you, the application will be re‐opened to allow you to add information.

4. HOW LONG DOES MY SESSION LAST IN THE SYSTEM?

Your web session will time out after 60 minutes and you will be prompted to re‐enter your User ID and Password information. Like many other Web applications, this time limit exists for security purposes.

If using Internet Explorer, you might try refreshing the browser memory. However, if you left the browser window open for more than 60 minutes with an incomplete study proposal:

1. Press F5, then click the Logout button in the left column.

2. Exit out of the browser, completely shutting it down.

3. Open Internet Explorer again and log in to the web link.

4. Press F5 and see if your data is recovered.

We recommend that Investigators save their work often to avoid this issue. When stepping away for a while, investigators should log off the system rather than leave the browser window open.

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5. HOW DO I PRINT MY SUBMITTED APPLICATON?

1. Log in to the Visiontracker system using your User ID and password.

HTTPS://ROCHE.ENVISIONPHARMA.COM/VT_ROCHE_GENENTECH

or

HTTPS://GENETECH.ENVISIONPHARMA.CM/VT_ROCHE_GENENTECH

2. Click on the All My Studies tab.

3. Click on the Tracking Number of the study you wish to print.

4. This will bring you to the submission. Click the print icon located in the top right corner.

5. A PDF file is automatically created for you to print or save.

6. Some internet browsers automatically open the file.

If that does not happen, you may need to locate the PDF file named Grant Detail Report in your download folder.

You may see a security warning; if so, click Allow for permission to open the file.

7. To print, Open the Grant Detail Report file.

8. When the file opens, click the File menu and then click Print.

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