17
Investigator Quick Reference Guide
Investigator Quick Reference Guide
page 2
Contents INVESTIGATOR ACTIVITIES QUICK REFERENCE GUIDE ................................................... 1
I. INTRODUCTION ................................................................................................................................... 3
II. HOW TO REGISTER AND LOG-IN ......................................................................................................... 4
III. HOW TO SUBMIT AN APPLICATION .................................................................................................... 7
IV. HOW TO ACCESS A SAVED PROPOSAL .............................................................................................. 10
V. HOW TO PROVIDE ADDITIONAL PROPOSAL INFORMATION ............................................................. 10
VI. HOW TO SUBMIT STUDY STATUS UPDATES ...................................................................................... 11
VII. FREQUENTLY ASKED QUESTIONS - FAQS .......................................................................................... 14
HOW CAN I GET HELP? ............................................................................................................................ 14
WHAT IF I CAN’T LOGIN? ......................................................................................................................... 14
WHAT IF I HAVE A QUESTION ABOUT MY SUBMISSION? ........................................................................ 15
WHAT IF I WANT TO ADD MORE INFORMATION AFTER I CLICK SUBMIT? .............................................. 15
HOW LONG DOES MY VISIONTRACKER WEB SESSION LAST? .................................................................. 16
HOW DO I PRINT MY SUBMITTED APPLICATON? .................................................................................... 16
page 3
I. INTRODUCTION The purpose of this guide is to provide guidance to academic Investigators applying online for support of Preclinical Research Collaborations
APPLICATION INSTRUCTIONS: Investigators interested in establishing a preclinical collaboration must submit an application online outlining their research plans. The application will be evaluated within two to three weeks of submitting your proposal, depending upon the date received (proposals are reviewed on a monthly basis). You may check the status of your proposal at any time by logging into your account. A complete review of your request may take up to 4 months to complete depending upon the types of materials requested and the number of review cycles required for approval. You will be notified when your proposal is approved and the process to draft your legal agreement has been initiated. Once Regeneron and your Institution have signed the legal agreement we will initiate the shipping process; if you are receiving mice from another investigator, you may reach out to this investigator to make arrangements at this time.
If you need to make significant changes to your approved research plans, including the addition of new/different reagents covered under your agreement, you must submit a new application that will need be approved by Regeneron. If you would like additional reagent to continue your studies or would like to extend the term of your agreement, please contact us at [email protected]
ONLINE PRECLINICAL COLLABORATION PROPOSAL APPLICATION An application for research support may be initiated by using the Regeneron Preclinical Research Collaborations portal for online submissions in the Visiontracker™ (VT) system.
URL-address:
HTTPS://REGENERON.ENVISIONPHARMA.COM/VT_REGENERON/
Registering in Visiontracker
Investigators must register/create an account in Visiontracker at the time of first use. This account may be used for all PRPA applications submitted by the investigator.
Detailed instructions regarding the online PRPA application process can be found online in the “Application Instructions” section of web portal.
page 4
RESEARCHER RESPONSIBILITIES AND REQUIREMENTS
As per your legal agreement, we request periodic study updates as well as final reports upon completion of your proposals. In addition, all manuscripts must be sent to Regeneron for review before publication.
II. HOW TO REGISTER AND LOG-IN
To register and receive a User ID and password for the Visiontracker PRPA system, begin by accessing the web portal:
Web link:
HTTPS://REGENERON.ENVISIONPHARMA.COM/VT_REGENERON
REGISTER TO RECEIVE A USER ID AND PASSWORD 1. External Investigators, click the link as shown in the image below.
2. Complete the Registration form. Required fields are marked with an * (asterisk).
page 5
3. Click OK when complete.
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, just in case it was classified as junk mail.
A second email will be sent containing a temporary password.
1. Log in using the new User ID and the temporary password.
NOTE: Notice the Forgot Password link; in the future, if you require a new password, click this link and follow the procedure below.
page 6
2. The temporary password works only once. You must create a new password prior to logging again. Follow the on-screen instructions.
If a password does not meet the system’s security requirements, the system will provide messages to guide you.
page 7
3. The following screen will appear after you have successfully created a new password.
III. HOW TO SUBMIT AN APPLICATION Log in to the Visiontracker system. From the Task List tab click on New Proposal.
1. Review the NONCONFIDENTIALITY NOTCE and select to confirm that “I acknowledge, agree and accept” at the bottom of the text and then click OK.
MAIN NAVIGATION TABS The main navigation tabs will display at the top of the screen. Begin with the Main tab and complete all the fields under each tab.
Each tab contains required fields. All required files are marked with an * (asterisk).
• Main • Study Details • Attachments
page 8
To switch from one tab to another, click on the actual tab.
SAVE PROPOSAL APPLICATION
2. prEnter a Research Title and then click the Save button.
• A save confirmation displays. It contains a temporary application number. This is the proposal application’s identification number prior to submission.
• A new number will be assigned after the completed application has been submitted
SUBMIT APPLICATION 3. When complete, click the Submit button.
• When 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.
• Any red text indicates items that must be completed before the system will accept the proposal application.
• Click on each main tab and search for red colored fields. These required fields must be completed in order for the system to accept the proposal application.
• Once corrected, click the Submit button again.
TIPS • Click Copy buttons to automatically copy information entered during registration (such
as email address, address, etc.) into the Sponsor Investigator section on the Main tab and the Legal/Contracting Contact Information for Primary Site on the Support tab.
• Click Save every 15 minutes to prevent loss of any data entered.
page 9
• Submitted applications cannot be edited; be sure your proposasl application is complete and accurate before submitting.
• The Submit button identifies any missing required fields; the labels will change to red text.
• Click Save to hide the red text.
• Caution – do not click Submit until you are ready to submit because you will not be able to make any changes if all required fields are complete. You cannot edit the proposal application after it has been submitted.
ATTACHMENTS
Additional Supporting Materials
To attach additional supporting materials or protocol documents to your original submission package, begin by clicking on the Attachments tab.
1. Click on the Attachments tab.
2. Click on the paperclip icon.
3. A pop-up window displays; click the Choose File button.
4. Navigate to the appropriate folder on your computer, click to highlight the file name, then click the Open button.
5. At the next screen, enter a description of the attachment if you wish.
6. Click OK.
7. Repeat this process until all of your Additional Supporting Materials have been added.
page 10
IV. HOW TO ACCESS A SAVED OR SUBMITTED PROPOSAL 1. Locate previously saved applications by clicking on the tab to the left
named All My Proposals. 2. Click on “View Propsal” to view your saved proposal to continue working
on your proposal. 3. To access submitted proposals, click on the All My Proposals tab. 4. The Copy Proposal button can be used to copy a previously submitted proposal application.
V. HOW TO PROVIDE ADDITIONAL PROPOSAL INFORMATION You will be notified via email if additional information is required for your submission.
1. Click the link in the email message and log in.
2. From the Task List tab, locate the proposal requiring additional information.
3. Click the Provide Additional Information link.
• This link allows you to edit the application.
4. Add the requested information and click the Submit button when finished.
• This proposal application disappears from your Task List after submitting it.
page 11
VI. HOW TO SUBMIT STUDY STATUS UPDATES Active proposals require updates periodically. You will be notified via email when a study status update is required. Click the link in the email message and log in.
The Task List will display this link to allow you to begin the study status update.
1. From the Task List tab, click the View or Add Status Updates link.
2. The Study Status Update section should open, if not click on the Study Status Update tab
Update Shipment Tracking Information
As part of the Study Status Updates, you will be required to confirm receipt of your shipment. The system will indicate that you need to complete this information when the Shipment
Tracking section is populated.
1. Click on the button, the Shipment Tracking information box will open
2. Click the Calendar icon 3. Select the Materials Received date from the calendar pop up
4. Once selected click
page 12
Providing Progress Updates
1. To provide a Progress Update click on the button next to that section 2. The Progress Updates box will open
3. Add any Progress Updates to the comments box 4. To add Supporting Attachments click on
the paperclip icon , the New Attachment window will open
5. Click Choose File 6. Locate your required file
7. Click OPEN
8. Specify the TYPE by choosing from the drop down menu 9. Add text as needed to the Description field 10. Click OK 11. Click OK on the Progress Updates box to close it 12. After updates to this section are complete click OK 13. SAVE your proposal
Providing Publication Updates
page 13
1. To provide a Progress Update click on the button next to that section 2. The Publication Updates box will open
3. The *Entry Date should be auto populated with today’s date
4. Select the Publication Type from the drop down menu
5. Manually complete the Publication Title
6. Select the Primary Publication from the drop down menu
7. Manually add the Journal or Meeting Name
8. Update the Publication Review Needed by Date, Anticipated Publication Date and Actual
Publication Date fields by clicking on the calendar icon next to each field and select your date as appropriate
9. To add a document at this stage click on the paperclip icon ( )
10. Click , locate your file and click
11. Add text (if appropriate) to the Description field then click
12. Click again
13. Click the Submit button to complete the study status update and send notification to the company.
page 14
VII. FREQUENTLY ASKED QUESTIONS - FAQS
1. HOW CAN I GET HELP?
A) To receive technical support while using the Visiontracker system contact the Envision Technology Solutions (ETS) help desk. ETS provides technical support for the Visiontracker application program: 1. Click on the Contact Us link on the left side of the web page. 2. Select Technical Support from the Address to field.
3. Select a Subject from the drop-down menu. 4. Select a Related to item from the drop-down menu. 5. Type your Message into the box. 6. To attach a screen shot or other documentation click the Browse button, navigate to
the file location, click on the file name, and then click the Open button. 7. Click Send.
B) Email the ETS help desk: [email protected]
C) Call the ETS help desk: • US Hotline: +1 860 266 4944 (9 AM – 4 PM EST) • Europe Hotline: +44 1403 322 075 (9 AM – 4 PM GMT)
2. WHAT IF I CAN’T LOGIN?
Double-check that you have your user ID entered correctly into the User ID field.
If you have forgotten your password, click on the "Forgot Password" link. The system will send a temporary, one-time-use password. After you have received your new password and login,
page 15
you will be required to create a new password. Then log in with the new password.
If you do not recall your User ID, email the Envision Technical Solutions (ETS) help desk at [email protected]
Or call the ETS help desk: • US Hotline: +1 860 266 4944 (9 AM – 4 PM EST) • Europe Hotline: +44 1403 322 075 (9 AM – 4 PM GMT)
3. WHAT IF I HAVE A QUESTION ABOUT MY SUBMISSION?
Please contact [email protected] for any questions regarding the submission content.
4. WHAT IF I WANT TO ADD MORE INFORMATION AFTER I CLICK SUBMIT?
Unfortunately, after you have submitted the proposal application you cannot edit it any further.
If the company requests additional information from you, the proposal application will open-up to allow you to add more information into it.
You may send the company a message explaining why you need to make changes to the proposal application that you have already submitted.
1. Click on the Contact Us link on the left side of the web page. 2. From the Address to field select Contact Regeneron
3. Select a Subject from the drop-down menu. 4. Select a Related to item from the drop-down menu. 5. Type your Message into the box. 6. To attach a screen shot or other documentation click the Browse button, navigate to
the file location, click on the file name, and then click the Open button.
page 16
7. Click Send.
5. HOW LONG DOES MY VISIONTRACKER WEB SESSION LAST?
Your Visiontracker Web session will time out after 60 minutes (please note: navigating from tab to tab, successfully saving/submitting your proposal and entering items into a “one to many” field will all reset this timer), and you will be prompted to reenter your Username 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. If you left your browser window open for more than 60 minutes with an incomplete 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 were recovered.
It is recommended 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.
6. HOW DO I PRINT MY SUBMITTED APPLICATON?
Here is one way to print your submitted application.
1. Log in to the Visiontracker system. 2. Click on the All My Proposals tab. 3. Click on the Tracking Number of the proposal you wish to print.
4. Click on the print icon, located in the top right corner.
5. An Adobe PDF file is automatically created for you to print or save. 6. To print, click the Open button.
page 17
7. If you receive a security warning, click Allow to open the file.
8. When the file opens, click the File menu and then click Print. The proposal application will print to the printer previously configured as the default printer.
