External User Guide
Table of Contents INTRODUCTION GETTING STARTED Mission Statement Commitment to Research G Vision Investigator/Sponsor Responsibilities Visiontracker Web Portal Registration New User Log in Forgot Password Landing Page Task List + All My Applications Profile Additional Support NEW APPLICATION Start a New Application Legal Acknowledgments Priming Questions Navigating the Application Main Tab Medical License Information Key Study Personnel Additional Sites Study Information Tab Planned Publication Support Tab Budget Legal/Contracting/Payee Attachments Tab Submitting an Application POST SUBMISSION Request for Additional Information Application Process Flow Review Process Application Status Application Decision 2
Introduction 3
Introduction Mission Statement Gilead actively supports investigator sponsored research (ISR) conducted by third parties on Gilead's marketed products or within therapeutic areas of interest to the company. This research can provide valuable information regarding the safety, efficacy, pharmacology, and tolerability of Gilead's products and supplement the comprehensive data generated in registration studies. Collaboration Innovation Integrity 4
Introduction Commitment to Research At Gilead we are inspired by the opportunity to address unmet medical needs for patients living with life threatening diseases around the world. Gilead provides grants primarily in our therapeutic areas of expertise and based on the scientific merit of the proposal. The research must be intended to contribute knowledge to the medical community. The budget must be reasonable and appropriate for the proposed work. In considering applications for support, Gilead will also consider the expertise of the proposed principal investigator and any sub investigators, including their experience in the relevant therapeutic area, demonstrated ability to successfully conduct clinical trials, and available resources. 5
Introduction G Vision New ISR Proposal Management System The new system offers additional transparency and ensures compliance throughout the ISR proposal management process. Local Project Manager Research Scientist Global Project Manager G Vision will allow us to manage ISRs more efficiently by streamlining submission through a web portal and then managing the end to end business process of reviews and approvals. The system offers the following: Reviewer Innovative technology for an upgraded proposal request process Improved and automated internal and external communication capabilities Increased reporting options. 6
Introduction Sponsor/Investigator Responsibilities Sponsor Responsibilities As the sponsor of the study, the investigator and/or institution must ensure that the study is conducted in accordance with the provisions of the ICH GCP Guidelines and all applicable local and regulatory requirements. Investigator Responsibilities The Principal Investigator must assume all regulatory responsibilities including, but not limited to, IRB/IEC approvals, regulatory approvals, and any and all reporting obligations to local Regulatory Authorities. 7
Getting Started 8
Getting Started Visiontracker Web Portal User ID First time users of the Visiontracker applicant web portal will need to register. To create a User ID, click on the link under begin registration process, clicking here. 9
Getting Started Registration New User Registration Information A pop up window will appear, complete the form by filling out each line. Lines with an asterisk (*) are required. Click OK to complete the registration. The new user will receive 2 emails: 1. Confirming registration and User ID 2. Containing a temporary password. 10
Getting Started Log In Log in from G Vision Landing Page enter your User ID, and Password, click Login. 11
Getting Started Forgot Password Forgot Password Use the link below the Password Field on the landing page, click Forgot Password? to obtain or reset your password. The password will be sent to your registered email. Other Problems Contact Customer Support directly from the link on the landing page for any log in issues. 12
Getting Started Landing Page Navigating G Vision Landing Page Click on the links on the left hand side of the Landing Page for company contacts, update profile, or obtain technical support. Additional links can be used to access the Gilead Homepage, FAQ Document, and Practical Working Guide. Logout Change Password Contact Us Update Profile Company Home Page Application Instructions Gilead Privacy Policy Envision Privacy Policy 13
Getting Started Task List + All My Applications Task List The Task List will be empty when you first log in. However, applications that are incomplete but not submitted or submitted applications requiring additional information will display on the Task List. All My Applications All submitted grants that do not have a task to complete will display under this tab. 14
Getting Started Profile Update Your Profile Your user profile can be updated by clicking Update Profile in the top right hand corner or the Update Profile link on the left hand side of the screen. A pop up window will appear containing the current User Details. When the desired changes are made click OK. User Details User Address 15
Getting Started Additional Support Gilead ISR Submission Support Website: http://gilead.com/ Email: phase4approval@gilead.com G Vision Technical Support Email: visiontracker_general_requests@envisionpharmagroup.com Phone Numbers: Helpdesk UK & EU: +44 1403 322095 Helpdesk USA: +1 860 266 4944 Hotline USA: +1 860 266 4944 (9:00 AM 4:00 PM, EST) 16
New Application 17
New Application Start a New Application To begin a new application click the New Application button from the Landing Page. 18
New Application Legal Acknowledgments The New Application window will open asking the user to certify that the submission meets the listed terms and conditions associated with applying and executing an educational grant. Scroll through and read the information, check the box at the bottom acknowledging your review, and click OK. 19
New Application Priming Questions Use the drop down menus in the New Grant Dialog window to select the application type, clinical or non clinical, and the therapeutic area of the project the and click OK. 20
New Application Navigating the Application Move between application tabs using the menu at the top of the screen. The completion status will update as the application is filled out. Applications do not have to be completed all at once. Click Save to return at a later time. A temporary ID will be assigned for applications that are saved. The page will timeout and unsaved data will be lost if no movement occurs for 60 minutes, so please save often. 21
New Application Application Tabs: Main The blue highlighted circle on the tab indicates which section of the application is open, use the + key to navigate to any of the additional tabs. The main tab of the application contains details about the primary researcher and site, along with general information about the proposed study. Key personal and additional site information can also be entered here. 22
New Application Medical License Information Medical license information is required for the US primary researcher. Scroll to medical license information on the main tab, click Add. A new window will open, enter the license number, state, and expiration date and click Ok. 23
New Application Key Study Personnel and Administrative Contacts Scroll to the Additional Personnel and Site Information Section on the main tab. Click Add to open the Key Study and Administrative Contacts window, complete the required information marked with an asterisk(*), including their institution and role, click Ok. Click Add again to add additional personnel. 24
New Application Additional Sites Additional study sites can be added on the main tab. Scroll to the Additional Personnel and Site Information section. Click Add to open the Additional Sites window, complete the required information marked with an asterisk (*), click Ok. Click Add again to add additional personnel. 25
New Application Study Information Tab The blue highlighted circle on the tab indicates which section of the application is open, use the Complete key to navigate the required to any of information the additional the tabs. Study Information Tab. There are fields for the Scientific Basis/Rationale, Hypothesis, The Main Tab Primary of the Objective, application and contains Secondary the required Objective. attestations, general information about the proposed program and details regarding the applicant organization, accrediting provider, and additional medical education partners, if applicable. 26
New Application Study Information Tab It is important to enter the required information about the study enrollment demographics, sites, and treatment regimen for applicable studies. 27
New Application Planned Publication A planned publication is required for submission. Scroll to the bottom Study Information Tab. Click Add to open the Planned Publications window, scroll and complete the required information marked with an asterisk (*), click Ok. Click Add again to add additional publications. 28
New Application Support Tab The Support Tab contains financial and contracting information. Use the drop down menus to select the type of support for this submission and indicate if additional support from other entities is being sought. Data collection is dependent upon the type of support selected. *The Gilead Investigator Sponsored Research program employs a cap of 30% on indirect or overhead costs for submitted proposals. For more information, please speak to a member of the Medical Affairs team or your local Gilead Medical Scientist. T 29
New Application Budget If funding is requested, download the Budget Template from the Support Tab. Instructions for using the template and information regarding the budget requirements are on the first tab on the MS Excel spreadsheet. Use the Standard Budget Template on tab two to complete your study budget. Save your budget and upload the completed template in the Budget area located on the support tab. 30
New Application Legal/Contracting and Payee Information Legal/Contracting and Payee Information can be entered on the Support Tab at this time. However, this information is not required for submission. The Gilead team will send a request when this information is required. 31
New Application Attachments Tab Additional documents can be attached to the submission in the Attachments Tab. Click Post New, choose the file to be updated, select the type, and provide a brief description. Click Ok, the document will then be listed. Repeat to add additional attachments. 32
New Application Submitting an Application Completing The blue highlighted the Application circle on the tab indicates which section of the application is open, use key When to navigate the application to any of the is completed, additional tabs. the Submission Requirements Bar will be at 100%. Click Submit, and then click OK to confirm the submission. The applicant will receive The Main an Tab email of the confirming application submission contains and the a required Grant Tracking attestations, Number. general information about the proposed program and details regarding the applicant organization, accrediting provider, and additional medical education partners, if applicable. 33
Post Submission 34
Post Submission Application Process Flow Preliminary Proposal Review Local Proposal Review Global Proposal Review Decision 35
Post Submission Review Process Applications are reviewed using the elements below: Completeness: Is the submission package complete and does it include enough information for the proposal to be assessed and reviewed? Strategic Alignment: Does the proposal align with current ISR priorities? Duplication: Have the objectives of the proposal been examined and addressed by other studies? Compliance: Whatever the aspect of the proposal, it must adhere to the applicable polices, regulations, and laws. 36
Request For Additional Information Request For Additional Information During the review process, you may receive an email asking for Additional Information, with a link to the G Vision web portal. The request will appear on your Task List the next time you log into G Vision. Click Provide Additional Information to open your application. 37
Request For Additional Information Request For Additional Information Responding to the Request The requested information will appear at the top of the Application. Make the required changes directly in the application and then click Submit.. 38
Post Submission Application Status The application status updates will update automatically in the G Vision system. Applicants can view the status of a submission from the All My Applications Tab. 39
Post Submission Application Decision Applicants will be notified by email when a submission decision has been made. Gilead may choose to approve, decline, or decline and request resubmission. Instructions and contact information will be provided to the applicant in an email notification. 40