USER GUIDE FOR THE VISION TRACKER ONLINE GRANTS MANAGEMENT SYSTEM

Transcription

1 USER GUIDE FOR THE VISION TRACKER ONLINE GRANTS MANAGEMENT SYSTEM Table of Contents I. Getting Started - Registration II. Submitting a Grant Request a. Medical Education b. Charitable c. Investigator Initiated Studies d. Sponsorship e. Membership III. Reconciliations IV. Frequently Asked Questions

2 I. Getting Started Thank you for your interest in Vertex funding! This manual will guide you through how to submit your first application through our Vision Tracker system. We recommend that you save often, and feel free to contact us with any questions or concerns you may have along the way. 1) To begin, navigate to the VisionTracker website (vrtxgrants.com or vrtxiisgrants.com). Please register as a new user if you have never submitted a grant with Vertex. 2) Upon clicking to register as a new user, you will be required to fill in some information about your organization. Note that we do not provide funding to individuals.

3 The address entered will be used as the primary point of contact with the requestor, and will be your log in ID to access the grant request. Upon registration, you will be sent an with a temporary password. Please change your password when you log in for the first time.

4 II. Submitting a Grant Request 1) On the next screen, you can begin your application by clicking the New Grant button. (Note: If you need to update your profile, you may do so from this screen as well). 2) Upon initiation of a new grant request, you will need to consent to the Vertex Terms, and then select which type of grant application you will be submitting.

5 A) Medical Education Grant Request Independent Medical Education grants support CF focused independent programs and/or materials for healthcare professionals that aim to sharpen and expand their skills and knowledge with the goal of improved patient outcomes. Vertex will prioritize medical education that is high-quality, balanced, scientifically rigorous, free from commercial influence or bias, and, compliant with the PhRMA Code, FDA, ACCME, and OIG requirements and other applicable laws. Examples of Programs We Support Symposia Interactive websites Journal supplements i) After choosing Medical Education as the grant type, you will be asked what therapeutic area you are interested in (Cystic Fibrosis being the only therapeutic area we support at this time), as well as whether or not the program is accredited. In addition, you will be asked to confirm that your organization has not provided any promotional services to Vertex within the past 12 months, as that would make you ineligible to receive a medical education grant.

6 ii) At the next step, fill in information on your organization. If the information (address, phone number, etc) is the same as what you filled in during registration, you can use the Copy Profile button to transfer that data into these fields. Note that not all fields will carry over data, so some will still need to be filled in. Any field in the application with an asterisk (*) next to it is required. iii) On the same tab, we ask about other potential sponsors/partners for the activity. If you are requesting funding from other organizations, then the program is multi-sponsored, but if you are only requesting support from Vertex, then it is a single-sponsored program. If funding has been confirmed from another sponsor, please input information on the additional sponsors.

7 iv) To continue to the next section, either click on Program Details on the bottom-right corner, or use the tabs at the top of the screen to navigate to that section. v) The top portion of the Program Details tab is the Program Information. Enter the title, description, and dates of the program. Some important things to note on this section include: Start date the start date of the program must be at least 30 days from the day that the request is being entered to ensure that the review committee has adequate time to provide a thorough review of the application. If the start date is not more than 30 days away, the system will not allow the grant to be submitted The program description should be a brief overview of what type of program is being requested. There is space for an attachment further in the request (on the Attachments tab) where a more detailed description can be uploaded

8 The Primary Audience list is a drop down where the requestor selects, from a list of specialties, who the learning activity is targeted towards. The Audience Description allows the requestor to include secondary audience types as well. vi) If you indicated that the program is accredited (in the initial questions), the following section requires you to select which accrediting body you have certification with. If you select Other, the Describe if Other field will become open for your description. vii) The final section of the Program Details asks for information on how attendees will be recruited, as well as examples of prior experience with similar programs.

9 viii) You can use the bottom-right Activity Details button, or the tabs at the top of the screen to navigate to the next section. ix) The Activity Details tab will ask for information on the proposed activity. To input information on the activity, click the Add button on the right side of the screen. x) This will bring up the Activity Information window, where you can select the type of planned activity.

10 xi) Following this, more information is requested about your activity. xii) If more than one activity is planned, or more than one type of activity is proposed, simply click the button to include more events. xiii) As with the Activity Information, click the Add button to include information on the venue of the planned activity.

11 xiv) Once the information is entered, you can edit it using the Edit button on the right-hand side of the screen. If it is correct, navigate to the Budget tab using the Budget button on the bottom, or the tabs at the top. xv) On the Budget tab, you must first select your local currency, and then fill in amounts for the listed fields. If you have a more detailed budget than the fields allow, you are

12 welcome to upload it as an attachment in the next phase. Please note: The Total Program Budget in Local Currency and % Requesting from Vertex fields will populate automatically when you click the View/Update Calculation link. xvi) Use the Attachments button on the bottom right or the tabs at the top to navigate to the Attachments section. xvii) On the Attachments tab, you will need to upload some required documents. To do so, click on the Paperclip icon, and browse to the file on their computer. If you have

13 additional attachments outside of what is requested, include those in the Additional Attachments section. After an attachment is uploaded, you may edit it by clicking on the pencil icon or delete it by clicking the red X. xviii) Once all required information is entered, click Submit to finish the application. This will bring up a verification window of your grant application number. Make note of this application number as it will serve as your reference number going forward.

14

15 B) Charitable Grant Request Vertex supports certified nonprofit organizations with activities and programs that enhance the following: STEM (Science, Technology, Engineering, Math) initiatives and health education CF advocacy, community groups, academic institutions and medical societies The local community, particularly by supporting organizations that aid underserved or disadvantaged populations i) Upon selecting Charitable Grant as the grant type, you will be asked to choose which charitable objective the grant fulfills. Note that Circle of Care is a special grant type and should only be used if applying to the Circle of Care program. At the next step, fill in information on your organization. If the information (address, phone number, etc) is the same as what you filled in during registration, you can use the Copy Profile button to transfer that data into these fields. Note that not all fields will carry over data, so some will still need to be filled in. Any field in the application with an asterisk (*) next to it is required. Also note that the tabs across the top of the screen can be used for navigation, and that the Save and Submit buttons are at the top right of the screen.

16 ii) The bottom section of the main tab requests information about the charitable organization itself. Note that, if you answer yes to the question Are any members of the board of your organization government employees? then the If yes, please list name(s) section must be filled in. Navigate to the Program Information tab by clicking on the bottom of the screen, or use the tabs at the top. iii) The Program Info tab will ask for general information on the grant, as well as basic total budget information. Note that local currency must be chosen. Advance to the Attachments tab using the button at the bottom or the tabs at the top.

17 iv) On the Attachments tab, you will need to upload some required documents. To do so, click on the paperclip icon, and browse to the file on their computer. If you have additional attachments outside of what is requested, they can include those in the Additional Attachments section. Please note: The IRC 501c3 letter can be replaced by a government document confirming charitable/tax free status. v) Once all required information is entered, click Submit to finish the application. This will bring up a verification window informing you of your grant application number. Make note of this application number as it will serve as your reference number going forward.

18

19 C) Sponsorship Request Vertex supports events for a variety of different initiatives based on cross-functional business needs, that may offer various levels of funding opportunities (gold, silver, bronze). Examples of activities we support are: Examples of Programs We Support Table at a fundraising event Walks/rides & awards events Scientific or professional meetings Diversity internship programs i) Upon selecting Sponsorship, you will receive the following dialogue. Click OK to continue. The first step is to fill in information on your organization. If the information (address, phone number, etc) is the same as what you filled in during registration, you can use the Copy Profile button to transfer that data into these fields. Note that not all fields will carry over data, so they will still need to be filled in. Any field in the application with an asterisk (*) next to it is required.

20 Also note that the tabs across the top of the screen can be used for navigation, and that the Save and Submit buttons are at the top right of the screen. Navigate to the Funding Details tab by clicking on the bottom of the screen, or use the tabs at the top. We also ask for your organization s principal purposes. ii) The Funding Details tab will ask for a basic description of the event, as well as the range of support being asked, and the local currency. Once the necessary information has been filled in, click the Attachments button at the bottom or use the tabs at the top of the screen to navigate to the Attachments tab.

21 iii) The system requires supporting documentation for the event (such as an event brochure) and a request letter on organizational letterhead, which lists the price and benefits of the sponsorship. Please upload by clicking on the paperclip icon. Any other relevant documents can be uploaded in the Additional Attachments section by clicking on the Post New link. iv) Once all required information is entered, click Submit to finish the application. This will bring up a verification window of your grant application number. Please make a note of this number as it will be your reference ID going forward.

22

23 D) Corporate Membership Request i) Upon selecting Corporate Membership as the grant type, click the OK button to continue with the grant application. ii) At the next step, fill in information on the organization. Any field in the application with an asterisk (*) next to it is required. Also note that the tabs across the top of the screen can be used for navigation, and that the Save and Submit buttons are at the top right of the screen. Navigate to the Corporate Membership Info tab by clicking on the bottom of the screen, or use the tabs at the top.

24 iii) The following tab requests information regarding the purposes of the organization and the benefits of membership. This is also where you can select your local currency. Use the Attachments button on the bottom or the tabs at the top to navigate to the Attachments tab.

25 iv) We require that you upload a brochure and invoice. If you wish to submit any additional supporting documentation, click the Post New link next to the Additional Attachments field. v) Once all required information is entered, click Submit to finish the application. This will bring up a verification window informing you of your grant application number. Please make a note of this number as it will be your reference ID going forward.

26 E) Investigator Initiated Study Request Our Investigator Initiated Study grants support independent, investigator-initiated research designed to advance scientific knowledge of disease states, patient populations and medical treatment, in alignment with our clinical and nonclinical areas of interest. We work with leading researchers, doctors, public health experts and other collaborators who share our vision for transforming the lives of people with serious diseases, their families and society. Funding and/or drug support may be available for the following categories of research: Clinical studies involving KALYDECO (ivacaftor), ORKAMBI (lumacaftor/ivacaftor) and tezacaftor/ivacaftor Observational studies that support research into cystic fibrosis disease states (e.g., epidemiological and outcomes studies) Non-clinical studies using Vertex compounds for in vitro assays or in vivo models* *Compound only requests for nonclinical studies should be submitted directly to i) Upon selecting Investigator Initiated Study as the grant type, click OK to begin the application. ii) At the next step, enter some basic information on the study, such as study title and therapeutic area. Note that we are only accepting applications for Cystic Fibrosis at this time.

27 Next, fill in information on the Sponsor Investigator. If the information (address, phone number, etc) is the same as what the requestor filled in during registration, they can use the Copy Profile button to transfer that data into these fields. Note that not all fields will carry over data, so they will still need to be filled in. Any field in the application with an asterisk (*) next to it is required. Also note that the tabs across the top of the screen can be used for navigation, and that the Save and Submit buttons are at the top right of the screen. If you have any licenses, you may add them here as well. iii) The next required information is the Primary Study Site Information. Similar to the previous step, if this information is the same as what was entered into the Sponsor Investigator information fields, the data can be copied using the button.

28 iv) The bottom of the main tab requests information on additional site and personnel. To enter information, click the button to the right of the screen. This will bring up fields to be completed dependent on what type of information you are entering. For Additional Sites: For Key Study and Administrative Contacts (note that Role is a required field):

29 v) Navigate to the Study Design tab using the link at the bottom of the page, or the tabs at the top vi) The next step is to choose the type of study for the request Clinical or Non-Clinical. vii) Both study types will require information on the Study Timeline (to be entered in months). Note that the total duration will automatically calculate from the entered data.

30 Depending on the type of study, the information required in the next steps varies. viii) CLINICAL STUDY For Clinical Studies, the next step is to provide the Clinical Information. Following that, enter detailed study information such as primary and secondary objectives, scientific rationale, treatment plans, trial designs, inclusion criteria, etc. Please note that fields marked with an asterisk (*) are required.

31

32 ix) NON-CLINICAL STUDY For Non-Clinical Studies, provide the non-clinical information, beginning with the study model. Depending on the model, enter the animal model (In-Vivo) or the experimental system (In-Vitro or Ex- Vivo). Then, you will need to enter additional information in the sections below.

33 The information required from this point forward is the same for both study types. x) At the bottom of the Study Design tab, enter information on any planned publications. This can be done by clicking the button to the right, which will bring up fields to populate. xi) Navigate to the Support tab using the button at the bottom of the page or the tabs at the top of the page. xii) On the Study Support tab, select Product, Funding, or Product and Funding. xiii) For Funding Support, select the local currency type.

34 xiv) The requestor then needs to add both Direct and Indirect Costs. This can be done by clicking the button to the right. The total fields will calculate automatically based on the information entered. xv) The Direct Costs fields will start with a drop-down menu to choose which type of cost you are including. Please note the scroll bar to the right, which exposes the ability to upload an attachment related to the cost being entered. Enter each cost separately, and the system will automatically tabulate the total. Also note the space to enter the % Overhead being requested. The overhead will be automatically applied to the total Direct Costs. xvi) Other Cost Considerations can be entered as well. Please note that items entered into Other Cost Considerations are not included in the total overhead calculation.

35 xvii) The Total Budget and Amount Requested section will automatically calculate the total budget from the previous inputs. The requestor will need to enter the amount being requested from Vertex, as well as whether or not other support is being sought. xviii) To request Product, click the button on the right side of the screen in the Product Support Section. For Clinical Studies, there will be a drop-down with available compounds specific to the therapeutic area selected at the beginning of the application. For Non-Clinical Studies, the Requested Product field is free-text.

36 xix) Navigate to the Attachments tab using the button at the bottom of the page or the tabs at the top of the page. xx) The only required attachment at this stage of the application is the investigator s CV. However, additional relevant attachments can be uploaded by clicking Attachments section. in the Additional vi) Once all required information is entered, click Submit to finish the application. This will bring up a verification window with your grant application number. Note that this tracking number will be your reference ID going forward.

37 III. Reconciliations If you are awarded a grant request, you will need to reconcile the request after your activity has ended. We require that you reconcile the total project budget as well as upload documentation that the activity occurred (such as final programs, agendas, or outcomes). Note that requests must be reconciled within 90 days of the activity end date.

38 IV. Frequently Asked Questions 1) What is a Needs Assessment? A Needs Assessment is the process of identifying areas for improvement in a target audience, and determining the methods to achieve improvement. It takes place before the activity is designed. The purpose of a Needs Assessment is to make decisions regarding priorities for the program. The information can come from literature review, or surveys of local HCPs. Needs Assessments often answer the following questions: What evidence do we have that our audience needs this education? What evidence do we have that our solution will yield positive results? What is the reason that we are offering education in this format? 2) What is/why do I need a W8/501c3? A W9 or W8 is a tax document identifying an organization by their unique tax ID. This document is necessary in order to process payments. For most foreign grant requests, the W8 form is used while the W9 form is used in the United States. A 501c3 is a US Internal Revenue Service document that identifies an organization as a non-profit, charitable organization. For ex-us submissions, a comparable document indicating non-profit status will suffice. 3) What grant type should I select? Selecting the correct grant type is important. While one should be familiar with the descriptions from the main page, some general rules that might help determine grant type include: o Is the purpose of the event to provide medical education to healthcare practitioners (HCPs)? If so, it is likely medical education. o Are there different levels of rewards available for support at different monetary levels? If so, it is likely a sponsorship. o Is the main benefit to Vertex a showing of goodwill? In other words, will Vertex receive no tangible benefit from their support? If so, it is likely a charitable submission. 4) For Medical Education Grants, what do I put in Program Description? The Program Description field is a space for a brief description of what the proposed program is (e.g. 2-day disease-state specific conference). A more detailed description can be uploaded in the attachments section, but this field should be used to give a general idea of the shape of the event. 5) What is Evaluations and/or Outcomes Assessment?

39 This field is intended for a brief explanation of what outcomes the requestor hopes to achieve from the program, as well as how they intend to measure their success against those goals. For example, they may intend to demonstrate gains in knowledge through the use of pre- and postevent questions, measuring the change in correct answers. 6) I received the following error. What do I do? First, make sure that you write down the TEMP number. If you need assistance, this will be the way that Vertex staff can find your application, and it will also be available in the Tasks section of your account. Then see if there are items highlighted in red, like the below. Click on Go To Tab and fix the items in red. Then, submit again. If additional issues arise, they will be highlighted in red as well. 7) My computer got disconnected and I lost my application. Log into your account again and check your Task List. If your application has been saved, it will look like this: Save often! At the top-right and bottom-right corners of the application there are Save buttons. Some information will be required before saving for the first time (like Program Title). Saving often will eliminate the need to re-enter information if you get disconnected. 8) What is the status of my application?

40 You can review your current application status by clicking on All My Applications from the main page. Then, the status will appear under Other Information. You can also view the application from this menu. 9) When will I get paid/where is my check? Vertex pays within 45 days from receiving an invoice. Please wait to submit an invoice until our coordinator sends you a purchase order number; otherwise, the process will get delayed. If it has been longer than 45 days since sending your invoice, please ap_inquiry@vrtx.com to troubleshoot. 10) Why does my Start Date not work? Start dates must be 30 days in the future. If your start date is less than 30 days away, please vertex_grants@vrtx.com for instructions.