29 October 2019 - Envision Pharma Group · 29 October 2019 . Objectives The purpose of this guide...
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Confidential - Take all necessary precautions to protect its contents 29 October 2019
Transcript of 29 October 2019 - Envision Pharma Group · 29 October 2019 . Objectives The purpose of this guide...
Confidential - Take all necessary precautions to protect its contents
29 October 2019
Objectives
The purpose of this guide is to:
• Introduce users to the Otsuka Sakura IME & CC module.
- Please refer to Navigating iEnvision User Guide for system features and navigation.
• Demonstrate how to create and submit Grant applications.
Additional Support
• Otsuka Support
- Support Line US: +1 800 438 6120
• Envision Technology Solutions (ETS) Help Desk:
- Email: [email protected]
- Phone: US: +1 860 266 4944
UK & EU: +44 1403 322 095
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• Logging In
• User Registration
• Forgot Login/Password
• Dashboard
• Workbench
• Creating a New Application
• Acknowledgment
• Attestation
• Program Details
• Organizations
• Activities
• Budget
• Attachments
• Submission
• Request for Additional Info
• Letter of Agreement (LOA) Process
• Request Change of Scope
• Activity Updates
• Program Closure
• Program Outcomes
• Budget Reconciliation
• Transfer of Value
• Technical Support
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Hyperlinks throughout this guide provide quick and easy navigation to specific topics.
Click the home icon to navigate back to the Table of Contents.
• The tabs at the top of the main Login page contain information on How to Apply for first time users, Our Process detailing Otsuka’s end-to-end investigator-sponsored study platform process, and an FAQ (Frequently Asked Questions).
• Should you experience technical difficulties, click Contact Us for technical support.
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If you are a new user, click here to register
for a new account
• When registering as a new user, be sure to fill out all available fields to ensure that the “Copy from Profile” functions work correctly.
• Use the search bar indicated above to find your organization to associate it with your account; you will also be able to add a new organization if required.
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• To search for your organization, enter your tax code into the search bar, and click the magnifying glass. If your organization does not appear, click Add New Organization.
• When adding a new organization, enter as much information as possible in the fields provided to aid with your application in later steps.
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From System Login…
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Click Forgot Login ID? and enter your email address to receive an email with your login details; then click Submit.
Click the Forgot Password? and fill out the pertinent information; then click Submit.
Upon logging in, you will open the user Dashboard. The Dashboard includes:
1. Navigation icon: Clicking here will allow you to navigate between your Dashboard and Workbench.2. Global icons: From left to right, you will see the icons for FAQ, Notifications, your Profile, and details
about iEnvision.3. Welcome: This screen identifies the user logged in, as well as any items that require your attention. You will
also be able to view brief summaries of unmet needs and practice gaps.4. Announcements: System and program announcements are displayed here.5. Recent: Any documents that were recently accessed by the user.6. Start New…: Create a new grant application.
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• On the left-hand-side of the Workbench, you will see the most recent applications that have been submitted and require your review.
• When you select an application, an overview of the application will be shown on the right-hand-side of the screen. To view details or continue an in-progress application, click thegear icon and select Open Details.
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• To start a new application, click Start New….
• Next, select the type of application that you will be submitting. Click Continue at the bottom right of your screen.
- Please note that while this guide shows details on how to complete an Accredited Education Program application; this guide can also be used to assist completion of any of the three application types, including Non-Accredited Education Program and Charitable Contributions.
• Please note that when creating a new application, a temporary request ID is assigned until the application is successfully submitted. The Status of the application will also read “Incomplete” until submitted.
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• You will be required to check the box at the bottom of the acknowledgment section that states you have read, understand, and agree to the Acknowledgment. Once you have clicked the box, you can continue by clicking Attestation once it appears on the bottom right-hand-side of your screen.
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• The next section of the application is the Attestation. Per the guidance on this page, please read and answer each question to attest to your understanding of and willingness to comply with policy statements regarding the support and administration of the program you are applying for financial support. Once you have answered the questions, scroll to the very bottom of the section and click Program Details to progress your application.
On the Program Details section, you are required to fill out details of the program for which you are seeking funding.
Required fields for this section include:
• Program Title• Therapeutic Area• Start Date and End Date of the Program• Accrediting Organizations (if applicable)• Outcome Measures/Plans• Audience Description• Geographic Reach• Associated Congress (if applicable)
To add an Associated Congress, click the magnifying glass next to the field.
To search for a congress, enter a keyword into the search bar, enter the dates of the event, and click Search. A list of congresses matching the criteria will appear at the bottom of the screen. Should you be unable to find the congress you are looking for, click the word here at the bottom of the window to add the congress manually.
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• Scrolling down on the Program Details page, find sections where you can detail:
- Program Description
- Learning Objectives
- Needs Assessment
- Recruitment Plan
- Prior Experience
• For each of the text boxes, you are able to either format text you entered, or insert a Word document.
• You are required to upload documents for:
- Grant Request on Letterhead
- Program Agenda/Overview
- Needs Assessment with References
• Once all of the fields for Program Details have been filled, and all required attachments uploaded to the request application, click Organizations at the bottom right-hand-side of the screen to progress the application.
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• Next, you need to enter details for the applicant and payee Organizations. You can enter details by clicking Copy from next to the search bar, and clicking Profileor Payee.
• You can also search for an organization using the search bar.
• Mandatory information includes field entries indicated with an asterisk, and attaching your W8/W9.
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• Once all information for applicant has been entered, scroll down and click Payee to open and complete this section. You can copy information from either your profile or the Applicant section using the Copy from function. Repeat for your Accrediting Provider.
• After entering the required information for Applicant, Payee, and Accrediting Provider, scroll down and click Activities on the lower right-hand-side of your screen to progress the application.
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• Click + Add Activity to select the type of additional information you want to add, and complete the fields, for example, additional information about the Venue, and Occurrences.
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Options to click include:
1. +Add Venue to enter information about the activity’s venue.
2. +Add Occurrence to duplicate the activity already entered should another occurrence of the activity take place at a later date.
3. +Add Activity to add another activity.
Example:
• Click + Add Venue and search using the search bar at the top of the window or enter the venue’s information manually.
• Once you have enter all of the activities associated with your program, scroll down to the bottom of the page and click Budget to progress the application.
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• On the Budget section, the financial details on the right-hand-side will update automatically as line items are added to the table on the left.
• To fill the table with line items, click + Add Line, and add each item that falls within the budget of your program.
• Alternatively, you can upload a budget template to populate the table. Click Download Budget Template at the top left of the screen. You will then be prompted to save an Excel budget template. Once the template has been filled, click Upload and Extract. All values entered will be extracted from the template, and moved to the table.
• Once all budget line items have been added, ensure that the USD amount requested for each line item has been added. Click Save once all updates have been completed.
• Click Attachments to progress the application to the next step.
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• On the Attachments screen, you can review or add attachments within your application. After reviewing your attachments, click Summary at the bottom right-hand-side of your screen to review a consolidated view of your application.
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• Once you have reviewed your application to your satisfaction, click the Actions menu at the top right hand corner and select Submit.
• Confirm that you would like to submit your application and your application will then be forwarded for internal Otsuka review.
• Now that the application has been submitted, a permanent Grant ID will be assigned to your application.
• You can check the status of your application by referring to your Workbench or Dashboard.
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• If additional information is deemed necessary to complete the review of your grant request, you will receive an email specifying the incomplete/missing information. A window containing the information will also be available after logging back into the system.
• Once you have updated your attachments or application content with the information requested, click the Actions menu and select Submit Additional Info.
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• Once your application has been reviewedand an approval decision has been reached, the LOA process will be initiated. In addition to your approval email, you will receive an email directly from DocuSign with a link to electronically sign the LOA.
• Please note that the LOA will be routed to the primary contact of the Payee Organization, as well as the contacts for any joint sponsors listed for the program.
• Once the LOA Process is completed, your application will enter the Program Active state.
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• If, after your grant has been approved, you have a change of scope that would affect the LOA, click the Actions menu and select Request Change of Scope. This will open up your application again, and make all items editable.
• Once you have updated your application content with information that required a scope change, click the Actions menu and select Submit Change of Scope.
• Please note that your application will now have to undergo the review process again and may be subject to denial or approval at a lesser amount. A new LOA may require a signature as well.
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• For programs consisting of multiple activities, you will be expected to provide updates as each activity has concluded.
• On the Activities page, expand each activity entry to enter the final details:
- Actual Start and End Date
- Final Participant Details:
• Audience; Therapeutic Specialty; Total Number; Total Credits (only applicable for live, accredited activities)
• For all participant details, please add a separate row for each unique Audience and Therapeutic Specialty combination (eg, Primary Care + Nephrology).
• Once all information has been completed, select “Submit Activity Update” from the Actions menu.
• Upon reaching the end of a program’s duration, a set of activities will have to be completed in order to successfully close out the program. To begin the process, click the Actions menu and select Open for Program Closure.
• This action will activate three new Closure sections of the application:
- Activities (120 days from Program End)
- Budget (90 days from Program End)
- Transfer of Value (if applicable) (90 days from Program End)
IMPORTANT: Please note that each closure activity will have its own Due Date (listed above) and may be submitted independently via the associated actions in the Actions menu.
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• Program Outcomes consists of the following components:
1. Activity Participant Reconciliation: If not completed during the active program phase, this Actual Audience data is now required.
2. Outcomes: Corresponding questions display based on Actual Outcomes Level selected.
3. Documentation: Actual Outcomes Comments, etc., attachment files are required to be uploaded to accompany the outcomes submission.
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• Select the actual level of outcomes reached for the program based on the Moore’s Levels of Outcomes.
• Once selected, select Save from the Actions menu to display the questions associated with the actual level reached.
• Please note, for Level 1: Program Participation:
The program participation is designed to aggregate the participation entries within each activity. All participant information should only be entered for each corresponding activity and not directly within the program participation table.
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• In the Budget section, start by expanding each row of the existing budget.
- Previously entered information is displayed for quick reference.
- Enter the Actual Cost and Actual Funds Used totals for each line.
• Add or remove rows from the budget table, if needed.
• Each update will be reflected in the summary section to the right of the main table.
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• Expense Totals
Sums each Expense Type within the table.
• Total Program Revenue
Enter Actual numbers for registration fees and other non-grant support received to help cover the cost of the program.
• Total Program Budget
The Actual Program Revenue will automatically be subtracted from the Actual Program Cost to equal the Actual Program Budget.
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• Actual Funds Used
- The initial Requested Amount, along with the official Approved Amount, will be displayed for reference.
- The Actual Funds Used will sum the entries within all budget line items.
• Refund Owed
- If the Actual Funds Used are less than the Approved Amount, a preliminary Refund Owed value will appear.
- Please note that this amount is not official. Any actual refund request will be sent in a formal request after the budget reconciliation has gone through internal review.
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• Prior to the approval of your program, it is a requirement that an internal determination will be made as to whether or not transfer of value reporting will be required at program completion.
- If determined to be required, this section will automatically appear during the closure activities.
• To complete the transfer of value submission, select +Add Item and then select either Physician or Teaching Hospital.
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• Covered Recipient Information
- Enter the applicable data for the covered recipient type. Note that there are slight data differences between Physician and Teaching Hospital.
- Ensure that all information is as complete and accurate as possible prior to submission.
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• Payment Information
- Complete all relevant payment data fields.
- Ensure that all information is as complete and accurate as possible prior to submission.
Otsuka Support
- Support Line US: +1 800 438 6120
Envision Technology Solutions (ETS) Help Desk
- Email: [email protected]
- Phone: US +1 860 266 4944
UK & EU +44 1403 322 095
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