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External Research Program (ERP)21 June 2017
How To Apply
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Using the Practical Working Guide
The Practical Working Guide is divided into four sections:
Getting Started New ApplicationFull Submission Study Status Updates.
You will find hyperlinks throughout this document to aid with navigation.
Additional support:
Medtronic ERP Submission SupportWebsite: http://erp.medtronic.com/Email address: [email protected]
Visiontracker Technical Support Email address: [email protected] Numbers: Helpdesk UK & EU: +44 1403 322095Helpdesk USA: +1 860 266 4944Hotline USA: +1 860 266 4944 (9:00AM–4:00PM, EST).
Navigation
• The entries in the Table of Contents are hyperlinked;simply click on an entry to go to that section in this guide.
• To return to the Table of Contents from any point in this guide, click on the button.
• Hyperlinks are used throughout this document; to return to a slide after opening a hyperlink, hover over the bottom left-hand-side of the slide, click on the three dots or document icon (depending on version of PPT) and select Last Viewed.
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Table of Contents
• Mission Statement• Investigator-Initiated Studies • External Research Program Portal• Registration• Login• Landing Page
• Start a New Application• Submission Type
Concept Submission • Main Tab • Additional Personnel and Site Information • Study Design Tab • Attachments Tab• Submitting an Application
New Application
Full Submission Getting Started
• Provide Full Submission Information• Support Tab • Questionnaire Tab• Application Status • Additional Information Required
Study Status Updates
• Baseline Date Information• Study Status Update• IRB/Ethics/Animal Approvals • Study Deliverables• Final Deliverables • Amendments/Revisions • Invoices
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Getting Started
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Mission Statement
Medtronic is committed to the development of new technologies that improvepatient outcomes. The need for evidence that validates safety and efficacy is paramount in advancing the adoption of these new technologies. External Research Program (ERP) is one of the many tools Medtronic uses to support the development of this evidence.
The Medtronic ERP supports a global network of investigator-initiated research projects in the spirit of advancing medical and scientific knowledge. Focusing on the discovery, development and cultivation of cutting-edge therapies and diagnostics, the program fosters investigative research with the goal of improving the quality of patient care and clinical outcomes.
Areas of Research InterestMedical Devices
• Surgical Innovations – Advanced Energy and Stapling, Hernia, Access and Instrumentation, Wound Closure.
• Patient Monitoring and Recovery – Patient Monitoring, Ventilation and Airways, Capnography, Oximetry, BIS, Monitoring and Operating Room, Nursing Care, SharpSafety, Venous Solution.
• Early Technologies – Ablation Systems, Interventional Lung Solutions,Gastrointestinal Solutions.
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Investigator-Initiated Studies
Investigator-initiated studies are completely managed by a sponsor-investigator. This sponsor-investigator independently performs all the necessary work: creating the concept and design, developing protocol, following necessary regulatory and legal requirements, collecting data, conducting the statistical analysis, and publishing the study.
Investigators who plan to conduct an investigational device exemption (IDE) or investigational new drug (IND) study must submit the FDA application and conduct the study per the Code of Federal Regulations 812or 312, respectively.
Medtronic is not responsible for writing, submitting, or conducting the study.
Sponsor-investigators are required to follow their local regulatory requirements for investigational studies.
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External Research Program Portal
External Research Program Website: http://erp.medtronic.com/
• First time users will need to register.
• Click on the Process and Submission link on the right side.
• Scroll to review the ERP submission process, click ‘Register’ at the bottom of the page.
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Registration
• Complete the form and click ‘Register’.
• You will receive an email confirming registrationand User ID.
If you have any questions, contact [email protected]
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Login
External Research Program Website: http://erp.medtronic.com/
Forgot Password Use the link below the Password Field on the landing page, click ‘Forgot your Password’ to obtain or reset your password. The password will be sent to your registered email address.
Questions If you have questions or comments about the Medtronic External Research Program, please contact [email protected]
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User ID
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Landing Page
Click on the links on the left-hand-side of the Landing Page for company contacts, to update your profile, or obtain technical support. Additional links can be used to access the Medtronic Homepage, FAQ Document, and Practical Working Guide.
Task List The Task List will be empty when you first login. 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 underthis tab.
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New Application
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Start a New Application
To begin a new application, click the New Application button from theLanding Page.
Terms of UseThe New Application window will open asking the user to certify that the submission meets the listed terms and conditions associated with applyingand executing an educational grant.
Scroll through and read the information, check the box at the bottom acknowledging your review, then click ‘OK’.
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Submission Type
The New Application window will open, use the drop-down menuto select either Concept Submission or Full Submission.
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Full Submission The investigator will complete the full application for submission.
Concept Submission The investigator will complete and submit a conceptapplication for preliminary review. If the submitted concept is approved the investigator will be instructed to provide Full Submission information.
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Concept Submission
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.
Please note: The page will timeout and unsaved data will be lost if no movement occurs for 90 minutes, so please save often.
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Main Tab
The blue highlighted circle on the tab indicates which section of the application
is currently 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.
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Additional Personnel and Site Information
Scroll to the Additional Personnel and Site Information section on the main tab. Click ‘Add’ to open the ‘Additional Personal’ or ‘Additional Site Information’ window, complete the required information marked with an asterisk*, including institution and role, click ‘OK’.
Click ‘Add’ again to add additional personnel.
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Study Design Tab
The Study Design Tab contains sections on the design, study timeline,study synopsis, and preliminary publication plan. Complete all information marked with an asterisk*.
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Attachments Tab
There are four required documents that must be added via the Attachments Tab. To upload a document, click the paper clip icon to open the New Attachment window, choose the file to be updated, select the type, and provide abrief description. Click ‘OK’, and the document will then be listed. Repeat to add additional documents.
To attach additional documents 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.
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Submitting an Application
Completing the Application When the application is completed, the Submission Requirements bar will beat 100%. Click ‘Submit’, and then click ‘OK’ to confirm the submission.The applicant will receive an email confirming submission and a tracking number.
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Full Submission
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Provide Full Submission Information
Once your submitted concept has been approved, you will receive an emailwith a link to the Visiontracker system and instructions for providing the Full Submission information. The request will appear on your task list. Click ‘Provide Full Submission Information’ from the actions list. The application will open showing two new tabs, Support and Questionnaire, complete the requested information and then submit. *
* If Full Submission was selected as the submission type the application will contain all five tabs (Main, Study Design, Support, Questionnaire, and Attachments).
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Support Tab
The Support Tab contains sections on financial, product, and technical support. Complete all information marked with an asterisk*. Answer the four questions first, additional fields may open depending on the answers.
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Questionnaire Tab
Complete the fields marked with an asterisk on the Questionnaire Tab.
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Application Status
The application status updates will be added automatically within the system. Applicants can view the status of a submission using the All My Applications Tab.
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Additional Information Required
During the review process, you may receive an email asking for Additional Information, this will contain a link to the Visiontracker Web Portal. The request will appear on your Task List the next time you login. Click ‘Provide Additional Information’ to open your application.
The question(s) will appear at the top of the application. Provide the requested information and then submit the application.
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Study Status Updates
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Baseline Date Information
Once the application has been approved and the contract executed,the investigator will receive an email requesting them to log into the web portal and add the study baseline date information:
• The request will be posted on the web portal task list.
• Click ‘Provide Baseline Date Information’.
• Enter the required information in the Baseline Milestone/Enrollment section of the Study Status Update Tab, Save and then Submit.
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Study Status Update
Once the study has been approved the investigator can access and submit study status updates. In addition The investigator may receive an email requesting them to log into the web portal and provide study status updates:
• The request will be posted on the investigator’s Task List, click ‘View Application’.
• Scroll to Study Status Update section of the Study Status Update Tab, click ‘Add’ to open the Study Status Update window.
• Enter the requested information, click ‘OK’, click ‘Save’ then Submit.
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IRB/Ethics Committee Approvals
• Scroll to the IRB/Ethics Committee Approvals section of the Study Status Update Tab, click ‘Add’ to open the IRB/Ethics Committee Approvals window.
• Enter the requested information attach any required documents, click ‘OK’, click ‘Save’ then Submit.
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Study Deliverables
Study deliverables are determined and outlined in the contract. Study deliverables are tracked and managed on the Study Deliverable section of the Study Status Update Tab. Click ‘Add’ to open the Study Deliverable window, enter the requested information attach any required documents, click ‘OK’, repeat to add additional deliverables.Once entered, a list of deliverables with the associated status will appear.Updates should be made as the deliverables progress to competition.
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Final Deliverables
Upon study completion the investigator will receive an email with instructions to provide final study deliverables as outlined in the contact. This request will appear on the investigator’s task list.
Click ‘View’ or Add Final Deliverable Update, scroll to the Study Deliverable section of the Study Status Update Tab, click ‘Add’ to open the Study Deliverable window, enter the requested information attach any required documents,click ‘OK’, repeat to add additional deliverables. Save and then Submit.
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Amendment/Revisions to contracts budgets and protocols are communicated through the StudyStatus Update. Scroll to the Amendments/Revisions section of the Study Status Update Tab, click ‘Add’ to open the Amendments/Revisions Approvals window. Enter the requested information attach any required documents, click ‘OK’, click ‘Save’ then Submit.
Amendments/RevisionsReturn to Table of Contents
Study Status Updates
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Invoices
Invoices for milestone payments are submitted as Study Status Updates. Scroll to the Invoices section of the Study Status Update Tab, click ‘Add’ to open the Invoices window. Enter the requested information attach any required documents, click ‘OK’, click ‘Save’ then Submit.
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