Table of Contents Who should an Investigator contact to submit an ERP proposal? What type of information is needed for Medtronic to review? Is a protocol required? Why is so much information necessary? How long does it take for a submission to be reviewed? Can Investigators submit study proposals for animal research? Do Investigators have to submit a study proposal if requesting devices only? Who reviews the ERP submissions? What type of study is Medtronic most likely to fund? How much influence/support with the study design and conduct should Investigator expect from Medtronic? What happens after a study proposal is approved? What happens if there is a change in the protocol or budget? What is expected of the Investigator upon final approval and contract execution? What is expected upon completion of the study? How do I register on Visiontracker? How do I update my profile? How do I view or open a saved application? How do I print my application? How do I copy an application? How long does my Visiontracker session last? How do I update my username or password? How do I attach a document? 3 3 3 4 4 4 4 5 5 5 6 6 7 7 7 7 11 11 11 14 14 14 Note: You can click on the question to hyperlink to the answer. 2
Frequently Asked questions 1. Who should an Investigator contact to submit an External Research Program (ERP) proposal? Answer: Please go to our website Website: http://erp.medtronic.com/ or contact Email address: erp@medtronic.com 2. What type of information is needed for Medtronic to review? Answer: The following information is needed for review by the ERP Review Committee: Contact information Details about the proposed study Detailed request for support Information about your research experience and available resources Investigator(s) CV(s) Copy of Medical License 3. Is a protocol required? Answer: No, but if a draft protocol is available, it would be helpful to attach it to your submission. 3
Frequently Asked questions 4. Why is so much information necessary? Answer: Several factors are assessed, among them: study design, rationale, strategic interest, scientific merit, site capabilities, budget alignment, and risk. Proper documentation is necessary due to ant kickback statutes and the Federal False Claims Act. 5. How long does it take for a submission to be reviewed? Answer: The ERP review committees meet regularly to review submitted proposals. Submission deadlines and meeting dates are posted to the ERP website. 6. Can Investigators submit study proposals for animal research? Answer: Yes, the ERP process covers both animal and human research proposals. 7. Do Investigators have to submit a study proposal if requesting devices only? Answer: Yes, approval is needed for device only requests. There are four types of support that can be requested for ERP: Funding support Equipment and/or device support Medtronic technical support Existing patient / product data 4
Frequently Asked questions 8. Who reviews the ERP submissions? Answer: A cross-functional team from Medtronic reviews all completed ERP submissions. Team members represent Clinical Affairs, Medical Affairs, and Regulatory Affairs. Clinical Affairs and Medical Affairs vote to determine the outcome of each proposal. 9. What type of study is Medtronic most likely to fund? Answer: Studies utilizing Medtronic new or existing technology. Studies with endpoints showing the economic benefit of Medtronic technology or surgical technique that utilize Medtronic technology. Studies with endpoints showing the clinical benefit of Medtronic technology. 10. How much influence/support with the study design and conduct should Investigator expect from Medtronic? Answer: There should be minimal influence from Medtronic. Under ISO 14155 and 21 CFR the sponsor of a clinical study is responsible for the conduct of the study and its development. Medtronic can make recommendations to help improve and better align the study with strategic goals. Medtronic will process all documentation as expeditiously as possible through its internal system. It is expected that the investigator will do the same at their institution. 5
Frequently Asked questions 11. What happens after a study proposal is approved? Answer: A conference call will be scheduled to discuss next steps and investigator responsibilities. Contract language, protocol, and budget should be finalized. Final approval is given by Medtronic s Grants and Compliance Committee (GCC). Prior to starting the study, GCC approval, a final protocol, budget and fully executed contract are needed. It is the responsibility of the investigator to ensure that the protocol is in accordance with all regulatory and GCP requirements. The following are to be submitted and approved by Medtronic Clinical Affairs prior to receiving support: Final protocol Final budget IRB / EC approval letter or waver Final approved contract Updated investigator CV The investigator is responsible to diligently work with their institution to complete the above items within a reasonable time frame. A Clinical Research Associate will be assigned to the program. They will work with the investigator to assure the above items are completed and they will follow up with the investigator to obtain quarterly reports regarding the status of the study. 12. What happens if there is a change in the protocol or budget? Answer: Depending on the changes, they may require the approval of the ERP review committees. This will be done on an expedited basis. 6
Frequently Asked questions 13. What is expected of the Investigator upon final approval and contract execution? Answer: For all ERP s, the investigator is considered to be the Sponsor of the study according to ISO 14155 and 21 CFR. To this point Investigator is responsible for the overall conduct of the study in accordance with GCP. The investigator is responsible for the development of the study as defined in the final protocol, mutually agreed upon contract and budget. It is expected that the investigator will work diligently to complete the study in a timely manner. Please see Medtronic External Research Program (http://erp.medtronic.com/) for more information. 14. What is expected upon completion of the study? Answer: Medtronic expects publication of the results from the study. This can be in the form of a Journal Publication, abstract or scientific meeting presentation. Generally the timeframe for obtaining this deliverable is 6 to 12 months after the study is completed. 15. How Do I Register on Visiontracker? Answer: Please see to the Getting Started Section of this guide. 16. How Do I Update My Profile? Answer: Please see the Registration page of this guide. 7
Getting Started 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. 8
Getting Started Registration Complete the form and click Register. You will receive an email confirming registration and User ID. If you have any questions, contact erp@medtronic.com 9
Getting Started 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 erp@medtronic.com User ID 10
Frequently Asked questions 17. How do I view or open a saved application? Answer: Please see the Landing Page in this guide. 18. How do I print my application? Answer: During any point of the application process you have the ability to generate a PDF print-out of your entire application. The Print icon is located in the application toolbar, next to the Save and Submit buttons. It is important that you use this Print button and not the printing function of your Web browser. 19. How do I copy an application? Answer: The Copy application feature is available on the Task List or All My Applications list. 1. Locate your application from either tab section 2. Below the banner that reads What would you like to do? select copy Application 3. You must agree to the submission agreement before, then click ok 4. Begin your new copied application 11
Getting Started 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 under this tab. 12
Frequently Asked questions 20. How long does my Visiontracker session last? Answer: Your Web session will time out after 90 minutes and you will be prompted to reenter your Username and Password information. Like many other Web applications, this is in place for security purposes. 21. How do I update my username or password? Answer: Please see the Registration page of this guide. 22. How do I attach a document? Answer: Please see the Attachments Tab page of this guide. 13
New Application 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 a brief 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. 14