- What is the review process/how long does it take?
- What are the review criteria?
- What type of information is needed to submit an application?
- Why is so much information necessary?
- What happens if there is a change in the protocol budget?
- Who is the sponsor of Medtronic investigator-initiated research studies?
- Does Medtronic support investigator-initiated studies using investigational devices?
- Will Medtronic support a multi-center study?
- Who will have access to my study proposal (confidentiality)?
- For device studies, do patients need a Medtronic device/product for me to receive support? Can competitors devices be included?
- What is required for preparation of the contract?
- What is required in the study budget?
- What role does Medtronic's regulatory department play in my study review and approval?
- Does Medtronic require IRB/MEC/IACUC protocol approval?
- How should the patient informed consent be developed?
- When does Medtronic consider a study to be activated and provide initial payment?
- Should I register my clinical study online?
- What are Medtornic's expectations for reporting on study progress?
- Will a Medtronic representative monitor the data or CRFs for my study?
- Who is responsible for reporting study-related adverse events?
- What should I expect if my study is delayed or has trouble with enrollment?
- Who would be assigned the rights to a patent that is generated because of a Medtronic supported investigator-initiated study?
- Can I publish my study results and do I need to inform Medtronic?
- Is study-related compensation reportable under the Sunshine Act (US only)?
- Does Medtronic provide research areas of interest?
- Can end user access the ERP web application and ERP Website using IE or will they need Chrome, etc? Are they iPad or iOS phone friendly?
1. What is the review process/how long does it take?
Research ideas should be submitted online at erp.medtronic.com. An idea concept submission is not required, but can be utilized by the Investigator if he/she chooses to submit a study concept prior to filling out the entire study application. We encourage initial submissions to be brief, so Medtronic can assess interest prior to the investigator investing substantial time into a study protocol. Review of the submission is performed by an internal group of Medtronic personnel within the device and disease area of interest and a response is provided to the investigator within 60 days. If a study submission is missing documentation or requires additional information, this process may take longer. If an official decision is delayed for any reason, the delay will be communicated within the same timeframe. If the project is conditionally approved at this stage, a complete version-controlled protocol, and detailed budget which will be reviewed by the Medtronic ERP Board. This review will include regulatory and a fair market value assessment.
2. What are the review criteria?
Proposals are reviewed according to the following criteria:
- Adequate study design, including scientific soundness, safety, and human subjects’ protection technical feasibility of the use of the product
- Strategic fit
- Research concept is novel
- Investigator’s qualification
- Regulatory status
- Budget in alignment with Fair Market Value (FMV)
3. What type of information is needed to submit an application?
The following information is needed for final review by the ERP Review Board:
- Contact information
- Details about the proposed study (the protocol is required when completing a Full Submission application)
- Detailed request for support
- Information about your research experience and available resources
- Investigator(s) CV(s)
5. What happens if there is a change in the protocol or budget?
Updated protocol, budget, IRB or Ethics Committee approval must be submitted to Medtronic in a timely manner to be kept on file. Depending on the changes, they may require the approval of the ERP Review Board and/or contract amendments.
6. Who is the Sponsor of Medtronic investigator-initiated research studies?
Sponsor |
An individual, company, institution, or organization that takes responsibility for the initiation, management, and / or financing of a clinical trial. Note: The regulatory / legal definitions of “Sponsor” and associated indicators of sponsorship may vary by geography. |
8. Will Medtronic support a multi-center study?
Yes, Medtronic may support multi-center studies. Please be advised, for multi-center ERP studies the Investigator-Sponsor will be the Principal Investigator who will be responsible for the conduct, coordination and compliance with regulations, laws and guidelines at all study sites. Medtronic will only contract with the Investigator-Sponsor and it is the responsibility of the Investigator-Sponsor/Principal Investigator to contract with any additional centers.
If, after approval and/or activation as a single-center study, both you and Medtronic agree that additional centers are needed, approval from Medtronic is required prior to expanding your study to other centers.
9. Who will have access to my study proposal (confidentiality)?
Each project proposal submitted to Medtronic’s External Research Program is reviewed by our cross-functional review Board for originality, scientific merit, strategic alignment, and other criteria. The submission details will be reviewed by Medtronic personnel that are subject matter experts as well as personnel responsible for the management and oversight of the External Research Program (ERP).
10. For device studies, do patients need a Medtronic device/product for me to receive support? Can competitor's devices be included?
Medtronic considers proposals involving Medtronic devices, products, or therapies. Studies that are not specifically focused on Medtronic products are also considered for support.
Medtronic may permit non-Medtronic devices in cases of registries, retrospective reviews, or head-to-head comparison trials. Other exceptions may be studies aimed at learning more on the pathology of disease.
11. What is required for preparation of the contract? The following is required for preparation of the contract:
Once the MDT ERP board approves the ERP submission, the contracting preparation can begin. In order to prepare the contract, the finalized protocol with version and date within the document as well as the finalized study budget are required.
12. What is required in the study budget?
The types of support typically provided for external research are Funding and/or Provision of Product depending upon the type of research; in some cases limited Technical Support can be provided. Each is described in further detail below.
Please note: No support will be provided until a mutually agreed upon contract is in place.
Funding
If requesting funding support for all or part of the study costs, prior to receiving final approval for your research project, Medtronic must review and approve a study budget. Budgets must be itemized by study task and procedure, be inclusive of overhead/fringe, if applicable, and must reflect reasonable study related costs in alignment with fair market value. Your budget will be compared with other investigator-initiated research studies, Medtronic-sponsored research studies, CMS, or other resources to determine its equivalence with fair market value.
Typical items that may be considered in the Budget are:
- Subject-related costs
- Study-related personnel costs (i.e., research personnel, statistical support, medical writer; include number of expected hours on study and hourly rate)
- Diagnostic fees and services
- Data management expenses
- IRB review fees
- Equipment/supplies
- Travel in direct support of study execution; must be clearly itemized in budget up front as part of original submission and show relationship to research
Medtronic may provide funding for study related procedures that are conducted for research purposes only, and which are not considered standard of care or billable. Medtronic does not provide funding for “standard of care” and/or “billable” procedures, and it is your responsibility to pursue such reimbursement from third party payers or other appropriate resources.
Example of expenses that Medtronic will not provide funding include:
- General educational and training activities
- Support for ongoing clinical programs that are part of an organization’s routine operations
- Start-up funds to establish new clinical or research programs or to expand existing programs
- Purchases of capital equipment unrelated to the study or that would generate revenue
- Construction funds to build new facilities
- Hiring of staff that are not dedicated to the study
- Travel to conferences to present study results
- Manuscript writing
- Publication preparation and submission
- Idea or protocol development
- Research activities that were completed prior to ERP Submission
Provision of Product
If requested, Medtronic may provide support in the form of product including the loan of capital equipment or disposables.
Technical Support
Medtronic may provide limited technical support activities if, and to the extent, Medtronic has unique capabilities and expertise required for the study conduct.
14. Does Medtronic require IRB/MEC/IACUC protocol approval?
Yes. Medtronic must receive a copy of the Investigational Review Board (IRB), Medical Ethics Committee (MEC), or Institutional Animal Care and Use Committee (IACUC) protocol approval letter for the study before any payments or product can be provided. If a waiver is granted by the IRB/MEC/IACUC instead of study approval, Medtronic must receive a copy of the waiver documentation. There may be exceptions where, due to the nature of the study, neither approval nor waiver is required by your IRB/MEC/IACUC and in these cases documentation of that will be acceptable.
15. How should the Patient Informed Consent be developed?
It is important to note that Medtronic is not the sponsor of your investigator-initiated trial and should not be identified as such in the Patient Informed Consent, the protocol, or any other documents. As the sponsor-investigator of the study, you are responsible to obtain IRB/MEC approval for your study, if required. It is your responsibility as the sponsor to ensure that the Patient Informed Consent meets all legal, clinical, and IRB/ MEC requirements. As you develop the Patient Informed Consent, please pay particular attention to the following:
- Medtronic is not listed as the study sponsor
- Medtronic is not responsible for patient injury or any coverage of patient injury-related costs
- Medtronic is not responsible for communicating safety risks to patients
- The Patient Informed Consent accurately describes the data that Medtronic will receive from the study, and how Medtronic may use the data.
16. When does Medtronic consider a study to be activated and provide initial payment?
The following items are required by Medtronic before initiating your first study payment:
a. Study agreement signed and dated by all parties, including any Exhibits needing signatures/dates
b. Medical Ethics approval of the study: Copy of the IRB/MEC (or IACUC if animal study) approval letter or written notification from the IRB/MEC/IACUC that the protocol does not need to be reviewed
c. Copy of the final protocol with version and date included within the document
Given that you are the study sponsor, enrollment may begin at any time, but funding is not guaranteed, and Medtronic will not make any payments, until all the noted paperwork required by your agreement is on file with Medtronic.
Please note: all payments are based on milestones outlined in your study agreement. Start-up costs may or may not be included as a milestone.
17. Should I register my clinical study online?
Yes. Because of the International Committee of Medical Journal Editors (ICMJE) initiative and FDAAA requirements, Medtronic suggests that you register your clinical trial unless we agree that registration of the clinical trial is inappropriate. One such online clinical trial registration system is: www.clinicaltrials.gov.
18. What are Medtronic’s expectations for reporting on study progress?
Medtronic expects regular progress reports as outlined in the ERP Agreement to document study progress and determine whether payment milestones have been met. Study payments will be made upon documented milestone achievement. If reports are not received according to the schedule outlined in the ERP agreement, Medtronic may decide to discontinue support.
19. Will a Medtronic representative monitor the data or CRFs for my study?
Medtronic does not monitor investigator-initiated studies; however, to ensure quality data collection, Medtronic expects investigators to follow good clinical practices (GCP):
- http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm
- http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
Medtronic may request copies of research subject datasets or a copy of the summarized de-identified data as outlined in a mutually agreed upon ERP agreement.
20. Who is responsible for reporting study-related adverse events?
The Investigator is responsible for reporting study-related adverse events through their normal channel as required by applicable federal, state and local laws.
For more information on reporting adverse events, please refer to the websites below:
21. What should I expect if my study is delayed or has trouble with enrollment?
Study execution is expected to be completed in a timely manner. If the study is delayed, please contact your ERP representative so MDT is aware of this delay. Your ERP representative may discuss suggestions for increasing enrollment strategies.
22. Who would be assigned the rights to a patent that is generated because of a Medtronic supported investigator-initiated study?
Your research contract with Medtronic will include specific information describing Medtronic’s requirements for the assignment of intellectual property associated with the study. Please refer to the “Intellectual Property” section of your research contract for specific guidance.
23. Can I publish my study results and do I need to inform Medtronic?
Yes. Publication of study results is recommended for clinical research conducted in order to ensure full transparency of the study results. Please notify your Medtronic External Research Program contact if you plan to submit an abstract or manuscript and abide by any requirements described in your contract. Medtronic will ask you for a copy of the abstract or manuscript to review prior to submission. We require prior review to ensure technical accuracy and appropriate documentation of any Medtronic intellectual property prior to public disclosure.
24. Is study-related compensation reportable under the Sunshine Act (US only)?
Yes. The US Open Payments (Sunshine Act) program requires device manufacturers to report support provided for external research, including payments, products, supplies, and services. The US government’s research report requirements include identifying a principal investigator as well as the payee or site. Support might also be reported when required by state laws, such as in Vermont.
25. Does Medtronic provide research areas of interest?
Yes. Please contact erp@medtronic.com for further information.
26. Can end user access the ERP web application and ERP Website using IE or will they need Chrome, etc? Are they iPad or iOS phone friendly?
The ERP web application and ERP website both render in mainstream browsers (IE, Chrome, Safari, Firefox, Opera) without issue. iPad and iOS (iPhone) users can render the website and the web application, but the web application doesn’t have a mobile friendly version of the site, so it will display a full page, which is difficult to navigate on a small screen or with a touch screen.