Frequently Asked Questions

A concept submission is an abbreviated External Research Program (ERP) proposal which requires site and investigator contact information, a study summary and intended support requested.  A concept submission is not required but is highly encouraged and allows for a Medtronic assessment of study interest/feasibility prior to the Sponsor-Investigator investing substantial time into a study protocol.  If the proposal is conditionally approved at the concept stage, a full submission research proposal is required. Please note the final support decision is made on the final protocol and budget, not the concept submission alone.

A full submission proposal may be completed in place of a concept submission if a completed protocol and full study details are available at time of research submission. A version-controlled protocol, investigator curriculum vitae (CV), detailed study budget, if requesting support, and full submission proposal are required and will be reviewed by the Medtronic ERP Board for final decision.

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 proposal)
• Detailed request for support
• Information about your research experience and available resources
• Principal investigator curriculum vitae (CV)

Yes. Please contact us for further information.

Yes, Medtronic will support Investigator-sponsored studies using investigational devices if the internal review board approves support of the submission.

Yes, Medtronic may support multi-center studies. Please be advised, for multi-center ERP studies, the Sponsor is responsible for the overall conduct, coordination and compliance with regulations, laws, and guidelines at all study sites. Medtronic will only contract with the Sponsor, and it is the responsibility of the Sponsor to contract with the additional center(s).

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 studies. Other exceptions may be studies aimed at learning more on the pathology of disease.

While iPad and iOS (iPhone) users can render the website and the web application, the web application does not 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.

Review of the submission is performed by a Medtronic ERP Board within the device and disease area of interest, and a response is provided to the Sponsor-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. 

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
• Investigator qualification
• Regulatory status
• Funding availability and budget in alignment with fair market value (FMV)

Each project proposal submitted to the Medtronic External Research Program is reviewed by our cross-functional review board. 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.

Medtronic's regulatory department may evaluate whether your study is using Medtronic devices according to approved labeling.

The sponsor of a Investigator-Sponsored research study is a company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical ERP.

Note: The regulatory or legal definitions of sponsor and associated indicators of sponsorship may vary by geography.

For additional detail, please download the budget template.

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
• Institutional Review Board (IRB) or Ethics committee 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

Once the Medtronic ERP board approves the ERP submission, the contracting preparation can begin. In order to prepare the research agreement, the finalized protocol with version and date within the document as well as the finalized study budget are required.

Medtronic does not monitor Investigator-Sponsored research; however, to ensure quality data collection, Medtronic expects Investigator-Sponsor to follow good clinical practices (GCP):

• https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
• https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials
• https://www.ich.org/page/efficacy-guidelines
• https://www.ich.org/news/draft-principles-ich-e6-good-clinical-practice-gcp-now-available

Medtronic may request copies of research subject datasets, or a copy of the summarized de-identified data as outlined in a mutually agreed upon research agreement.

Your research agreement with Medtronic will include specific information describing assignment of intellectual property related to the study. Please refer to the "Intellectual Property" section of your research agreement.

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.

It is important to note that Medtronic is not the sponsor of your Investigator-Sponsored research 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 for obtaining 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.
  

Yes. Because of the International Committee of Medical Journal Editors (ICMJE) initiative and to ensure compliance with applicable regulatory requirements, Medtronic suggests that you register your clinical study. One such online clinical study registration system is: www.clinicaltrials.gov.

The following items are required by Medtronic before initiating your first study payment: 

• Research agreement signed and dated by all parties, including any exhibits needing signatures/dates. 

• 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. 
  
  
• 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 research agreement is on file with Medtronic. 

Please note: All payments are based on milestones outlined in your research agreement.

Medtronic expects regular progress reports as outlined in the research 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 research agreement, Medtronic may decide to discontinue support.

The Sponsor-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:

• https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
  
• https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems 
  
• http://www.imdrf.org/index.asp
  

A change in protocol or budget must be submitted to Medtronic in a timely manner to be kept on file. Changes may require approval from the ERP review board and/or contract amendments.

Study execution is expected to be completed in a timely manner. If the study is delayed, please contact your Medtronic ERP representative so Medtronic is aware of this delay.

Yes. Publication of study results is recommended for clinical research conducted to ensure full transparency of the study results. Please notify your Medtronic ERP representative if you plan to submit an abstract or manuscript and abide by any requirements described in your research agreement. Medtronic requires review of abstracts and manuscripts prior to submission to ensure technical accuracy and appropriate documentation of any Medtronic intellectual property prior to public disclosure.

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 applicable state or regional laws.