Guidelines External Research Program


OVERVIEW / MISSION STATEMENT / PURPOSE

The Medtronic External Research Program (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.

Types of Studies Supported

Medtronic’s External Research Program (ERP) supports research involving the Company’s products. These studies are intended to add to the base of scientific knowledge expanding the practice of evidence-based medicine.

Studies that may be supported include:

  1. Label studies consistent with business strategy and applicable legal, regulatory and internal policy requirements.
  2. Studies of strategic importance to Medtronic. A list of such areas of interest is available upon request and is updated regularly.
  3. Prospective and retrospective studies.
  4. Studies having reasonable sample size and follow-up timelines.
  5. Studies having budgets that are of fair market value.
  6. Well-designed studies having an appropriate statistical plan.
  7. Studies may be clinical or non-clinical (benchtop, algorithm, cadaver or animal studies).

Medtronic may consider multi-center research studies if: there is a need and proper research support is in place. For multi-center ERP studies, the Investigator-Sponsor will be the Principal Investigator who be responsible for the conduct, coordination and compliance with regulations, laws and guidelines at all study sites. Typically, Medtronic will only contract with the lead site/Principal Investigator and it is the responsibility of the Sponsor-Investigator/Principal Investigator to contract with any additional center.

Studies that are not specifically focused on Medtronic products may be considered for support depending on the nature of the proposal and its importance to Medtronic.

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ROLES AND RESPONSIBILITIES

Investigator and Sponsor Responsibilities

  • The principal investigator of an investigator-initiated trial assumes the roles and responsibilities of the study sponsor, including compliance with regulatory requirements for applicable studies. As the study sponsor, the investigator has ownership of the study protocol and controls the data generated during the study.
  • Furthermore, the investigator is also responsible for securing all appropriate regulatory approvals as well as conducting the study and assuring the validity of the study data. The chart below highlights examples of some potential differences between an industry- sponsored and an investigator-sponsored study.
INDUSTRY SPONSORED INVESTIGATOR SPONSORED

PROTOCOL OWNERSHIP

The company owns the protocol and invites investigators to participate

The investigator owns the protocol and can submit to multiple funding sources for support

DATA

The company manages data with subject consent; the investigator typically has access to their data only

The investigator manages data with subject consent and gives company rights to use the data (if applicable) 

MONITORING

The company is responsible for conducting appropriate monitoring and may monitor the data to ensure validity

The investigator is responsible for study conduct and data validity

INTELLECTUAL PROPERTY

The company typically has rights to all intellectual property developed from the study data

The intellectual property rights may vary by study protocol

DELIVERABLES

Usually determined by the company

The investigator and company determine as part of any ERP agreement

PUBLICATION

The company and steering committee determine authorship

The investigator determines authorship


DEFINITIONS

SPONSOR PRINCIPAL INVESTIGATOR (PI) SPONSOR- INVESTIGATOR

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.

An individual who is responsible and accountable for conducting the study at a study site. The PI assumes full responsibility for the treatment and evaluation of the Clinical Subjects and for the integrity of the research data and results at the respective study site.

Note: The Principal Investigator may also be the Sponsor of the clinical study.

An individual who both initiates and conducts, alone or with others, a clinical study, and under whose immediate direction the study product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a Sponsor-Investigator include both those of a Sponsor and those of an Investigator.


WHO TO CONTACT

For any technical or business-related questions you may have regarding the External Research Program, contact erp@medtronic.com.

NOTE: If you need assistance with your ERP submission application due to a language barrier, please use the above email address and include your native language and country/location details. 


SUPPORTING AND FUNDING GUIDANCE

The types of support typically provided for external research are Funding and/or Provision of Products 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 an executed agreement 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, 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 included 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.

Examples of expenses for which Medtronic will not provide ERP 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

Provision of Product

If requested, Medtronic may provide support in the form of product including the loan equipment.

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.