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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.
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:
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.
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 |
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. |
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.
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.
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.
A budget template may be requested by reaching out to erp@medtronic.com
Typical items that may be included in the Budget are:
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:
If requested, Medtronic may provide support in the form of product including the loan equipment.
Medtronic may provide limited technical support activities if, and to the extent, Medtronic has unique capabilities and expertise required for the study conduct.