External
Research
Program

Healthcare Professionals

Overview

Thank you for your interest in the Medtronic External Research Program (ERP).

The Medtronic External Research Program supports a global network of investigator-sponsored research projects in the spirit of advancing scientific and clinical knowledge related to our products and therapies, with the goal of improving patient care and clinical outcomes.

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About the External Research Program

Today, clinical evidence has become increasingly important in helping foster revolutionary change that advances medicine. Medtronic supports a small but important part of this need for clinical evidence through the External Research Program. The External Research Program is open to all Sponsor-Investigators who are interested in applying for support of their independently developed research.

Note: If there is a question regarding whether a request falls within the External Research Program or a general research grant, please refer to table below or contact us.

Request

Request has protocol
and has individual Sponsor-Investigator
and is focused on Medtronic product/service/therapy

Yes

Request falls within the External Research Program

For more information about general research grants, please visit grants and donations.

Definitions

Sponsor	Principal Investigator	Sponsor-Investigator
A company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study.	An individual who is responsible and accountable for conducting the study at a study site. The Principal Investigator 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.	An individual who both initiates and conducts, alone or with others, the study at a study site, and under whose immediate direction the study product, if applicable, is administered to, dispensed to, or used by a subject. His/her obligations include both those of a sponsor and those of an investigator. Note: The term is usually replaced with investigator. It excludes any people other than an individual (i.e., not a corporation or an agency).

Sponsor

Principal Investigator

Sponsor-Investigator

A company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study.

An individual who is responsible and accountable for conducting the study at a study site. The Principal Investigator 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.

An individual who both initiates and conducts, alone or with others, the study at a study site, and under whose immediate direction the study product, if applicable, is administered to, dispensed to, or used by a subject. His/her obligations include both those of a sponsor and those of an investigator.

Note: The term is usually replaced with investigator. It excludes any people other than an individual (i.e., not a corporation or an agency).

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

Roles and responsibilities

The Sponsor-Investigator of an ERP study assumes the roles and responsibilities of the study sponsor, including compliance with all regulatory requirements, including securing regulatory and institutional approvals as necessary.
The Sponsor-Investigator is responsible for conducting the study and assuring the validity of the study data.
Medtronic is a potential “supporter” of ERP studies but is not the study “sponsor.” As a result, Medtronic will not direct the design, conduct, or outcomes of these studies.

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 to ensure the integrity of the data.	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.
Deliverables	Usually determined by the company.	The investigator and company determine as part of research agreement negotiations.
Publication	The company and steering committee determine authorship.	The investigator determines authorship.

Contact information

For any questions regarding the External Research Program (ERP), please contact us.