External Research Program (ERP)

External Research Program (ERP) is sponsored by Medtronic. This opportunity supports mission-aligned projects and measurable outcomes.

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Inclusion, Diversity & Equity Investigator Sponsored Research Program Investigator Sponsored Research Program <span class=\"text-heading-large\">Overview</span></h2>\r\n<p><strong>Thank you for your interest in the Medtronic Investigator Sponsored Research Program (ISR).

<br>\r\n</strong></p>\r\n<p>The Medtronic Investigator Sponsored 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.

</p>\r\n"}}" id="text-207f69c7da" class="cmp-text"> Thank you for your interest in the Medtronic Investigator Sponsored Research Program (ISR). The Medtronic Investigator Sponsored 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.

<span class=\"text-heading-large\">About the Investigator Sponsored Research Program</span></h2>\r\n<p>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 Investigator Sponsored Research Program.

The Investigator Sponsored Research Program is open to all Sponsor-Investigators who are interested in applying for support of their independently developed research. <br>\r\n<br>\r\nNote: If there is a question regarding whether a request falls within the Investigator Sponsored Research Program or a general research grant, please refer to table below or <a href=\"mailto:isr@medtronic. com\">email us</a>.

</p>\r\n<table width=\"100%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\">\r\n<tbody><tr><th rowspan=\"2\" style=\"vertical-align: middle;\">Request</th>\r\n<td rowspan=\"2\" style=\"vertical-align: middle;\">Request has protocol<br>\r\n<strong>and</strong> has individual Sponsor-Investigator<br>\r\n<strong>and</strong> is focused on Medtronic product/service/therapy</td>\r\n<td><strong>Yes</strong><br>\r\nRequest falls within the Investigator Sponsored Research Program</td>\r\n</tr><tr><td><strong>No</strong><br>\r\nFor more information about general research grants, please visit <a href=\"https://www.

medtronic. com/en-us/our-company/governance/grants-donations/medtronic-charitable-donations. html\" target=\"_blank\" rel=\"noopener\">grants and donations</a>.

</td>\r\n</tr></tbody></table>\r\n"}}" id="text-4a61960a3e" class="cmp-text"> About the Investigator Sponsored 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 Investigator Sponsored Research Program.

The Investigator Sponsored 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 Investigator Sponsored Research Program or a general research grant, please refer to table below or email us .

and has individual Sponsor-Investigator and is focused on Medtronic product/service/therapy Request falls within the Investigator Sponsored Research Program For more information about general research grants, please visit grants and donations .

<span class=\"text-heading-large\">Definitions</span></h2>\r\n<table border=\"1\">\r\n<tbody><tr><th>Sponsor</th>\r\n<th>Principal Investigator</th>\r\n<th>Sponsor-Investigator</th>\r\n</tr></tbody><tbody><tr><td>A company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study.

</td>\r\n<td>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.

</td>\r\n<td>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. <br>\r\nNote: The term is usually replaced with investigator.

It excludes any people other than an individual (i.e., not a corporation or an agency). </td>\r\n</tr></tbody></table>\r\n<p><br>\r\nNote: The regulatory and legal definitions and associated indicators of sponsorship may vary by geography. </p>\r\n"}}" id="text-2458bea2e1" class="cmp-text"> 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.

<span class=\"text-heading-large\">Roles and responsibilities</span></h2>\r\n<ul>\r\n<li>The Sponsor-Investigator of an ISR study assumes the roles and responsibilities of the study sponsor, including compliance with all regulatory requirements, including securing regulatory and institutional approvals as necessary. </li>\r\n<li>The Sponsor-Investigator is responsible for conducting the study and assuring the validity of the study data.

</li>\r\n<li>Medtronic is a potential “supporter” of ISR studies but is not the study “sponsor. ” As a result, Medtronic will not direct the design, conduct, or outcomes of these studies. </li>\r\n</ul>\r\n<p>The chart below highlights examples of some potential differences between an industry-sponsored and an investigator-sponsored study.

</p>\r\n<table cellpadding=\"1\" cellspacing=\"0\" border=\"1\">\r\n<tbody><tr><td> </td>\r\n<th>Industry sponsored</th>\r\n<th>Investigator sponsored</th>\r\n</tr><tr><th>Protocol ownership</th>\r\n<td>The company owns the protocol and invites investigators to participate. </td>\r\n<td>The investigator owns the protocol and can submit to multiple funding sources for support.

</td>\r\n</tr><tr><th>Data</th>\r\n<td>The company manages data with subject consent; the investigator typically has access to their data only. </td>\r\n<td>The investigator manages data with subject consent and gives company rights to use the data (if applicable). </td>\r\n</tr><tr><th>Monitoring</th>\r\n<td>The company is responsible for conducting appropriate monitoring to ensure the integrity of the data.

</td>\r\n<td>The investigator is responsible for study conduct and data validity. </td>\r\n</tr><tr><th>Intellectual property</th>\r\n<td>The company typically has rights to all intellectual property developed from the study data. </td>\r\n<td>The intellectual property rights may vary by study.

</td>\r\n</tr><tr><th>Deliverables</th>\r\n<td>Usually determined by the company</td>\r\n<td>The investigator and company determine as part of research agreement negotiations</td>\r\n</tr><tr><th>Publication</th>\r\n<td>The company and steering committee determine authorship. </td>\r\n<td>The investigator determines authorship.

</td>\r\n</tr></tbody></table>\r\n"}}" id="text-29c94fb801" class="cmp-text"> Roles and responsibilities The Sponsor-Investigator of an ISR 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 ISR 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. The company owns the protocol and invites investigators to participate. The investigator owns the protocol and can submit to multiple funding sources for support.

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). 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. The company typically has rights to all intellectual property developed from the study data. The intellectual property rights may vary by study.

Usually determined by the company The investigator and company determine as part of research agreement negotiations The company and steering committee determine authorship. The investigator determines authorship. Contact information</h2>\r\n<p>For any questions regarding the Investigator Sponsored Research Program (ISR), please <a href=\"mailto:isr@medtronic.

com\">email us</a>. </p>\r\n"}}" id="text-e28a0b92dd" class="cmp-text"> For any questions regarding the Investigator Sponsored Research Program (ISR), please email us . There are items that require your attention.

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