外部，外部
Research
程序，程序

Healthcare Professionals

Overview

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

The Medtronic External Research Program supports aglobal 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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Log in to manage，review，or submit your research proposal。

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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 asmall 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:Ifthere is aquestion regarding where a request falls within the External Research Program or a general research grant，please refer to table below orcontact us。

请求，请求

请求has protocol
and，andhas individual Sponsor-Investigator
and，andis focused on Medtronic product/service/therapy

是

请求falls within the External Research Program

否

预应力预应力混凝土，预应力养护grants and donations。

定义，定义

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，orused by a subject。His/her obligations include both those of a sponsor and those of an investigator。

Note:Theterm is usually replaced with investigator。It excludes any people other than 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 responsibility

  • 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，oroutcomes of these studies。

The chart below high lights examples of some potential differences between an industry-sponsored and an investigator-sponsored study。

Industry sponsored Investigator sponsored

协议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。

数据，数据

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）。

监视，监视

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。

英特尔ectual property

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

The intellectual property rights may vary by study。

德利verables

Usually determined by the company。

The investigator and company determine as part of research agreement negotiations。

发布，发布

The company and steering committee determine authorship。

The investigator determines authorship。

接触变形

（ERP），pleasecontact us。