Frequently Asked Questions

External Research Program




Expand All

What is the difference between a concept submission and a full submission?

What type of information is needed to submit an application?

Does Medtronic provide research areas of interest?

Does Medtronic support Investigator-sponsored research using investigational devices?

Will Medtronic support a multi-center study?

For device studies, do patients need a Medtronic device/product for me to receive support? Can competitors’ devices be included?

Can end users access the ERP web application system using their iPad or iPhone?


Expand All

What is the review process and how long does it take?

What are the review criteria? 

Who will have access to my study proposal (confidentiality)?

What role does the Medtronic regulatory department play in my study review and approval?


Expand All

Who is the sponsor of Investigator-Sponsored research?

What is required in the study budget?

What is required for preparation of the contract?

Will a Medtronic representative monitor the data or case report forms (CRFs) for my study?

Who would be assigned the rights to a patent that is generated because of a Medtronic supported Investigator-Sponsored research?

Study start-up

Expand All

Does Medtronic require IRB/MEC/IACUC protocol approval?

How should the patient informed consent be developed?

Should I register my clinical study online?

Post study start-up

Expand All

When does Medtronic consider a study to be activated and provide initial payment? 

What are Medtronic's expectations for reporting on study progress?

Who is responsible for reporting study-related adverse events?

What happens if there is a change in the protocol or budget?

What should I expect if my study is delayed or has trouble with enrollment?

Can I publish my study results and do I need to inform Medtronic?

Is study-related compensation reportable under the Sunshine Act?

Contact information

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