Process and Submission External Research Program

PROCESS & SUBMISSION OVERVIEW

This Medtronic External Research Program (ERP) website is used to manage your research proposal through the entire process from submission to completion. As the Investigator/Sponsor of the study, you are responsible for all aspects of your study including the conduct of the research, Legal and Regulatory requirements.

Step 1: Review External Research Program (ERP)

For detailed information regarding the Medtronic External Research Program (ERP) submission process, roles and responsibilities and what to expect as the Investigator/Sponsor of the study go to: Medtronic External Research Program (ERP) Guidelines and FAQs.


Step 2: Register for an ERP Account to submit your proposal

Register for a User ID and Password for access to our online application.


Step 3: Concept or Full -Submission

A. Concept [Optional, if starting with a full submission, go to section B. below]:

Please provide a brief summary of your protocol and request for support from Medtronic.

Once your concept submission is reviewed, feedback will be provided. If your Concept Submission is approved, a full protocol and budget (if applicable), will be required for a more in-depth review. Please note that the final support decision is made on the full protocol and budget, not the Concept Submission alone.

B. Full Submission:

Please provide your full study protocol, detailed budget/product/support requested, and CV to Medtronic.


Step 4: Board Review

Once submitted, your proposal will be assessed by the ERP Review Board of the appropriate business unit at the next available review meeting. This cross functional team carefully assesses the details of the proposal including scientific soundness, safety, technical feasibility, budget alignment with Fair Market Value (FMV), and alignment with corporate strategies.


Step 5: Contracting

If your proposal is approved by the ERP Review Board, a research agreement will be drafted and negotiated with your institution. Support will be contingent upon full execution of a research agreement between your institution and Medtronic.


Step 6: STUDY START UP

It is the responsibility of the Investigator/Sponsor to obtain the proper Ethics Committee approval or waiver and regulatory submission approval as applicable prior to the start of the study with documentation (i.e. a copy of the approval letter(s) provided to Medtronic.)


Step 7: Active Study

The Investigator/Sponsor is responsible for conducting the study, assuring the validity of the study data and providing regular progress reports for the duration of the study to Medtronic.

If applicable, payments will be made upon the achievement of agreed-upon milestones as outlined in the Research Agreement.


Step 8: Final Deliverable

Upon completion of the study, the Investigator/Sponsor will submit the final deliverable to Medtronic as per the research ERP agreement. Medtronic shall be entitled to review all abstracts, publications and presentations prior to submission.


Step 9: Project Close

Upon completion of the study, reconciliation details and provision of any agreed-upon data sets or final reports/manuscripts must be completed and the project will then be closed out by Medtronic.


Step 10: Post-Project Close Out

If the research is published after the close out of the project, please submit copies of your abstracts, presentations and publications to Medtronic.


To gain access to our online application.