A concept submission is an abbreviated External Research Program (ERP) proposal which requires site and investigator contact information, a study summary and intended support requested. A concept submission is not required but is highly encouraged and allows for a Medtronic assessment of study interest/feasibility prior to the Sponsor-Investigator investing substantial time into a study protocol. If the proposal is conditionally approved at the concept stage, a full submission research proposal is required. Please note the final support decision is made on the final protocol and budget, not the concept submission alone.
A full submission proposal may be completed in place of a concept submission if a completed protocol and full study details are available at time of research submission. A version-controlled protocol, investigator curriculum vitae (CV), detailed study budget, if requesting support, and full submission proposal are required and will be reviewed by the Medtronic ERP board for final decision.