Investigator Sponsored Studies
The ultimate goal of an Investigator Sponsored Study (ISS) is to advance clinical knowledge of Abbott Vascular products, related disease states, and various treatment options. This program is open to all academic and community-based physicians and researchers who are interested in conducting their own research. Abbott Vascular may fund or otherwise support scientific research, including ISS that are approved by the Scientific Review Committee (SRC)/Protocol Alignment Committee (PAC) in accordance with company standards.
Applications are evaluated based upon a variety of factors, including: scientific merit, feasibility to complete the study and publish results, consistency with the strategic focus for the product or compound being studied, originality of the proposal, and fair market value. The SRC/PAC will also evaluate whether an applicant is qualified to receive support for an ISS based upon the following factors, which include, but are not limited to: appropriate credentials, education, reputation, demonstrable relevant expertise, research background and training, knowledge of disease or therapeutic area in which the research will be conducted, debarment, disqualification, exclusion, disciplinary action or pending disciplinary action by any regulatory authority or any professional licensing body, ability and potential to successfully conduct the research for which the funds are requested (including staffing and site resources).
Investigator Sponsored Studies Research Agreement Guidelines
Concept Document and Protocol Submission Procedures
Investigator Sponsored Studies Research Agreement Guidelines
- Abbott Vascular will not provide, or be responsible for, funding or other support of any ISS Study until a complete application has been approved by the SRC/PAC, and upon execution of a mutually agreeable Research Agreement (contract).
- ISS applicants must submit to Abbott Vascular an ISS study budget or request for support that is consistent with fair market value of procedures being conducted.
- ISS applicants are required to provide a final study report/abstract, poster presentation, or manuscript submission within a specified period of time after the completion of study (as stated in the executed Research Agreement).
- The ISS applicant (Sponsor-Investigator) is solely responsible for and has full control over the ISS study. Abbott Vascular does not hold any responsibility or liability for the initiation, implementation, conduct, monitoring, analysis, or reporting of results. Note: While Abbott Vascular may fund a particular study and/or provision of the study device as noted above, Abbott Vascular may be contacted to verify its device specifications, technology, regulatory status, safety and effectiveness, or any other fact relating to its products.
- The Sponsor-Investigator is responsible for the recruitment of appropriate research participants and the conduct of the ISS in accordance with applicable legal and regulatory requirements.
- The Sponsor-Investigator is required to prepare and execute on the approved protocol, and comply with all applicable laws and regulations associated with serving as the Sponsor for a Clinical Study.
Concept Document and Protocol Submission Procedures
All ISS applications are processed as follows:
- Applicant completes the Abbott Vascular ISS Application via the Visiontracker™ online submission system.
- AV representative verifies that the Applicant has correctly completed all components of the application and then forwards the Request to the applicable Committee for review.
- AV representative notifies Applicant whether ISS support has been either approved or denied, or if modifications to the proposal are needed warranting further discussion with Sponsor-Investigator.
- If application is approved, AV representative oversees the process of generating a written Research Agreement between Abbott Vascular and the applicable requesting organization.
- Upon Research Agreement execution, AV representative arranges for issuance of payment(s) and/or device supply as per contract requirements.
- Sponsor-Investigator will provide AV with periodic study updates and a final study report per Research Agreement terms.
Submit a Concept Document or Protocol
VisionTracker™ is a web application being used by Abbott Vascular for the collection and tracking of ISS submission materials. When clicking on the link below, you will be re-directed to the Abbott Vascular VisionTracker™ website. For first time users, you will be required to register for a new account in order to access the VisionTracker™ system. Once you have completed your registration, you will receive two separate emails, one containing your unique username, and one containing your password. Once you receive both emails, you can login to the Abbott Vascular VisionTracker™ system and submit an application.
Eligibility of Organizations
Eligible Organizations include, but are not limited to:
- National/regional medical/scientific organizations
- Universities (teaching institutions or hospitals)
- Private Practice Institutions
Ineligible Organizations include, but are not limited to:
- Individuals or organizations debarred/disqualified by any Regulatory Authority or federally excluded individuals or organizations
- Individuals or organizations with disciplinary action or pending disciplinary action by any professional licensing body
- Individuals not affiliated with an eligible organization
AP2929135 Rev. A
