Frequently Asked Questions

Program Overview

What is a "sponsor-investigator"? Isn't Boston Scientific the sponsor?

A sponsor-investigator is a single individual or institution/foundation etc. (where permitted) that is responsible for fulfilling the obligations of both a study sponsor and an investigator.

The sponsor's role is not related to financial support, which is provided by a funding agency.

Roles and responsibilities in the ISR Program:

Funding Agency, Boston Scientific: Provides financial support/product for the study according to a defined Research Contract, which outlines milestones and specific deliverables
Sponsor, Physician/Institution: Oversees the conduct of the study, including document management, data management, data analysis, publication, FDA reporting, etc.
Investigator, Physician: Conduts the day-to-day research according to a defined protocol and per specified procedures

Is the program appropriate for me?

The program supports unsolicited, investigator-sponsored trials. This means that as the sponsor, you are entirely responsible for protocol design, statistical analysis, study registration, IRB (or local equivalent) approval, reporting of adverse events, and other sponsor responsibilities.

You will need a working knowledge of study design and management as well as applicable regulations for conducting research and good clinical practice (GCP) guidelines.

You will also need to ensure you have the resources available to conduct the trial (eg, personnel, equipment, time). For more information, visit www.fda.gov.

Study Management

Can the Research Committee or other Boston Scientific experts help me develop a protocol, statistical analysis plan, etc?

No. As part of the legal requirements, investigator-sponsored trials must be "unsolicited." Boston Scientific is allowed to post generalized areas of interest but cannot participate in study concept generation or protocol development.

Once the protocol is developed, the committee may ask questions to clarify the design or may offer general advice if the proposal needs more structure.

However, you must maintain your role as the author and owner of the project.

Who owns the data after the study has closed?

In most cases, unless otherwise specified, you or your facility will own the data.

Can the ISR Program manage a database for my research, run the statistical analysis, or participate in drafting of publications?

No. Boston Scientific cannot manage the study nor participate in data collection or analysis.

Can Boston Scientific control or prevent me from publishing results?

No, Boston Scientific would not delay or halt publication of results.

To protect intellectual property, you will be required to submit a draft prior to submission to a third party so Boston Scientific can request reasonable redrafting if proprietary information is revealed.

Study Overruns

What happens if my study is not progressing as originally anticipated?

If your study falls behind, requiring additional time, additional funding, or protocol changes, you will be asked to describe what has caused the change and what you believe can be done to get the project back on track.

The Divisional Research Committees will review the proposed changes and work with you to make a decision on remedial action.

Because study progress is documented in the research contract, an amendment is generally required.

If I have had a trial closed mid-study or have trials that are behind, does that preclude me from initiating additional projects with Boston Scientific?

Past performance will be considered. The Committee will look into any past and current projects and their status.

However, the Committee recognizes that a study might be closed or delayed for reasons beyond your control. Depending on the reason(s), it may decline to fund future projects, withhold a funding decision until outstanding issues are resolved, or determine that past closure or delay does not indicate future study performance.

Sponsor-Investigator Responsibilities

What is trial registration? Is it required and who is responsible for registering?

As a condition of publication, the International Committee of Medical Journal Editors (ICMJE) requires study registration prior to enrolling the first subject(s).

The party responsible for conducting the trial (either sponsor or principal investigator) must register the study. As that individual, it is your responsibility to get your study registered. To learn about trial registration, visit the National Institute of Health (NIH) protocol registration information website: https://prsinfo.clinicaltrials.gov/.

What are my responsibilities with respect to the FDA or equivalent local authorities?

The FDA or equivalent local regulators define specific responsibilities for physicians, investigators, and sponsors. You must understand the requirements for all of these roles.

Information on these requirements is available online in the FDA guidance on good clinical practice (GCP), Code of Federal Regulations (CFR) 21, the International Conference on Harmonisation (ICH) Guidance Documents, among other available documentation.