Investigator Initiated Study Request

Overview

ACIST Medical Systems, a Bracco Group company is committed to improving patient care through support of scientific advances in medicine and increasing understanding of important diseases. As part of this commitment, the Investigator Initiated Sponsored Research (IISR) program supports innovative clinical and basic science studies that address important medical and scientific questions related to our devices and therapeutic areas of interest.

IISR is defined as unsolicited, independent research where the investigator or the institution (academic, private, or governmental) serves as the Sponsor and the company provides support in the form of study device and/or funding.

IISR proposals are reviewed by the company’s Clinical Science Funding Committee. Decisions are based upon scientific merit as well as alignment with research areas of interest and availability of resources.

Support for an IISR is awarded strictly based on research merit criteria. Support of a study in no way implies any obligation toward or is any way connected to the recommendation or purchasing or prescribing of companyproducts.

Investigator Sponsor Responsibilities

• Compliance with all laws governing clinical research, patient privacy, healthcare compliance and other applicable regulations and guidance.
• Obtaining all necessary approvals prior to the start of the research study within a reasonable timeframe.
• Registering the study and results on a public website such as www.clinicaltrials.gov when appropriate.
• Maintaining proper staffing to complete the study as defined by the predetermined study schedule.
• Conducting proper monitoring of the study.
• Ensuring that neither patients nor payers are charged for product provided by thecompany.
• Obtaining conflict of interest clearance for the research study and investigators as needed.
• Design of the study and creation of a clinical budget to support the project.
• Implementation of the study in accordance with the agreed upon study protocol, budget and contract.
• Attainment of study milestones in accordance with the agreed upon study schedule.
• Submission of, at a minimum, quarterly study status updates to the company.
• Obtaining Institutional Review Board/Ethics Committee/Institutional Animal Care and Use Committee approval or documented waiver, prior to the start of the study.
• Disclosure of all conflicts of interest related to the study, (i.e. financial or ownership conflicts).
• Assuring patient enrollment is progressing as defined in the final protocol and/or contract.
• Statistical and data analysis for all defined endpoints for interim and/or final publications.
• Reporting safety data to the appropriate regulatory body, IRB/EC, and the company as described in the contractual agreement and local laws.
• Providing the company with a draft manuscript, abstract, and/or poster presentation in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines, when appropriate, upon study completion. This draft is to be submitted for publication per the previously agreed upon publication plan and in accordance with the schedule detailed in the grant agreement.
  
  

 Company Responsibilities

ACIST Medical Systems, a Bracco Group company may provide support in the form of product supply, technical support and funding.

Product Supply: If requested, the companymay provide support in the form of product, including the loan of equipment, during the time of the study.       

Technical Support: the companymay provide limited technical support activities in the event the company has unique capabilities and expertise required for the study conduct.

Financial Support: the company will consider funding activities related to both direct (subject-related costs, study-related personnel costs, diagnostic fees/services, medical writing, statistical support, external data management expenses etc.) and indirect (e.g. equipment and supply expenses) study costs as outlined in the study contract.

Study support for third-party resources to aid in the conduct of the study (i.e., research personnel, statistical support, medical writing) must be clearly defined in the contract and budget. If medical writing is required, the contract must clearly identify the use of this resource.  No funding will be provided until a mutually agreed upon contract and budget is in place.

 Studies Generally Supported by ACIST Medical Systems, a Bracco Group company

• Research in specific areas of interest to the company (see section “Areas of Interest” for current list).
• Studies with a reasonable sample size and follow-up timeline
• Studies may be clinical or non-clinical (benchtop, algorithm, cadaver or animal studies)
• Prospective and retrospective studies
• Well-designed studies having an appropriate statistical plan
• Studies having budgets that are of fair market value
  
  

Financial/Support Restrictions

 ACIST Medical Systems, a Bracco Group company will not provide compensation or support for the following:

• General education or training activities
• Support for ongoing clinical programs that are part of an organization’s routine operations
• Start-up funds to establish new clinical or research programs or to expand existing programs
• Purchase of capital equipment unrelated to the study or that would generate revenue
• Construction funds
• Hiring of staff that are not dedicated to the study
• Travel to conferences to present study results unless Physician is presenting on behalf of the company at sponsored symposiums/training
• Manuscript writing
• Publication preparation and submission
• Idea or protocol development
  
  

Topics of Current Interest to ACIST Medical Systems, a Bracco Group company

• Angiography
  • Contrast reduction/management
  • CVi in TAVR
  • Peripheral use of CVi
• Physiology
  • Peripheral use of Navvus
  • Coronary microvasculature studies
  • Pullback studies using Navvus (especially looking at resting indices, e.g. Pd/Pa)
  • Health & Economic data studies using RXi/Navvus
• Imaging
  • Comparison of traditional IVUS (20 MHz phased-array or 40 MHz rotational) to High-Definition IVUS
  • Comparison of OCT and High-Definition IVUS
  • Economic models for cost savings of IVUS-guided PCI
  • Stent optimization techniques using IVUS
  • Comparison of stent optimization using EEM versus luminal measurements
  • CHIP Case Studies
  • Peripheral use of HD-IVUS
• Diagnostic Imaging – focus on CT and MR injectors and contrast management
  • Personalized contrast protocols
  • Reduce contrast dose waste
  • Technologist/radiographer productivity
  • Sustainability of disposables
  • Economic models in contrast-based imaging

Submission Process

The Investigator Initiated Study process begins with the submission of an Investigator Initiated Sponsored Research (IISR) Initial Proposal Form, as well as a current Curriculum Vitae of the Investigator(s).  This form serves as a request for assistance and collects information needed to assess the scientific merit of the proposed study and is submitted toclinicalaffairs@acistmedical.com or via this website. 

A multi-functional review will be conducted to evaluate the proposal for scientific merit, regulatory compliance, and alignment with corporate objectives and budgetary scope to determine if the company would like to explore the proposed study idea.  If so, additional information required for a proposal submission will be requested so that funding can be considered.

Please note: An invitation to submit a full proposal for your research and does not guarantee support for the research from the company.

Initial Proposal Request – Required Documentation

• Completed Investigator Initiated Sponsored Research (IISR) Proposal Form
• Curriculum Vitae of the Principal Investigator
  
  

Full Proposal Request – Required Documentation

• Full study protocol
• Total funding requested (itemized and detailed)
• Curriculum Vitae of any sub-investigators expected to participate in the study
• Certification that no one to be involved in the investigation has been disqualified, debarred, or otherwise under investigation by a Regulatory or Institutional body
  
  

Clinical Science Funding Committee (CSFC) Review

Once submitted, your full proposal will be assessed by the CSFC 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.

A representative of the clinical department will convey the CSFC decision to the applicant, typically within 60 days of submission.

Research Agreement

If your proposal is approved by the CSFC, 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 the company.

Study Start Up

It is the responsibility of the Investigator/Sponsor to obtain the proper IRB/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 the company.)

Study Conduct

The Investigator/Sponsor is responsible for conducting the study in accordance with regulations and the executed Research Agreement, as well as assuring the validity of the study data and providing regular progress reports for the duration of the study to the company.

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

Study Completion

Upon completion of the study, the Investigator/Sponsor will submit the final deliverable to the company as per the Research Agreement.

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 the company.

Publication of Study Data

Any planned publication or presentation must be sent to the companyfor review of any claims, scientific validity, appropriate device use, etc. prior to journal submission as agreed upon in the agreement.