Investigator Initiated Study Request

Overview

Overview

ACIST Medical Systems, a Bracco Group company is committed to improving patient care through support of scientific advances in medicine and increased 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 company products.

Studies Generally Supported by ACIST Medical Systems

Topics of Current Interest to ACIST Medical Systems

Angiography

Physiology

Imaging

Diagnostic Imaging – focus on CT and MR injectors and contrast management

Investigator Sponsor Responsibilities

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.

Financial/Support Restrictions

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

The Investigator Initiated Study process begins with the submission of an Investigator Initiated Sponsored Research (IISR) Initial Proposal Form, located at the bottom of this page, 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 to clinicalaffairs@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

Full Proposal Request – Required Documentation

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 company for review of any claims, scientific validity, appropriate device use, etc. prior to journal submission as agreed upon in the agreement.

ACIST Initial Proposal Submission Form Investigator Initiated Sponsored Research (IISR)

TITLE OF STUDY
GRANTEE INFORMATION
INVESTIGATORS
Lead PI Name:
Attach CV:
Site PI Names:
(if multi-site study)
Attach CV:
PROPOSED STUDY DETAILS (OR ATTACH SUMMARY)
Study Details:
Study Design (check all that apply):
REQUEST FOR SUPPORT
CLINICAL EVIDENCE DISSEMINATION PLAN
Will ICMJE recommendations be followed?

GENERAL CONDITIONS OF SALE