≡ Menu

Submit a Study

Investigators do not need to have a specific research project in mind before submitting their credentials to the ICARE office. Representatives can use the information provided to help find an interesting project for any investigator interested in research. However, feel free to forward any outside protocols to ICARE for approval. Representatives will help facilitate submission and administrative review on your behalf.

Before getting started ICARE asks that investigators print a copy of the attached to act as a guide for gathering the appropriate materials.

Study Submission Checklist
IRB’s Guide to Writing a Protocol

Required Forms

Investigators will be required to submit a copy of their current Curriculum Vitae, CITI training, and medical license to the research coordinator prior to the start of their first study. Investigators and their staff are also asked to sign a copy of the ICARE Confidentiality Agreement and Conflict of Interest Disclosure forms prior to starting their first study in an Steward Health Care facility. If these documents have already been sent to ICARE once in the last12 months then there is no need to resubmit.

The Clinical Trial Evaluation form is used to help identify any tests or procedures included in a research protocol that are beyond current standards of care. The CT Eval will help ICARE coordinate the use of Steward Health Care facility resources (space, equipment, supplies, personnel, etc.) in order to streamline study flow for the investigator. ICARE representatives will complete this form for the investigator based on the study protocol. Investigators will be asked to review the form and sign off on its contents prior to its formal submission to Steward Health Care administration.

A copy of the study protocol must be submitted to ICARE in order to complete this form. Contact ICARE for assistance.

Clinical Trial Evaluation Form
Conflict of Interest Disclosure Policy – Research
Conflict of Interest Disclosure Form – Research
Medicare Coverage Analysis Form
Confidentiality Agreement

Trial Start-up Services

Clinical Trial Agreement (CTA) and Budget

ICARE personnel are available to help negotiate clinical trial agreements between the sponsor and the Steward employed physician. Staff members are also available to facilitate price negotiations and study budget analysis for both Steward employed and non-employed physicians. Please forward a copy of the CTA and Budget to ICARE for further information.

Regulatory and IRB Submissions

Investigators are invited to contact ICARE for assistance in the completion of regulatory and IRB paperwork. ICARE representatives are available to help complete these documents. ICARE requires that Investigators use the ICARE Subject Injury Language in the final IRB approved copy of the Informed Consent Form (ICF) for all studies. Please forward a copy of the approved ICF as well as any requests for regulatory submissions to ICARE.

ICF Injury Statement

Contract Signature Process

ICARE asks that all Investigators follow the attached procedures when routing their final Clinical Trial Agreements and Service Agreements for signature.

Contract Signature Process

For more information, please contact us.