GCO Submission

Instructions are provided for the Grants & Contracts Office InfoEd submission process, including steps to finalize and submit the application, contact information for the departmental assigned GCO specialist, and approval routing process.

Contracts & Budget Submission

Guidance on the submission process pertaining to For-Profit (Industry) clinical trial agreements to the Financial Administration of Clinical Trials Services (FACTS) Office. Further detail on budget development and negotiations are also provided.

IRB Submission

Information on the IRB submission requirements and process , including reference guides, deadline dates, ISMMS conditional office reviews (if applicable), as well as training and workshops offered at ISMMS to provide further guidance in the submission process.

Start GCO Application

Detailed checklists and instructions that guide researchers through the process of completing an InfoEd application for industry initiated clinical research studies.

Financial Interest in Research Disclosure Form

Instructions regarding how study teams can report any financial interests that pose actual or perceived conflicts with a proposed research study, including updated Federal Policies that can be referred to.

Submit the IF (Investigator Form), FCOIR (Financial Conflict of Interest in Research), and S&D (Suspension and Debarment) in Sinai Central:

Investigator Form (IF)

How to create an Investigator Form (IF) to manage potential conflicts of interest, including who needs to be listed or when it is required to be completed.

Annual Report of Outside Relationships (Annual Form)

All Mount Sinai principal investigators, co-investigators, mentors, and key personnel must complete an Annual Report of Outside Relationships (also called the Annual Form) disclosing all financial interests that they may have outside of employment at Mount Sinai.

Budget Development and Negotiation

Tips, tools and services offered by the Financial Administration of Clinical Trials Services (FACTS) Office to assist teams develop and negotiate budgets for industry sponsored clinical trials. Information regarding fee schedules and BRANY can also be accessed here.

Approvals Needed for Research

Refer to the list of institutional committees, Departments and Institutes that may require review and oversight based on the nature of the research study.

Conducting a Device Study

 Before You Begin Contact Inna Bender or Paulette Palmer for the specific procedures required for device trials. Medicare Approval for Investigational Device Exemption (IDE) Clinical Trials Medicare approval for IDE trials is a two-step process that includes:...