STEP I

Investigator Form (IF)

Sinai Central

The Investigator Form (IF) is used by the institution to manage potential conflicts of interest in research.

PROCESS
  • Principal Investigators or their delegates must submit the IF form in Sinai Central.
  • All study investigators must be listed on the IF form. Refer to the GCO Investigator and PPHS Investigator definitions.
  • Sinai Central generates a notification email to all study investigators requesting the submission of the FCOIR.
  • Sinai Central generates the IF#, or Sinai Central Project ID # used for the IRB/Ideate and GCO/InfoEd application.

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STEP II

Financial Conflict of Interest in Research (FCOIR)

Sinai Central

All investigators must disclose potential Financial Conflicts of Interest in Research (FCOIR) for all projects.

Failure to complete FCOIR Forms in a timely manner will DELAY research projects. The IRB and GCO will not accept applications until ALL FCOIR Forms are completed.

PROCESS
  • Sinai Central generates a notification email to all study investigators requesting the submission of the FCOIR Form.
  • Study investigators are required to complete FCOIR training every 4 years in PEAK.
  • Submission of the Annual Disclosure Form in Sinai Central.
  • Submission of the FCOIR Form in Sinai Central.

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STEP III

Start GCO Application

InfoEd

The Grants and Contracts Office (GCO) reviews studies for accuracy of administrative information and budget, as well as for compliance with Federal, State, New York City, and Icahn School of Medicine regulations.

PROCESS
  • Start the InfoEd (GCO) application to obtain the PD# required to submit an IRB application.
    • Note: The InfoEd application DOES NOT need to be submitted to get the PD#.
  • Submit the GCO application AFTER the IRB application submission.

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STEP IV

IRB Submission

Ideate

The ISMMS Institutional Review Board (IRB) is responsible for assessing and approving ALL research at the Mount Sinai Health System (MSHS) that is to be conducted on humans.

PROCESS
  • Submit request in the Ideate System.
  • The IRB submission should be concurrent with budget and contract negotiations. Final IRB approval is contingent on a fully-executed contract.
AVERAGE TURNAROUND TIME

Full Board projects: 27 business days from submission deadline to review at a meeting

Expedited projects: 25 business days from submission deadline to approval

2019 ISMMS IRB Review Deadlines & Board Meeting Dates

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Contracts & Budget Submission

MediTract

The Financial Administration of Clinical Trials Services (FACTS) office reviews, negotiates and executes all clinical research agreements funded or supported by For-Profit (Industry) Entities.

PROCESS
  • Submit Contacts & Budget to FACTS via the MediTract system
  • Contract negotiation should occur concurrently with budget negotiations and IRB review.

Avg Turnaround Time: 4 to 6 Weeks

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STEP V

GCO Submission

InfoEd

The Grants and Contracts Office (GCO) evaluates the accuracy of administrative information and budget, as well as compliance with Federal, State, New York City, and Icahn School of Medicine regulations.

PROCESS
  • PI and the study personnel should review the application checklist.
  • PI must approve and submit the application in InfoEd.

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