Albert Einstein College of Medicine of Yeshiva University

Jack & Pearl Resnick Campus

Belfer Educational Center for Health Sciences, Room 1002

1300 Morris Park Avenue, Bronx, NY 10461

Committee On Clinical Investigations Phone: (718) 430-2237

(Institutional Review Board) Fax: (718) 430-8817

Protocol Submission Checklist

Complete Collaborative Institutional Training Initiative (CITI) at http://www.citiprogram.org. See http://www.aecom.yu.edu/cci/page.aspx?id=9746 for more information.

Write the protocol. See the following two links for guidance:

§ Research Protocol Design Criteria – Outline of the required elements of research protocol design. http://www.aecom.yu.edu/cci/page.aspx?ID=9774

§ Protocol Element Checklist - To be used as a checklist guide in the review of your protocol, prior to submission to the Committee on Clinical Investigations. This document will assist the investigator in ensuring that all of the research protocol design criteria are met. http://www.aecom.yu.edu/cci/page.aspx?ID=9776

Attend a PATS Training. See the schedule, registration, and more information at http://www.aecom.yu.edu/cci/page.aspx?ID=9650

Determine review type. See the following links for guidance:

§ Exempt Research – http://www.aecom.yu.edu/cci/page.aspx?ID=9780

§ Expedited Research – http://www.aecom.yu.edu/cci/page.aspx?ID=9782

§ Full Review – http://www.aecom.yu.edu/cci/page.aspx?ID=9784

Complete Application

§ Exempt Application: See the definition of Exempt Research at http://www.aecom.yu.edu/cci/page.aspx?ID=9780

§ Chart Review/Database Study Application: Study Examples: Medical Records review, Hospital Databases, Public Database, Data Analysis, etc.

§ Behavioral/Observational Study Application: Study Examples: School based research, or research using Focus Groups or questionnaires, etc.

§ Specimen Study Application: No direct research intervention by PI. Study Examples: research on leftover specimens, identifiable previously collected specimens, prospective specimens, etc.

§ Clinical Research Study Application: Direct research intervention by PI. Study Examples: blood drawing, MRI’s, radioisotopes, drugs, or devices, etc.

Prepare recruitment tools/methods. These may include consent/assent forms, waivers of consent of written documentation of consent, Dear Parent/Participant letters, advertisements, etc.

Submit the materials for review. See http://www.aecom.yu.edu/cci/page.aspx?ID=9772 for submission requirement details.

CCI Process

§ Audit

§ Review

o Internet security verification

§ Approval

Receive approval letter – research may begin.

Ongoing Monitoring:

§ Amendments – Any changes to your protocol must be submitted to the CCI for review and approval.

§ Progress Reports – Annual updates regarding the status of the protocol are required for Full and Expedited Review protocols.

§ Research Records – The regulations require that research records must be maintained by the Investigator and stored for specific amounts of time.

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