What Is Required for an Initial/New Submission

Version: 4.2014

Program for the Protection of Human Subjects

Mount Sinai School of Medicine and Mount Sinai Hospital

One Gustave L. Levy Place, Box 1081

New York, NY 10029

Phone: 212-824-8200

Fax: 212-876-6789

Email:

PPHS E-Submission Checklist

Please use the corresponding lists to determine what items you are required to submit for your transaction.

You can obtain an IF number by beginning the FCOI declaration process in Sinai Central. You will be given a GCO number by beginning the process with the GCO office. Please note – these are separate processes required by the institution for any research project. If you have questions about these components of your review, you must contact the associated offices.

Please submit all required items in one submission to the IRB inbox at . When sending your submission to , please do the following:

-In the subject line, include: “HSM#/GCO#/Type of Submission/PI’s last name/Department

-Attach each document to the e-mail individually

-Label the HRP documents as: 211, 212, 213, 502, 503

-When submitting tracked and clean documents, adjust the labeling by inserting “tracked” or “clean” after the form #

Please note – all items that require “stamping” by the IRB (such as advertisements and consent documents) need to be submitted as Word documents.

Your submission will be assigned to an analyst, and you will receive an email within five days. This email may contain the project’s status or additional clarifications required before the project can be sent for official review, either by Non-Committee Review or Convened IRB.

Version: 4.2014

In general, the following are required for an initial/new submission:

HRP-211, Application Form

Appendix A: External Site Approvals (if any)

Appendix B: Drug/Biologics form (if any)

Appendix C: Device Form (if any)

IND or IDE documentation (FDA correspondence)

HRP-503, Protocol Template

Sponsor Protocol (if any)

HRP-502, Consent Form. If study includes children or incapacitated adults, include all applicable consent form templates

HRP-507, Consent for HIV Testing in Research (if applicable)

Package Inserts and/or Investigator’s Brochure for any drugs used in the study

Device Brochure (if any)

Patient/subject recruitment materials (if any)

HIPAA waiver request (if applicable)

Survey or assessment materials (if applicable)

CV’s, Resume, or NIH biosketch for all study personnel involved in the design, conduct or reporting of the research

All study personnel involved in the design, conduct or reporting of the research will need to complete their education requirements through www.citiprogram.org (affiliate with Icahn School of Medicine at Mount Sinai). The PPHS office does not require copies of certificates.

All study personnel will need to complete their conflict of interest declarations through Sinai Central (before submission to the PPHS office). [http://sinaicentral.mssm.edu/]

A submission to the GCO [212-824-8300], made through InfoEd, is required for all new studies after IRB submission is made [https://eresearch.mssm.edu].

In general, the following are required for a continuation submission:

HRP-211, Application Form

Appendix A: External Site Approvals (if any)

Appendix B: Drug/Biologics form (if any)

Appendix C: Device Form (if any)

HRP-212, Continuation Form

HRP-213, Modification Form (if any changes

are at this time being made to the study)

HRP-503, Protocol template – tracked (if

any changes are being made) and clean

Sponsor Protocol (if any)

HRP-502, Consent form(s) – tracked (if any changes are being made), previously approved, and clean (only if the study remains open to enrollment)

HRP-507, Consent for HIV Testing in Research (if applicable)

IND or IDE documentation (FDA correspondence)

Package Inserts and/or Investigator’s Brochure for any drugs used in the study

Device Brochure (if any)

DSMB report (if any)

Adverse Event report (if any)

CV’s, Resume, or biosketch of only those study personnel being added to the study (if any)

Patient/subject recruitment materials (if any, previously approved and clean if still needed)

All study personnel involved in the design, conduct or reporting of the research will need to complete their education requirements through www.citiprogram.org (affiliate with Icahn School of Medicine at Mount Sinai). The PPHS office does not require copies of certificates.

All study personnel will need to complete their conflict of interest declarations

annually for each study through Sinai Central (before submission to the PPHS office)[http://sinaicentral.mssm.edu/]

A submission to the GCO [212-824-8300], made through InfoEd, is required for all

continuing studies. [https://eresearch.mssm.edu]

In general, the following are required for a modification submission:

HRP-213, Modification Form

HRP-503, Protocol template – tracked, if applicable

HRP-502, Consent form – tracked and clean (must be word doc) if applicable

All other documents affected by the modification

In general, the following are required for a submission for an exemption determination:

Exempt Application Form

If Accessing PHI, HIPAA waiver request

Research Information Sheet or consent as applicable

Survey, measure materials as applicable

All study personnel involved in the design, conduct or reporting of the research will need to complete their education requirements through www.citiprogram.org (affiliate with Icahn School of Medicine at Mount Sinai) before initiating research activities. The PPHS office does not require copies of certificates.

All study personnel will need to complete their conflict of interest declarations

for each study through Sinai Central. [http://sinaicentral.mssm.edu/]

A submission to the GCO [212-824-8300], made through InfoEd, is required for all research. [https://eresearch.mssm.edu]