The Program for the Protection of Human Subjects (PPHS) tracks completion of training electronically. Principal Investigators (PIs) and research staff can access training completion records and certifications from the CITI Program and PEAK websites.

Training Cannot Be Transferred

CITI and other non-CITI training completed at another institution will not be accepted at Icahn School of Medicine at Mount Sinai (ISMMS).

CITI Program Training

Required For

Investigators and all members of the research team working with human subjects are required to take the following CITI courses:

  • Human Subjects Research (Basic)
  • Data Security and HIPAA Training
  • HIPAA Update
Note

GCP Training – Investigators and staff who are required to complete Good Clinical Practice (GCP) training have the option of taking the GCP training module (GCP for Clinical Investigational Drugs and Biologics) through the CITI Program. Alternatively, training can be obtained by attending a GCP training session provided by the Research Compliance and Education Program. For more information, see Good Clinical Practice (GCP).

HIPAA Training – The CITI HIPAA Training modules are research related and are not the same as the Annual Mandatory HIPAA Refresher training required for all Health System faculty and staff in PEAK.

When

Training must be completed prior to IRB submission.

Access Instructions

  • Set up your account
    • Click here for step by step CITI registration instructions.
    • To set up your account, follow the instructions below:
      • Click “Register” on the CITI Home Page
      • Select “Icahn School of Medicine at Mount Sinai (SSO)” as your Organization Affiliation
      • Select “Continue” to SSO Login/Instructions
      • Use your Mount Sinai email address, your name recognized by HR, and your Life Number (or it’s equivalent) to your profile. This is essential to ensure that your record of completion electronically populates into your Sinai Central profile.
  • Register for required ISMMS training modules
    • Log in to CITI Program
    • Click the link “Add a Course or Update Learner Groups” for ISMMS
    • Add the course(s) you need to complete and click “Submit”.
      • Human Subjects Research (Basic or Refresher) – Note: Basic Course must be taken before the Refresher even if you took the Basic course at your previous institution.
      • Data Security and HIPAA Training
      • HIPAA Update

Affiliating Your Existing CITI Account with ISMMS

To affiliate your existing CITI account with ISMMS follow the steps below:

  • Log in to CITI Program.
  • Select “Click here to affiliate with another institution”, and select “Icahn School of Medicine at Mount Sinai”.
  • Enter your work email account, your name as recognized by HR and your life number (or its equivalent) in the CITI profile page.  This is essential to ensure your training certifications automatically populate into your Sinai Central profile.
  •  Add the course(s) you need to complete and click “Submit”.
    • Human Subjects Research (Basic or Refresher)
    • Data Security and HIPAA Training
    • HIPAA Update

Refresher

Every 3 years – Complete “Refresher Course” on CITI

Reference Guide

CITI Program Getting Started Video

Questions

Contact PPHS at IRB@mssm.edu or (212) 824-8200.

CITI Program Training - Rigor, Reproducibility, and Ethical Behavior in Biomedical Research

What

CITI Program Training Module – Rigor, Reproducibility, and Ethical Behavior in Biomedical Research

Required For

Faculty, fellows, residents and students

When

Faculty, fellows, residents and students must show completion when submitting an IRB protocol.

Access

  • Set up your account
    • Click here for step by step CITI registration instructions.
      • To set up your account, follow the instructions below:
      • Click “Register” on the CITI Home Page
      • Select “Icahn School of Medicine at Mount Sinai (SSO)” as your Organization Affiliation
      • Select “Continue” to SSO Login/Instructions
      • Use your Mount Sinai email address, your name recognized by HR, and your Life Number (or its equivalent) to your profile. This is essential to ensure that your record of completion electronically populates into your Sinai Central profile.
  • Register for required ISMMS training modules
    • Log in to CITI Program
    • Click the link “Add a Course or Update Learner Groups” for ISMMS
    • Add the course(s) you need to complete and click “Submit”.
      • Rigor, Reproducibility, and Ethical Behavior in Biomedical Research (Required for faculty, fellows, residents and students)

Affiliating Your Existing CITI Account with ISMMS

To affiliate your existing CITI account with ISMMS follow the steps below:

  • Log in to CITI Program.
  • Select “Click here to affiliate with another institution”, and select “Icahn School of Medicine at Mount Sinai”.
  • Enter your work email account, your name as recognized by HR and your life number (or its equivalent) in the CITI profile page.  This is essential to ensure your training certifications automatically populate into your Sinai Central profile.
  •  Add the course(s) you need to complete and click “Submit”.
    • Rigor, Reproducibility, and Ethical Behavior in Biomedical Research (Required for faculty, fellows, residents and students)

Reference Guide

CITI Program Getting Started Video

Good Clinical Practice (GCP)

Required For

Researchers and staff conducting FDA-regulated research as well all NIH-funded clinical investigators and clinical trial staff. For more information, refer to the NIH’s Definition of a Clinical Trial and Good Clinical Practice Training.

GCP Training – Industry Sponsored Clinical Trials & other Funding Agencies
Industry sponsors often require GCP training for investigators and the research team. Check with your funding agency regarding their GCP requirements.

When

Training must be completed prior to IRB submission.

Training Options

Investigators and members of the research team must complete either PEAK or CITI Program training modules.

PEAK Training Access

CITI Program Training Access
CITI CGP Training Module: GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)

Refresher

Refresher is recommended at least every 3 years.

Clinical Research Billing Rules for Investigators

Required For

Investigators who are conducting a project that requires a Medicare Coverage Analysis (MCA).

When

Training must be completed prior to IRB release of approval.

Why

The Centers for Medicare and Medicaid Services (CMS) mandate that protocol required clinical services paid for by the sponsor cannot be billed to subject insurance. The MCA defines which clinical services are insurance billable and which will be paid for by the sponsor.

Access Instructions

  • Open Research Online Course in PEAK.
  • Select Clinical Research Billing Rules for Investigators from the list of options.

Re-certification

Not Required.

Epic

Required For

Required for all individuals using Epic, including chart review (view only access).

Access Instructions

Visit the Epic Learn Center in PEAK for information regarding the training requirements based on your role. Requests for Epic access must be granted by your Department Administrator via Sailpoint prior to taking PEAK training. Access to Epic will be provided approximately 5 days after completing PEAK training.

Biosafety Training

Based on the role, responsibilities and potential exposures, the following Biosafety training may be required:

Questions: Environmental Health & Safety –  AskEHS@mssm.edu or (212) 241-7233 (x4SAFE)

Radiation Safety Training

Based on the role, responsibilities and potential exposures, the following training may be required:

Questions: Radiation Safety Office (RSO) – (212) 241-2269