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.
Research Compliance - Good Clinical Practice in Research
Research Compliance provides a monthly example driven course on the basics of Good Clinical Practice in Research. Please contact Vivian Mitropoulou to Register – or look out for the announcement on the Listserv (you must be subscribed).
Transferring Training
Non-CITI training completed at another institution will not be accepted at Icahn School of Medicine at Mount Sinai (ISMMS). Some CITI modules may carry over from a past institution if the modules are also used at Sinai.
Affiliating an 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.
- Add the course(s) you need to complete and click “Submit”.
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
GCP Training – Investigators and staff may be required to complete Good Clinical Practice (GCP) training. 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.
Please refer to the PPHS Training and Education page.
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
Refresher
Every 3 years – Complete “Refresher Course” on CITI
Questions
Contact PPHS at IRB@mssm.edu or (212) 824-8200.
CITI Program - 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. Please also refer to the PPHS Training and Education.
When
Training must be completed prior to IRB submission.
Training
Investigators and members of the research team are required to complete CITI CGP Training Module: GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
Additional Information
Affiliating Your Existing CITI Account with ISMMS
Refresher
Refresher is recommended at least every 3 years.
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.
- Click here for step by step CITI registration instructions.
- 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)
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.
CITI Program Training – OSHA Bloodborne Pathogens
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) or Biological Safety Program – biosafety-program@mssm.edu.
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