As per the Northwell Health policy, GR085 Training Requirements for the Human Subjects Research Protection Program, all individuals involved in research with human subjects (investigators, coordinators, research assistants, etc.) must complete the following CITI Program courses:
- Northwell Health Human Subjects Research Course (must be renewed every 3 years)
- Conflict of Interest Course (must be renewed every 4 years)
In addition, the following CITI Program courses are also required prior to IRB approval if applicable to the human subject research:
- Humanitarian Use Devices (HUDs) – required to be completed once for all physicians and their staff who are listed on the IRB HUD Application as using a HUD within its approved labeling which does not constitute research.
- Good Clinical Practice (GCP) Training – must be renewed every 3 years and is required for: a) all sponsor-investigators and key personnel working on sponsor-investigator trials, and b) all NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. Available GCP training options include:
- CITI Program Good Clinical Practice Course (Sponsor-Investigator Responsibilities)
- 2-Day Navigating Clinical Research at Northwell Health class
- TransCelerate Member GCP Courses (Please send documentation to RPT@northwell.edu for review and approval.)
- TranCelerate GCP Training Provider Approved Courses (Please send documentation to RPT@northwell.edu for review and approval.)
- NIH Recombinant DNA Guidelines; Basic Biosafety Training; Select Agents, Biosecurity, and Bioterrorism; and Dual Use Research of Concern – must be renewed every 3 years and are required for research investigators and research staff involved in human subject research with biological agents or toxins, select agents, or dual use research of concern. For more information, click here.
Accessing CITI Program
Click here to watch a video tutorial on how to register as a new user, affiliate with Northwell Health as an existing user, and to add a course or update your learner group in CITI. More information and detailed instructions on accessing the CITI Program can be found by clicking here.
Training Completion Dates – click this link to find CITI Program training completion dates for Northwell Health.
Additional Training Opportunities
It is highly recommended that clinical researchers also take advantage of the optional courses that are available. For guidance on other optional research training that may benefit your research team, click here.
Please email the Office of Research Policy and Training at RPT@nshs.edu with any questions, concerns, or suggestions.