In addition to research-appropriate experience and qualifications, a working knowledge in the appropriate conduct of research is essential.
OSF HealthCare expects investigators and research staff to understand and comply with federal, state and local laws, regulations and guidance that apply to their research.
This is accomplished through continuous education and training resources offered through a variety of providers and methods.
OSF requires education/training for investigators and staff who will perform study related activities that include:
Federal regulations and OSF distinguish between the use of a HUD "in the practice of medicine” and HUD use "in a clinical trial."
HUD use in the “practice of medicine” means: treatment/diagnostic use of an HUD according to the FDA approved indication (on-label use); or not according to the FDA-approved indication (off-label use) when the use is for the well-being of a patient and not for research purposes.
Note: OSF does not require compliance with the CITI education policy for use of a HUD in the practice of medicine.
HUD use “in a clinical trial” means: Use in a clinical investigation to evaluate the effect of the intervention on human participants by collecting safety and effectiveness data.
Note: OSF requires compliance with the CITI education policy for use of a HUD in a clinical trial.
At a minimum, all investigators and staff participating in the conduct of research for OSF HealthCare are required to complete web-based training through the services of the Collaborative Institutional Training Initiative (CITI) Program .
CITI Program is a nationally recognized and well known resource for research education and training.
The CITI Program training courses required by OSF cover four core areas:
When conducting FDA regulated research or clinical trials funded by the National Institutes of Health (NIH), investigators and staff must complete Good Clinical Practice (GCP) training in addition to the three core areas mentioned above.
FDA regulated research includes, but is not limited to:
NIH-funded clinical trials are research studies that satisfy ALL of the following criteria:
CITI Program training through OSF also offers a number of voluntary supplemental courses in other areas of interest to researchers