CITI Program and iRIS (IRB) Interface Information

Saturday, June 9, 2018

With the implementation of the iRIS system, there is now a direct interface between the CITI Training System and the iRIS System utilized by the DUHS IRB.

This is new for the research community, in that in the previous eIRB system CITI data went through a manual upload process and was not dynamically attached with Key Personnel data.

As the new interface is going live, there are several key points study teams should be aware of:

  • Please make sure that all members of your study team are up to date on all of their CITI training.  This includes both the Duke Health Good Clinical Practice (GCP) modules and the Vulnerable Population modules. The Vulnerable Populations Modules are not new requirements for Duke Health.
  • Vulnerable Population modules only need to be taken one time to be recorded as complete.  However, they must have been taken in order for study teams to add Key Personnel to a study and request KSP changes.  The DUHS IRB will check to make sure that all study team members have completed both Vulnerable Population Modules as well as Duke Health GCP modules.
  • In order for iRIS to attach CITI training to a user profile, the user must log into the iRIS System with their net ID and password at least one time.  If your users experience an issue with training validation, ask study team members to log into the iRIS system at least once.
  • In some cases, users have a different email address registered with their CITI account than they are using with their iRIS account.  This can cause training validation errors.  If your CITI account has a different email address from your iRIS account, please contact DOCR Training for assistance.

For information regarding CITI training requirements and for a link to the CITI website, see the DUHS IRB website.