Duke Medicine currently uses the web-based modules available at the Collaborative Institutional Training Initiative (CITI) website (www.citiprogram.org) for certification in Human Subjects Protection (HSP) Training. The Clinical Research Support Office (CRSO) is responsible for tracking module completion.

All Duke Medicine clinical research personnel who participate in the conduct of research with human subjects (i.e. are responsible for the study design, data, or specimen collection or who contribute to the scientific development or execution of the study in a substantive, measurable way) need to fulfill this training requirement.
In addition, all Duke Medicine staff involved in the review, approval, or oversight of research involving human subjects also needs to complete this training.

All Duke Medicine personnel meeting the above criteria will initially complete six (6) CITI modules (see attached policy for the list of required modules). Satisfactory completion of a module requires a passing score of 80%. In addition to the above six (6) CITI modules, any Duke Medicine personnel involved in the conduct, review, approval or oversight of research with prisoners is required to complete the CITI module entitled "Vulnerable Subjects - Research with Prisoners." Any Duke Medicine personnel involved in the conduct, review, approval or oversight of research with children is required to complete the CITI module entitled "Vulnerable Subjects - Research with Children."

The CRSO will not accept training for Duke Personnel from other institutions unless the individual can provide documentation of CITI training as required by Duke Medicine. For personnel who conduct research at the Durham VA Medical Center, the CRSO has access to the current CITI training required by the Durham VA Research Office and accepts this as certification in lieu of Duke Medicine CITI module completion. This completion data will be uploaded into Duke Systems on a regular basis. For all other acceptable alternative training, please see the policy below.

 Questions can be directed to CRSO.Help@notes.duke.edu or 681-6665.   Please note: CME/CE and AMA credits are available through CITI. The individual must complete a minimum of 12 modules from the Human Subjects Research program (Basic or Refresher) to be eligible for credits. The individual has to apply personally for the credits for a cost ranging from $40 to $80 depending on the type of credits they are applying for and the module program completed. The CRSO will not be providing educational credits through a centralized portal within Duke Medicine.

Instructions for CITI module completion  Revised - 11.28.11

CITI module requirements for the Department of the Navy

Duke Medicine policy for HSP training

Frequently Asked Questions about CITI

Step-by-Step instructions to renew your CITI modules