Complete the training as directed on this page before submitting an application for review.

All research personnel, including faculty, staff, subcontractors, students, research supervisors, and unaffiliated investigators, must successfully complete training prior to conducting human subjects research at Western Carolina University.

WCU's training is offered through the CITI Program, which may be accessed at www.citiprogram.org.

• Detailed instructions for registering, affiliating with WCU, and selecting the correct course
• Downloading a CITI course completion report

Please note: Both the Social/Behavioral Research course and the Biomedical Research course will satisfy the training requirement. The Responsible Conduct of Research (RCR) course will not meet the training requirement.

The training requirement must be renewed every FIVE years. CITI will send an automated training renewal e-mail to each individual investigator when their training is about to expire. Investigators must have a current certification on file as a condition of study approval.

Good Clinical Practice (GCP) Training

Good Clinical Practice is the international ethical and scientific standard expected in the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. Compliance with GCP provides assurance that data are reported, results are credible and accurate, and that the rights, safety, confidentiality, and well-being of trial participants are protected.

NIH has issued a policy on GCP training for National Institutes of Health awardees involved in NIH-funded clinical trials. This policy requires that primary investigators and clinical trial staff involved in all new and ongoing NIH-defined clinical trials complete GCP training by Jan. 1, 2017. GCP principles help assure the safety, integrity, and quality of clinical trials by addressing elements related to trial design, conduct, and reporting.

The new NIH policy requires GCP training be refreshed every three years in order to remain current with regulations, standards and guidelines.

If you are involved in biological, drug or device research, as well as social and behavioral research you are required to complete the CITI GCP training for clinical trials involving drugs, biologics and devices. If you have taken the CITI GCP training for biologics and drugs and devices you do not have to take the additional social and behavioral GCP training if you are involved in social and behavioral research.

GCP training is in addition to (and different from) human subject protection training, which is required by the WCU IRB. This policy applies to investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials. For new NIH-funded clinical trials, you must provide documentation of training completion as part of the just-in-time process. It is not yet clear how NIH will implement this requirement for ongoing awards.