Quality Assurance provides support for investigators, sponsors, and study teams.
The Quality Assurance Program is charged with ensuring the compliance of clinical research conducted or reviewed by KUMC and its Institutional Review Board. The QA program offers a wide variety of services to the KUMC research community including collaborative reviews of clinical trials, education and training, and external audit preparation.
Internal Reviews and External Audit Preparation
The QA Program conducts routine reviews of clinical research conducted or reviewed by KUMC and its IRB. The QA staff work closely with investigators and study teams providing information regarding the review and educational/training opportunities for the investigator and study team. Additionally, the QA Program can assist in preparing for an audit conducted by an external agency or company as requested by the Principal Investigator.
FDA Inspection Preparation
The QA Program supports investigators notified that they, or one of their protocols, are the subject of an FDA inspection. QA staff will work with the investigator and their study team to assist in preparing for the inspection and host/co-host the inspection.