Quality Assurance is a critical reflective process to consistently examine and evaluate human research activities at DU and its affiliates. This includes a corrective and preventive action process designed and executed in response to observed trends from audit results.
Quality Improvement is the process of enhancing human research performance based on the evaluation and interpretation of the metrics gathered during audits. Both qualitative and quantitative results are applied.
QA/QI is realized through the following services:
Random routine review of IRB approved research protocols, regulatory files, subject charts/ source documentation, research teams, IRB minutes. The Principal investigator my request a review in response to a subject complaint, staff concerns or for self-review to assure team remains in compliance.
Directed, for Cause Reviews
Requested by IRB chair or designee or institutional official related to safety or compliance concern or allegation.
Other Research Support Services
New Research Staff
An introduction of the institutional policies relative to the staff roles in their department. This complements the Clinical Research Group’s new staff Orientation.
Study Start Up Consultation
Support and guidance provided to complete the IRB submission process. Support provided to create the regulatory file/binder specific to the research protocol after IRB approval.
Education Training Sessions
Training or refresher session provided for research team on a requested topic.
External Audit Preparation Assistance
A full review of research related paperwork and processes performed prior to external audit. Support provided to address identified issues and prepare the research team for the external auditor interviews and review process.
Research Coordinator/Assistant Support
This support is designed for the staff assuming a new protocol, changing departments, involved with a complex protocol, or overall concern with the current process of the protocol The focus is to assure coordinator or assistant is using research tools to maintain compliance and process flow is efficiency
A support service requested unique to the researcher or protocol The QA/QIP representative will contact researcher and/ or provide assistance in locating appropriate support.