UC San Diego Health Sciences (UCSDHS) Office of Compliance and Privacy provides regulatory guidance to the UC San Diego research community and promotes the responsible conduct of clinical trials and research through training and education, the development of written policies and procedures, monitoring and responding to reports of non-compliance. It is our goal to assist and support the UCSD research community in conducting efficient, compliant, and ethical research while building a culture of respect and accountability.
Audits and Monitoring
Clinical trials and research are subject to review or audit by internal or external authorities. Below are the types of reviews and audits conducted by the UCSDHS Office of Compliance and Privacy.
The purpose of the review is for quality assurance and to confirm the study is being conducted in accordance with the general concepts of Good Clinical Practices (GCP), the IRB approved research protocol and study documents, institutional policies, and all applicable state and federal laws and regulations.
If you receive an email notification of a Compliance regulatory review, there is no need to prepare. The main purpose of the review is to assist the research unit in identifying opportunities for process improvement, provide targeted training and education, and to identify trends in the conduct of research conducted at UCSD.
If you would like to request a regulatory review of your research study, please contact Compliance via email and include the study IRB number, reason for review, and contact information.
Compliance is responsible for conducting for-cause reviews or investigations related to research compliance concerns. These include concerns escalated by the UCSD IRB, internal or external committees, or University leadership. A for-cause review is an in-depth examination of all components of a research study and may include observations of processes, interviews with research staff, as well as a review of the research study documentation and research data.
For-cause reviews do not include concerns discovered through regulatory research reviews conducted randomly or requested by a research unit.
In order to comply with University policies, state and federal laws and regulations, any human subject research study in which clinical services are provided must adhere to UCSD Medical Center Policy (MCP) 342.2, Clinical Research Billing.
Compliance conducts random and for-cause billing audits in order to provide quality assurance, quality improvement, and education pursuant to research financial compliance and clinical research billing. Clinical research billing audits are initiated based on risk level, high enrollment, mixed billing, extensive services, case rates, etc.
Additionally, a for-cause audit will be initiated if significant issues of non-compliance are identified during the auditing process or the study has been escalated due to concerns raised by internal or external committees, the UCSD IRB, or University leadership.
Please contact Compliance Advisory Services for your questions about the Audit and Monitoring processes.
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