Orthopaedic Surgery's Research Program Management Office

• Cancer Center Protocol Review Committee (PRC) Review: All cancer-related studies are required to be reviewed by the UCSF Helen Diller Comprehensive Cancer Center Protocol Review Committee. Studies must first be reviewed by a Cancer Center Site Committee before being submitted to the PRC through OnCore. The CHR will not give initial approval for any cancer-related study until the PRC has granted full approval or exemption. Review the PRC website for more information.
• CHR Application: The CHR application is completed and submitted online through iRIS accessible through MyAccess.

As of January 2, 2013, all UCSF human studies are required to perform a feasibility analysis and undergo scientific review prior to submission of the CHR application. The feasibility analysis requires completion of a checklist by the study staff and principal investigator. Scientific reviews are performed by either the UCSF scientific review committee or the school/departmental peer review committee. Download the appropriate forms and review the details on the Clinical Research Resource HUB.

Research studies involving radiation exposure to human subjects, whether as part of a standard or care or for research purposes only, must submit a form for review the RSC/CHR coordinator. The RSC/CHR coordinator will assist in completing a Radiation Use Authorization (RUA) to be reviewed by the full Radiation Safety Committee, if required.

APeX is UCSF’s electronic medical record system. Information for clinical research coordinators and investigators on training, access and how to create and maintain the research study account can be found online through the APeX Knowledge Bank. An APeX study account must be created for studies involving medical center procedures using medical center equipment.

• HIPAA Training:  All individuals working at UCSF are required to complete HIPAA training upon hire.
• Human Subjects Training:  All UCSF key personnel conducting human research must complete human subjects protection training through an online program called the Collaborative Institutional Training Initiative (CITI). Review the CHR’s website for more information. Training is required to be renewed every three years.

• Clinical Research Resource HUB
• Committee on Human Research (CHR)
• Enviromental Health and Safety (EH&S)