VCU/VCUHealth Clinical Research Standard Operating Procedures
Our Standard Operating Procedures (SOPs) for clinical research are an essential framework for VCU and VCU Health research teams. These SOPs establish consistent best practices, promoting quality, efficiency, and compliance throughout our clinical research enterprise. SOPs lay the groundwork for operational excellence, offering guidance for routine tasks. Each SOP is connected to additional resources and tools, including VCU IRB written policies and procedures and VCU Health policies. It is important to note that if you collaborate with another IRB, their policies and procedures will also apply.
These SOPs have been developed in alignment with Good Clinical Practice (GCP) and international quality standards, which are mandatory for all VCU clinical trials. They are also relevant to all clinical research and trials involving VCU Health clinical services and facilities. These SOPs are recognized as the benchmark for best practices and can serve as a valuable guide for clinical research within VCU.
While our core SOPs define the common standards in accordance with regulations and policies, individual schools or centers may develop their own SOPs and working guidelines to specify further how procedures should be conducted. In both instances, these documents must meet or exceed the standards outlined in this core set of SOPs.
Please note that these are the most up-to-date SOPs. You can find the other that are under review here.
CR-ST-200: Clinical Trial Registration and Reporting
CR-ST-205 Investigator Conflicts of Interest
CR-ST-210: Agreements for Externally-Sponsored Clinical Research
CR-ST-215 Coverage Analysis
CR-ST-220 Form FDA 1572
CR-ST-225 Pre-Study Site Qualification Visit
CR-ST-230 General Research Staff Training and Clinical Permissions
CR-ST-235: Site Initiation Visit
CR-ST-240: Study-Specific Staff Education and Training
CR-RE-300 Adverse Event and Management and Problem Reporting
CR-RE-305: Coordination of External Regulatory Audits
CR-RE-310: Data Safety Monitoring
CR-RE-315: Informed Consent
CR-RE-325: IRB Submissions and Communications
CR-RE-330: Participant Research Complaints or Concerns
CR-RE-335: Protecting Confidential Information
CR-RE-340: Protocol Deviations and Violations
CR-RE-345: Radiation Safety Committee
CR-RE-350: Sponsor-Investigator (IND/IDE) Applications
CR-RE-355: Sponsor Monitor Visit
CR-RE-360: Study-Specific Communications
CR-IP-400.3: Investigational Drug Management and Transfer to Satellite Pharmacies
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