C. KENNETH AND DIANNE WRIGHT CENTER
FOR CLINICAL AND TRANSLATIONAL RESEARCH

VCU / VCU Health Clinical Research Standard Operating Procedures (SOPs)

The Clinical Research Standard Operating Procedures (SOPs) 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.

VCU Employee and Facility Use Guidelines for Clinical Research  (VCU eID required)

The VCU Employee and Facility Use Guidelines for Clinical Research document is for VCU employees who engage in clinical research within VCU facilities. Further, these guidelines identify requirements for VCU facilities/space where VCU employees may directly engage with clinical research participants. These guidelines do not impact VCU Health System employees or VCU Health System Facilities. The purpose of these published guidelines (including requirements and recommendations) is to support principal investigators, who must ensure that:

1. VCU employees with direct interactions with research participants are prepared with adequate training and experience for their job responsibilities and
2. VCU facilities/space utilized for direct contact with research participants (for study-related activities) meet existing requirements for environmental health and safety.

Joint Task Force (JTF) for Clinical Trial Competency

The JTF for Clinical Trial Competency developed the Core Competency Framework for clinical research professionals.  It was intended to align clinical researchers worldwide around a single, comprehensive set of competencies for the profession. The Framework is comprised of eight (8) domains:  1. Scientific Concepts and Research Design, 2. Ethical and Participant Safety Considerations, 3. Investigational Products Development and Regulation, 4. Clinical Study Operations (Good Clinical Practice), 5. Study and Site Management, 6. Data Management and Informatics, 7. Leadership and Professionalism, 8. Communications and Teamwork.

Central VA SOCRA Chapter Meeting Space: past meeting recordings and materials 

The Central Virginia SOCRA Chapter is sponsored through the C. Kenneth and Dianne Wright Center for Translational and Clinical Research.  Meetings are held regularly and available to all within the clinical research ecosystem whether SOCRA members or not.

Past meeting recordings and materials are available via the Canvas Catalog platform.  Enrollment in the SOCRA meeting “course” is a one-time requirement to view the recordings and materials. Following enrollment, access is through VCU Canvas login .

Follow the Central VA SOCRA Chapter on LinkedIn.

ReGARRD (Regulatory Guidance for Academic Research of Drugs and Devices)

ReGARRD provides academic researchers with the regulatory tools and resources necessary to successfully navigate the pathway from discovery to clinical implementation of new drugs, biologics, and medical devices.    Comprised of seven institutions from the Southeast US, ReGARRD enables sharing of ideas, lessons learned, historical information, and the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment. 

NIH: Office of Clinical Research:  Education and Outreach

HHS: Office of Research Integrity:  Interactive videos and case studies

FDA Regulatory Information:  Search for FDA guidance documents, learn about the laws enforced by FDA, and more.

International Council of Harmonization (ICH): ICH Guideline database