Human research
VCU is committed to the integrity and quality of our research as an essential component of human research protections.
Study pipelines
Clinical research resources across the enterprise
- Biomedical Informatics request portal
- Cohort discovery: TriNetX, ACT and I2B2 (links may require login credentials); multisite studies: Trial Innovation Network
- Data management plan tool
- External Clinical Research Monitor Access (VCU Health)
- OnCore Clinical Trials Management System
- OVPRI RAMS Systems
- Recruitment tools: Study Finder and Research Match
- REDCap Electronic Data Capture
- Protect your intellectual property: For inventors
- Biostatistics, Epidemiology and Research Design
- Community engagement
- Mock study sections
- Protocol development resources
- Research data management
- Clinical units: Clinical Research Unit at VCU Health and Pediatric Clinical Research Office at Children’s Hospital of Richmond
- Recruitment planning and resources
- Research data management program (VCU Libraries)
- Research hubs: Massey Cancer Center Clinical Trials Office and School of Medicine Research Administration office
- Study conduct toolkit
- Clinicaltrials.gov program
- Researcher support available through the VCU Libraries
It is essential to review the VCU Health policies and procedures related to clinical research, which includes essential program information, including:
- procedures for scheduling research participants
- the VCU personnel clinical permissions registration process
- monitor access information and applicable policies and procedures to monitors of clinical trials
- resources and services available through the VCU Health Clinical Research Office to support clinical research operations and clinical trial participants.
- Clinical research standard operating procedures (VCU/VCU Health; requires VCU eID credentials)
- VCU notices and policies
- VCU compliance notices
- VCU employee and facility use guidelines for clinical research (requires VCU eID credentials)
- Federal regulations
Learn more about our services
The Human Research Protection Program applies to the institution and all entities relying upon the institution and includes program governance, quality assurance and reporting as well as the oversight over any local ethics board operations.
The big lens of institutional responsibilities sets the standards for quality and evaluates the changing environment
Institutional Review Boards provide the ethics reviews which the HRPP relies in accordance with federal, state and local/institutional standards. The HRPP has oversight of the local IRB (e.g., VCU Panel A) and oversees the use of external IRBs.
Focus on individual protocols and participant protections
Regulatory affairs is established via a partnership hub located in the OVPRI. The hub helps to connect expertise across the institution in the design of long-range regulatory strategies (e.g., long-range planning for institutional intellectual property, data security, rights and responsibilities, and submission to regulatory agencies for future clearances or approvals.
The strategy
Investigational Drug Services at VCU Health provide research-only pharmacy services to clinical studies that include investigational medications on the Medical College of Virginia (MCV) campus, as well as study dispensing oversight and guidance for VCU Health satellite pharmacy locations.
Provides access to investigational product
The C. Kenneth and Dianne Wright Center for Clinical and Translational Research leads the development of research training, standards, quality and opportunities for the communities we serve. The Wright Center fosters research collaborations across the state and accelerates the translation of scientific discoveries to patient care.
Outreach
Contact us
HRPP/IRB
Sandy L. Brooks, DPS
Director, human subjects protection
Phone: (804) 828-0131
brookss15@vcu.edu
Regulatory affairs
Lauren Wallace, MS, RAC-Drugs
Director of clinical research regulatory affairs
kanigherl@vcu.edu
Training
For training opportunities and resources, visit:
Forms
Visit our Forms page for documents related to human research.