Navigate

• 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
• FDA faculty-held IND-IDE program and consultation
• 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
• Human Research Protection Program
• Clinicaltrials.gov program
• Coverage analysis guidance

VCU Health System policies

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 coordinator training
• Good clinical practice training
• Advanced clinical research coordinator course

• 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)
  • VCU clinical research/trial quality system
  • Final standard fees document (requires VCU eID credentials)
• Federal regulations
  • ClinicalTrials.gov requirements
  • Federal policy for the protection of human subjects
  • FDA guidance
  • ICH good clinical practice guidelines
  • Medicare coverage related to IDE studies
  • NIH clinical trial requirements for grants and contracts