VCU/VCUHealth Clinical Research Standard Operating Procedures
Our clinical research SOPs provide a common framework for VCU and VCU Health teams, supporting quality, efficiency, and regulatory compliance across clinical research. They are aligned with Good Clinical Practice (GCP) and apply to all research using VCU Health services or facilities. Individual schools, centers, or departments may develop additional SOPs or working guidelines to describe local procedures in more detail, but these documents must meet or exceed the standards established in this core SOP set.
Users are expected to access SOPs directly from the official SOP website before distributing or applying them and should avoid retaining local copies to prevent use of outdated versions.
Last updated: March 19, 2026 – Please verify SOP version numbers using the Table of Contents before use.
For general inquiries about the Clinical Research SOPs, please contact:
- Rose Williams
- 1 (804) 828-8583
- crsop@vcu.edu
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-320: Institutional Biosafety Committee
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
CR-IP-410 : Investigational Device Management
CR-CO-500: Blinding – Codes and Code Breaking
CR-CO-505: Case Report Form Compliance
CR-CO-510: Clinical Research Record Management
CR-CO-515: Data Clarification
CR-CO-520: Data Management
CR-CO-525 : Delegation of Authority
CR-CO-530: Electronic Data Capture Systems
CR-CO-535: Enrollment on Ancillary Studies
CR-CO-540: Essential Documents Maintenance
CR-CO-545: Participant Status and Change of Status
CR-CO-550: Participant Visits and Assessments
CR-CO-555: Record Retention and Archiving
CR-CO-560: Screening and Recruiting Research Participants
CR-CO-565: Source Documentation
CR-CO-570: Human Biological Specimen Collection, Handling, and Shipping
CR-CO-575: Study Interim Data Analyses and Reports
CR-CO-580: Transfer of Participants Between Institutions
CR-CO-585: Use of Notes to File