Clinical Research Administration
Where do I get started?
Trying to start-up a new clinical study?
The SOM Submission & Planning Process is required for all clinical research, regardless of funding source, conducted within the School of Medicine.
Looking for guidance in a particular area?
SOM has issued guidance and required procedures in the following areas:
- Feasibility Assessment
- Coverage Analysis and Billing Compliance
- Budget Development and Negotiation
- Study Amendment Review Process
For a complete list of SOM Guidance and Process documents related to Clinical Research Administration click here.
Visit the Office of Research and Innovation’s Clinical Research Compliance Program website for university level guidance and requirements.
Are you a sponsor-investigator? Click here for university policy and procedure related to Faculty-Held IND/IDEs.
Need additional resources or support? Contact SOMCT@vcu.edu for questions or for assistance.
The SOM Clinical Research Team is available for team training, coordinator on-boarding, and study specific consultation. For a complete list of SOM Research Administration personnel, visit our contacts page.
The School of Medicine Clinical Research Team (SOMCT) is responsible for providing administrative oversight and support for all SOM clinical research studies.
The office manages the School's pre-study and study implementation processes for both externally-sponsored and internally-supported studies, and is responsible for establishing and maintaining school-level guidance and operating procedures to ensure compliant and efficient administrative and financial management of clinical research.
Current Items of Interest:
VCU Office of Research and Innovation Final Compliance Notices (requires VCU login)
CITI Good Clinical Practice (GCP) training is required for all study personnel on IRB Roster. (Requires VCU login)
The Office of Research and Innovation provides resources for the use of controlled substances in research. Refer to this website if planning to conduct a study that utilizes a controlled substance.
Visit the SOM Research Administration Training website to find past presentations on clinical research administration in the School of Medicine. To find out about upcoming SOM Clinical Research Administration meetings and trainings, go to training.vcu.edu, choose the sponsor, “Medicine,” and click “Search.”
Links to federal clinical research resources and guidance
- FDA - Clinical Research Versus Medical Treatment
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
- FDA IND Forms and Instructions
- CMS.gov - National Coverage Determination for Routine Costs in Clinical Trials