Available Services

Available Services

The Clinical Trials Office provides assistance with many of the services required to conduct a human subject research trial. These resources are in place to make the entire process run more efficiently.

 

Pre-Study Assistance

  • IND/IDE submission
  • Regulatory document preparation
  • Protocol development
  • Case Report Form (CRF)/source document development
  • Budget preparation and negotiation
  • Grant Billing Process
  • Site Evaluation
  • Advertisement development and preparation
  • Contract Submission

Mentoring

  • The Mentoring program is a comprehensive training program that is tailored to the needs of the individual CRC.
  • The goal is to equip the CRC with the relevant knowledge and skills that he/she will need in order to conduct compliant and efficient research studies.

Continuing Education (Coordinators)

  • Working with the Center for Organizational Development, the CTO offers training and education focusing on the various aspects of clinical trials. This education is designed to keep CRCs and PIs abreast of current trends in the conduct of clinical trials.
  • Annual continuing education series
  • Brown Bag sessions
  • External audio conferences
  • Tips of the Month
  • Online orientation manual

Budget and Billing Training and Assistance

  • The Clinical Trials Office can assist you in developing study billing coverage analyses, setting up grant registration, reconciling of patient account statements, and will perform billing reviews.
  • They are also available to set up a brief billing training.

Monitoring

The Clinical Trials Office offers monitoring services as well as training for new monitors working with UVA investigators who have assumed the role of Sponsor for a clinical trial.

Quality Assurance

  • Maintenance of Standard Operating Procedures for the conduct of clinical trials in the School of Medicine
  • Training and orientation of the clinical trial process for clinical research personnel
  • Assisting in preparation for FDA, sponsor, or internal audits

FDA Inspection Assistance

Contact the SOM Clinical Trials Office if you are notified by the FDA of a site inspection/audit.

The SOM Clinical Trials Office is experienced in facilitation of, and participation in, FDA inspections. The SOM CTO can provide inspection readiness training, and can serve as inspection facilitator, if requested by the investigator. The SOM CTO is available during any FDA inspection to provide consultation services as the inspection proceeds.  Someone from the SOM CTO should be present at the “exit interview” at the conclusion of the FDA inspection.  Finally, the SOM CTO can provide assistance in responding to any inspection observations.

Clinical Trial Opportunities

The Clinical Trials Office acts as a resource for industry sponsors recruiting or clinical trial sites.

For more information on how we can assist you, please call (434) 924-8530 or e-mail us at uvaclinicaltrials@virginia.edu.