Protocol & Regulatory Development

The Office for Clinical Research is committed to supporting Cancer Center clinical investigators in the development and implementation of investigator-initiated clinical trials. The OCR assists investigators at any stage in their trials by offering specialized assistance in the following:

  • Development and writing of clinical trial protocols in compliance with regulatory authorities
  • Assistance with submissions to PRC and IRB-HSR
  • Preparation of additional documentation (i.e. FDA submissions, Informed Consents and Investigators Brochures)
  • Educate study staff to assist study start-up
  • Individualized support 

To discuss your investigator-initiated trial needs, please contact our Protocol Development Specialist,

Additional Resources:

Regulatory Coordination

The Office of Clinical Research provides support for all regulatory submissions of investigator-initiated cancer clinical trials for scientific and ethical review.   All oncology groups are offered specialized assistance including:

  • Assistance with protocol submission to the PRC and IRB-HSR
  • FDA regulatory documentation preparation and submission
  • Education and communication for all required regulatory documentation

The Regulatory Specialist in the OCR also assists with NCI administration.  These regulatory services consist of:

  • CITI training tracking for all new and current UVA NCTN members
  • Submission of regulatory packets to NCI for renewal and new physicians

To discuss your regulatory needs, please contact the Regulatory Specialist at:

Regulatory Specialist
Tel: 434.243.7064 
Fax: 434.982.3509