Regulatory Coordination

The Office of Clinical Research provides support for all regulatory submissions of both industry and NCI-sponsored cooperative group cancer clinical trials for scientific and ethical review. All oncology groups are offered specialized assistance.

The team is divided into two groups, supporting required tasks for both: 

  • Pre-award activation
  • Post-award regulation

Activation (Pre-award) Support

This team is responsible for:

  • CDA routing
  • Pre-selection site visits (PSV),
  • Regulatory submission to the PRC, IRB of record, including UVA IRB-HSR or central IRB and other internal committees
  • Essential sponsor document submission and study activation until Site Initiation Visit (SIV)

For more activation information, email or call 434.243.7064 to talk to Kirsten Bugden, Activation Manager. 

Regulatory (Post-award) Support

This team is responsible for:

  • Maintenance of amendments and other regulatory aspects of study from SIV until close out
  • Archiving of study materials post close-out
  • Education and communication for all required regulatory documentation
  • CITI training tracking for all new and current UVA NCTN members
  • RCR Submission to NCI for new physicians and renewals for existing physicians

For more regulatory information, email or call 434.243.8588 to reach Stacey Williams, Regulatory Manager.