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.