Regulatory Coordination
The Office of Clinical Research provides support for activation and regulatory submissions of industry sponsored, NCI cooperative group and non-UVA investigator-initiated cancer clinical trials.
UVA Investigator-Initiated cancer clinical trials are supported via the Protocol Development Team.
The OCR regulatory team is divided into two groups, supporting required tasks for both:
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 information, please contact Eleanor Gorham, Activation Manager, at eg3ap@uvahealth.org or 434-297-5726.
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 information, please contact Kirsten Bugden, Regulatory Manager, at kb8wj@uvahealth.org or 434-243-7064.