The Protocol Development Team (PDT) specializes in developing and implementing investigator-initiated clinical trials. We provide research support to clinical and research faculty to expand the investigator-initiated clinical research platform within the UVA Cancer Center. PDT members collaborate with clinicians, research scientists, biostatisticians, clinical research coordinators, SOM-CTO and other core staff members to support the development clinical research, and offers assistance to Cancer Center members with:
- Drafting and editing of clinical trial protocols and trial related documentation (e.g. consent forms)
- Drafting and editing of LOIs and clinical trial associated grant submissions
- Development of study budgets
- Preparation and submission of protocol materials to internal review committees (e.g. PRC, IRB-HSR)
- Preparation of FDA submissions (e.g. IND and IDE applications, annual reports)
- Preparation and maintenance of regulatory files
- Project management
- Education of study staff
It's best to contact the PDT group early in the development process. PDT services are provided for a fee, but in certain circumstances the fee may be subsidized by the Cancer Center.
To discuss your investigator-initiated trial needs, please contact the Director, at:
The Office of Clinical Research provides support for all regulatory submissions of 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 including:
- Protocol submission to the PRC and IRB of record, including UVA IRB-HSR or central IRB.
- Maintenance of amendments and other regulatory aspects of study until close out.
- Education and communication for all required regulatory documentation.
The NCI administrator in the OCR also assists with:
- 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 Associate Director, Regulatory Affairs at: