Protocol Development & Regulatory Coordination

Protocol Development

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:

Kim Bullock, PhD, CCRP
kb9d@virginia.edu
Tel: 434.924.0180

Regulatory Coordination

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:

Parchayi Dalal, MPH, CCRC 
pd9d@virginia.edu 
Tel: 434.924.5060