Protocol Development Team
The Protocol Development Team (PDT) provides
expertise in developing and implementing investigator-initiated clinical trials. The team provides 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 clinical research. We offer assistance to Cancer Center members with the following:
- Drafting and editing of clinical trial protocols and trial related documents (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., Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications, annual reports)
- Preparation and maintenance of regulatory files
- Project management
- Education of study staff
It’s best to contact the PDT early in the development of your study concept. Investigators are asked to enter their protocol concept and requests for assistance through a RedCap-based platform.
Requests for biostatistical support for investigator-initiated clinical trials should be made through the Biostatistics Shared Resource.
To begin the process for requesting assistance through RedCap, view a summary of the workflow, and see the cost-structure model for investigator-initiated trials, follow these directions.
Costs
PDT services are provided for a fee, but there may be an opportunity to have a portion of the services subsidized by the Cancer Center. For additional information, please refer to the information for Investigator-Initiated Trial (IIT) Support.