Services
BPSSR offers comprehensive services as follows to support protocol development, grant application, abstract and manuscript preparations, and other collaborations.
- Design of clinical trials: Participate in developing all aspects of clinical protocols, from letter of intent (LOI) through full protocol creation for investigator-initiated trials (IITs).
- Design of observational studies: Develop study design (e.g., cross-sectional, longitudinal, case-control) and analysis plans for prospective or retrospective studies.
- Design of preclinical & translational studies: Develop sample size and analysis plans.
- Design of patient-reported health outcome (PRO) protocol and measurement: Select optimal survey instruments and design questionnaires.
- Design randomization schemes, perform case report form (CRF) reviews, conduct interim analysis, and generate monitoring reports.
- Statistical data analysis: Analyze data using standard and cutting-edge methods for preclinical and translational studies, clinical trials at all stages, and observational studies.
- Large-scale population health analysis: Analyze administrative healthcare claims, cancer registry, Electronic Health Records (EHR), national survey, and U.S. census data, using epidemiologic analysis, econometrics analysis, geospatial analysis, and data visualization and mapping.
- Support procurement of restricted-use datasets from multiple sources (e.g., EPIC data, UVA Cancer Registry, SEER-Medicare).
- Assist with data procurement related IRB application and data application process and Data Use Agreement (DUA).
- Develop and manage Research Electronic Data Capture (REDCap) databases, including data capture, documentation, quality review, storage, and backup.
- REDCap database review (only conducted if BPSSR will be collaborating on data analysis).
- Implement effective data sharing and create shareable dataset to comply with NIH data sharing requirements.
- Review protocols for scientific validity as members in the UVACCC Protocol Review Committee (PRC).
- Choose cases for audit by the University’s Post Approval Monitoring process.
- Serve on the UVACCC Data & Safety Monitoring Committee (DSMC).
- Support for qualitative studies: Conduct interviews and focus groups.
- Facilitate pre-NIH submission proposal reviews (external and/or internal).
- Teaching: Offer formal and informal courses, lectures, and seminars to Cancer Center members and trainees. Topics cover clinical trial design and analysis, preclinical and observational studies, and cancer epidemiology.