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.
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.
