Research Study Life Cycle Support
Contact UsWhat We Do
Study Design and Development
We collaborate with lead investigators to design research studies that efficiently address scientific hypotheses, typically in a multicenter context. NUDACC faculty have experience designing a wide range of both observational studies and clinical trials. Learn more about study designs in our existing collaborations here.
Grant Writing
NUDACC is committed to grant development with multidisciplinary investigators through a range of NIH R, U and P mechanisms. NUDACC faculty serve as PIs of independent data analysis and coordinating center applications, or as MPIs or Co-Is on single funding submissions. The optimal arrangement depends on the nature of the study and the funding mechanism. At this time, NUDACC does not charge for grant writing and development.
Data Coordinating and Analysis
NUDACC is committed to providing rigorous and efficient research study infrastructure including data collection tool development, database development and maintenance, ongoing data quality assurance and curation, regulatory reporting and statistical analyses of accumulated data. NUDACC provides this expertise as part of research teams funded through grants or other mechanisms.
Development of Procedures
We develop rigorous, flexible, unique solutions to ensure efficient and compliant research operations. In particular, NUDACC faculty and staff have experience writing protocols, developing manuals of procedures, leading the single Institutional Review Board submission process, developing recruitment materials, coordinating study committees and meetings, and performing on-site and remote monitoring.
Partnerships
NUDACC faculty hold academic appointments in NU FSM’s Department of Preventive Medicine, Division of Biostatistics. NUDACC faculty collaborate closely with, and in some cases are contributors to, NUCATS’ Biostatistics Collaboration Center and the Lurie Cancer Center Quantitative Data Sciences Core.
Study Life Cycle Components
Exemplar Activities
- Prospective clinical or observational research study design
- Sample size and power calculations
- Grant writing
- Randomization procedure development
- Recruitment and feasibility studies
Exemplar Activities
- Data collection tool development, e.g. case report forms (CRFs)
- Database construction and maintenance
- Programming of automated range, logic and consistency checks
- Data query management and resolution
- De-identification and data security
- Regulatory and ethics committee reporting including Data and Safety Monitoring Board (DSMB) reporting
Exemplar Activities
- Manual of Procedures for study conduct, specimen collection, pharmacy activities, and general operations
- Data Management Plans
- Data and Safety Monitoring Plans
- Recruitment materials, social media ads, brochures, websites
- Study governance development
- Coordination job tools such as guidance documents, logs, and paper CRFs
- sIRB submissions
- FDA submission assistance
- Study meeting support for large in-person conferences and smaller ongoing committees
- Study supply ordering and distribution
Exemplar Activities
- Statistical analysis plan development
- Interim statistical analyses
- Final statistical analyses
- Manuscript development and dissemination of findings
- Ancillary study development
- Methodologic innovation