Participation in a research project is one method of fulfilling the resident requirement to participate in scholarly activity according to the Accreditation Council for Graduate Medical Education. The Biostatistics Core provides statistical support to a fixed number of resident-driven research project slots per academic year.
Each department is allocated a number of projects to be supported proportional to the number of residents in the department. The department’s residency program director will evaluate the Research Proposal Form and select projects with a named faculty principal investigator to receive biostatistics support.
- The principal investigator assumes full responsibility for study activities, and for the integrity of the research data and results. As such, the PI is required to attend the initial consultation and strongly encouraged to attend all follow-up meetings. Residents will need to reschedule the initial consultation if the PI is unable to attend.
- The statistician should be a part of the study planning and IRB submission processes to help ensure appropriate sample size planning for both prospective and retrospective studies.
- The statistician will access study data on Loyola’s secure REDCap server. If residents do not use REDCap to store data, they must provide a clean data file with accompanying data dictionary on the shared research network drive. Importantly, before the statistician may receive study data, he/she must be a named research team member on the project application to the Institutional Review Board.
- Statisticians begin analysis services after all data collection activities are completed. If an interim analysis is pre-planned, those services will be provided as outlined in the protocol. The Biostatistics Core requests at least 30 days for a thorough analysis of study data.
- Project slots must be allocated within the academic year.
- Projects that fund a Biostatistician’s salary are exempt from this policy and are prioritized with separate Biostatistics resources.
- Projects not receiving biostatistics support through this mechanism may receive statistical support if departmental funding is available, however provision of services is contingent on CRO staffing levels.
- Projects should not exceed 40 hours of statistical support. Biostatisticians will monitor effort per project and will alert the study team at 30 hours completed. Approval for extended project support or for deviations from the scope of work must be approved by Drs. Colleen Fitzgerald and Greg Ozark.