Study Design Consultation

Consultations occur at the initial stage of study planning, preferably before IRB submission. Design issues vary by study type (clinical trial, community-based participatory research, or population-based study).

In general, these issues pertain to the development and conduct of the study and could include possible participants, selection criteria, intervention assignment and implementation, endpoint determination, a data analysis plan, and sample size considerations and calculations.

Database Management

After finalizing the study design, CCTS researchers are encouraged to develop templates for database design. The level of complexity involved in creating a database depends upon the complexity of the study.

Consultations generally include discussions on types of variables to be collected, methods of data entry, and database security. Data management support is also available during data collection (data audits) and at the end of study (database lock).

Data Analysis

Depending upon the CCTS researcher's needs, during the design consultation BDRE will develop an analysis plan that is specific to the needs of the study. The analysis plan may include quantitative, qualitative, or a combination of both types of analyses. Research assistants, supervised by a BDRE faculty member, will be available to assist in the implementation of the analysis plan.

Research Ethics

In the event that the study proposed by the CCTS researcher involves a question of research ethics, a biomedical ethicist will be available for consultation (aka "benchside ethics consultation").