Best Practices

We leverage the best practices advocated in the field with a focus on research integrity to maximize the likelihood of successful projects.  Our standard practices include:

Maintain data privacy and security through all data handling steps, ensuring full HIPAA compliance.

Design CRFs that collect all data necessary to evaluate primary and secondary aims, are easy to use, and that minimize room for error.

Structure data collected to optimize quality control and to make it amenable to the data analysis plan and planned reporting.

Validate data according to standard documented procedures informed by intended analyses using range, type, consistency, and missing checks.

Create data capture systems suited to the specifics of the study that are easy to use, are constrained to maximize accuracy, with inherent data checks.

Design entry systems, databases, and study change procedures that maintain an audit trail in accordance with 21 CFR part 11.  Maintain a copy of the data state for each major analysis.

Regularly query the data for protocol compliance and safety reporting.

Integrate data from all project sources to assure complete data and package it into a form coherent to users.

Document all data handling procedures and study changes.

Communicate data structure and procedures to the project team.

Department of Biostatistics | 410 W. Tenth St., Suite 3000 | Indianapolis, IN 46202 | Ph: (317) 274-2661 | Fax: (317) 274-2678