1. Disorganized Paper Form
Simplifying Data Quality Assessment through Audit Software Stephany N. Duda, PhD; Firas H. Wehbe, MD, PhD; Catherine C. McGowan, MD Vanderbilt University, Nashville, TN, USA
BACKGROUND
Source document verification audits are the gold standard for assessing data quality in clinical research.1 During such audits, external auditors compare submitted research datasets to the original documentation of patient care, which may include paper clinical charts, laboratory reports, or the contents of electronic medical record and laboratory systems at the study sites.
assisted audit tool should possess in order to simplify and standardize the audit process. 4
IMPLEMENTATION
We developed a prototype system to demonstrate the significance of these key attributes as well as the feasibility of implementing them in a simple web-based application.
Most audits use paper forms, which can be difficult to standardize, share between auditors, and interpret post- audit. The available audit software packages focus on analyzing an existing, elec- tronic dataset for errors and unusual patterns, rather than facilitating the compar- ison between the dataset
Audit Tool Prototype
Disorganized Paper Form
Home Screen
Audit Data Entry Screen
and a physical source document. We believe a computer-assisted audit tool specifically designed for research data auditing can improve the process of source document verification.
Improved Audit Results Form
METHODS
The CCASAnet data center conducts on-location, Good Clinical Practice-based audits of datasets submitted by member sites.2,3 We reviewed the audit documentation and reports of auditor experi- ences collected during 14 paper-based data audits and subsequent communications with study sites.
We tested this application during audits of twelve cancer and tuberculosis datasets in nine locations and found the system drastically improved the audit process by
decreasing audit preparation time from over six hours, on average, to less than one hour,
enforcing consistent, on-site error coding for all audited data,
eliminating difficulties reading other auditors’ completed forms, and
simplifying the manual error tallying required for generating a post-audit report.
FINDINGS
We identified five key attributes that a computer-
Key Software Attributes
Multi-user support through networking
Simple file formats for importing and exporting research and audit data
Standard error assessment protocols
Audit decision support for record selection
Tools for calculating and displaying audit results
CONCLUSIONS
We believe audit software with these attributes has the potential to simplify the audit process for investigators wishing to implement an internal data quality program to ensure the validity of their research data and study findings.
1 Developing and implementing a comprehensive clinical QA audit program. Li H, Hawlk S, Hanna K, Klein G, Petteway S. The Quality Assurance Journal. 2007; 11: 128–137.
2 ICH Harmonized Tripartite Guideline: Guideline for Good Clinical Practice E ; Available from:
3 Measuring the Quality of Observational Study Data in an International HIV Research Network. Duda SN, Shepherd BE, Gadd CS, Masys DR, McGowan CC. PLoS One. In press.
4 Desiderata for a computer-assisted audit tool for clinical data source verification audits. Duda SN, Wehbe FH, Gadd CS. Stud Health Technol Inform. 2010;160(Pt 2):894-8.
Funding for this work was provided by US NIAID (NIH U01 AI069923)