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A quantifiable alternative to double data entry.

D W King¹, R Lashley

¹STATKING Consulting Inc., Fairfield, OH 45014, USA.

Controlled Clinical Trials

|March 15, 2000

Summary

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This study proposes a continuous sampling plan as an alternative to double data entry for improving clinical trial data quality. This method offers a cost-effective way to ensure data accuracy without full double entry.

Area of Science:

Clinical data management
Statistical quality control
Health informatics

Background:

Double data entry (DDE) is a common method for ensuring clinical trial data quality.
The effectiveness, cost, and data quality gains of DDE remain debated.
There is a need for efficient and quantifiable data verification methods.

Purpose of the Study:

To introduce and evaluate an alternative to the verification step in double data entry.
To present a sampling procedure for data verification that is cost-effective and quantifiable.
To demonstrate how to select parameters for this data quality assurance procedure.

Main Methods:

The proposed alternative involves verifying a sample of records from a single-entered dataset.
A continuous sampling plan (CSP) from statistical quality control literature is utilized.

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The method allows for computation of cost/time and data quality improvements.

Main Results:

The continuous sampling plan offers a quantifiable approach to data quality assurance.
This method is easily performed by data entry personnel.
The sampling plan can be tailored to meet specific data quality goals.

Conclusions:

A continuous sampling plan provides a viable and efficient alternative to double data entry for clinical trial data.
This approach allows for objective assessment of data quality and associated costs.
The method facilitates setting and achieving data quality targets in clinical research.