Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database
Title
Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database
Abstract
Monitoring of clinical trials includes several
disciplines, stakeholders, and skill sets. The aim
of the present study was to identify database
changes and data entry errors to an electronic
data capture (EDC) clinical trial database,
and to assess the impact of the changes. To accomplish the aim, Target e*CRF was used as
the EDC tool for a multinational, dose-finding,
multicenter, double-blind, randomized, parallel,
placebo-controlled trial to investigate efficacy
and safety of a new treatment in men with
lower urinary tract symptoms associated with
benign prostatic hyperplasia. The main errors
observed were simple transcription errors from
the paper source documents to the EDC database. This observation was to be expected,
since every transaction has an inherent error
rate. What and how to monitor must be assessed
within the risk-based monitoring section
of the comprehensive data monitoring plan.
With the advent of direct data entry, and the
elimination of the requirement to transcribe
from a paper source record to an EDC system,
error rates should go down dramatically. In addition, protocol violations and data outside the
normal range can be identified at the time of
data entry and not days, weeks, and months after the fact.