Abstract
Along with continued efforts to improve data
quality in clinical trials, it is imperative to make critical
assessments about the recognition, traceability,
and validation of the data on final outputs of
clinical trials. The present study investigated protocols
in 36 clinical trials and case report forms
(CRFs) for 141 patients. CRFs were categorized as
Book Type (BT), Visit Type (VT), and Separate
binding Type (ST). The achievement of recognition,
traceability, and validation of the data in CRFs
was assessed using arbitrary grading scales.
There were significant differences between the VT
and BT conditions in terms of traceability and validation
1 (the integrity of clinical laboratory test
data). No significant differences were observed
among the three types of CRFs in terms of recognition
and validation 2 (verification of test drug
compliance). These findings indicate that the
traceability and the integrity of clinical laboratory
test data depend on the structure of the CRFs used,
whereas recognition and verification of test drug
compliance were more matters of protocol
design. Therefore, of the three CRFs, the VT CRF is
considered to be the best choice of format for collecting
clinical trial data as it maximizes the quality
of clinical trials until electronic document systems
are adopted.
