title: Fundamental data quality assessments of clinical trials in Japan.
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.
authors.affiliation: Department of Health Science Policies, Division of Research Development, Graduate School of Medicine and Dentistry, Tokyo Medical and Dental University, Japan. jimsai@k9.dion.ne.jp
authors.forename: Hajime
authors.initials: H
authors.lastname: Saijo
authors.forename: Hiroi
authors.initials: H
authors.lastname: Kasai
authors.forename: Hiromitu
authors.initials: H
authors.lastname: Takahashi
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Harigai
authors.forename: Kozo
authors.initials: K
authors.lastname: Takase
mesh_terms: D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic / Q000592:standards*; D004282:Documentation / Q000592:standards*; D006801:Humans; D007564:Japan; D010349:Patient Compliance; D011786:Quality Control; D011996:Records; D012107:Research Design / Q000592:standards; D035842:Research Subjects