フォーラム
治験業務におけるカット・ドゥ・スクエア導入とそのアウトカム評価
キーワード:
Clinical Trial Document Support System,
registration trial,
efficiency,
documents,
information technology
2020 年 51 巻 2 号 p. 77-81
詳細
2020 年 51 巻 2 号 p. 77-81
In September 2018, we introduced the Clinical Trial Document Support System (developed by the Center for Clinical Trials, Japan Medical Association) for document management of registration trials. Here we report the practical issues that we encountered in the introduction process and the evaluation of outcomes from the viewpoint of efficiency. However, the system was not intended for use in investigator-initiated clinical trials.
The practical issues encountered in the introduction process were examined. The outcomes of introduction of the system were evaluated by the following parameters: registration document width (to reduce space for document storage), number of site visits by monitors to confirm documents (to reduce correspondence time), cost of printing and disposal of documents for institutional review board members (to reduce cost for the trial site), and number of letters exchanged between the trial site and the sponsors (to reduce costs for the trial site and the sponsors).
Introduction of the system resulted in the reduction of average document width from 37.2 cm to 0.8 cm, number of site visits by monitors from 14 to 11, average cost for trial site from 34,970 yen to almost none, and average cost for both trial site and sponsors from 199,446 yen to 88,531 yen.
The analysis revealed that introduction of the Clinical Trial Document Support System contributed to increase the efficiency of management of registration trials. Further analysis is required to evaluate short- and long-term contributions of introduction of the system in various settings.
