Construction of electronic data capture and its facilitating systems for a large scale clinical trial model
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概要
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Progression of investigator-initiated clinical trials has been hampered by the lack of efficient and costless infrastructure for driving the trials, with a paucity of definitive clinical evidence derived from our country. In order to construct such infrastructure without spoiling pertinent quality, this study prepared electronic data capture and its facilitating systems for a large-scale clinical trial model : multi-center randomized controlled trial for the secondary prevention of stroke, which is called J-STARS. Particularly, we have developed 1) web-based patient registration and data collection system, 2) automatic mail delivery system notifying follow-up data submission, and 3) PDF-based severe adverse events reporting system. Also, we have determined laborsaving data management procedure for the trial, in which bad data are extracted from the database and inquiry mails are semi-automatically sent out. By the preparation of these systems and procedure, infrastructure for conducting investigator-initiated large-scale clinical trials appears to be constructed. The infrastructure can be applied to the trials in other medical fields, potentially allowing for a promotion of such trials in our country.
- 一般社団法人 日本脳卒中学会の論文
一般社団法人 日本脳卒中学会 | 論文
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