In order to standardize data management related to the lifecycle of drugs, the Center for Food and Drug Inspection held an expert seminar on June 15, 2016. Participants included representatives from relevant departments of CFDA and institutions directly affiliated to CFDA, universities and industry associations, and experts from the US FDA's China Office and WHO China Representative Office as well as members of the drafting committee for Drug Data Management Practices.
The seminar discussed the framework of the first draft for Drug Data Management Practices and the Chinese translations for certain English terminologies. The participants had a heated discussion and exchange of opinions on the term DI (Data Integrity). The word "integrity" means honesty and uprightness, and the direct translation of "completeness" (完整性) is inappropriate and loses some of the original meaning of the term. The experts therefore agreed that “data integrity” should be more appropriately translated into "data reliability" (数据可靠性).