发明名称 Method and system for verification of source data in pharmaceutical studies and other applications
摘要 A method and system are described for verifying database entries against corresponding source data collected at a plurality of geographically remote field locations. The invention provides for verification of field data in a manner that is quicker, less labor-intensive and less error-prone as compared with existing methods. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.
申请公布号 US9418098(B2) 申请公布日期 2016.08.16
申请号 US201514604586 申请日期 2015.01.23
申请人 Paladin Alicia W 发明人 Rosenberg Michael Joseph
分类号 G06F7/00;G06F17/30;G06F19/00 主分类号 G06F7/00
代理机构 代理人 Goldstein Ronald B.
主权项 1. A computerized method for verifying the accuracy of data previously stored as a value in a centralized database in a clinical trial or other process being conducted at a plurality of remote sites, so as to determine whether said database value correctly reflects corresponding source data originally collected at a remote site, and whether said database value accordingly should be maintained or else corrected, said method comprising the steps of: (a) accessing a centralized database containing values representing the current product of data previously collected and/or recorded in the field; (b) ascertaining, with respect to each remote site, the number of values in said database that are to be verified for accuracy; (c) comparing the number of values ascertained in step (b) for the respective remote sites, so as to rank the respective sites according to said numbers; (d) determining the priority of each remote site with respect to verifying the accuracy of values in said database, based on the comparing in step (c), wherein said priority is greater for a site for which a higher number was ascertained in step (b) than for a site for which a lower number was ascertained in step (b); (e) according to the priority determined in step (d), comparing a value in the database with the corresponding, originally collected source data; (f) determining whether the database value agrees with said source data; (g) if it is determined according to step (f) that the database value agrees with said source data, creating a record that said database value has been verified; and (h) if it is determined according to step (f) that the database value does not agree with said source data, generating a query with respect to said database value.
地址 Chapel Hill NC US