The system is designed based on foreign guidelines on CDM (clinical data management) such as GCDMP(Good clinical trial management practice) issued by Society for Clinical Data Management in the US, Writing Code Of Data Management Plan issued by European Clinical Research Data Management Association as well as regulations on GCP by ICH, WHO and China. It adopts state-of-the art data acquisition method-internet-based electronic data acquisition to construct multiple clinical research centers to conduct data management work in clinical research.
Functions and Features
Support various means of data acquisition, including manual data entry, direct capturing data from HIS, LIS, PACS and other systems, entry on mobile devices so as to satisfy capturing needs in different circumstances.
During the process of data entry, the system check the accuracy of all the data through comparison with normal value and effective value in addition to other means.
The system provides internet-based instant messaging function for timely exchange of messages between participants of the drug clinical trial and thus better data management.
The system provides the powerful statistic search engine that is able to meet varied statistic and search requirements by allowing users to custom combination of search conditions. It is also enable to display diversified search information for users to view search results more readily.
The system has a perfect and secure ID authentication mechanism, ensuring the security of data and project documents. It adopts technologies of online data backup, online system update and online parameter maintenance, supporting a 7×24 non-stop operation.
The system provides interfaces to specialized medical statistic software so that trial data can be directly exported to specialized medical statistic software for data analysis. Currently, the software supported by the interface are SAA and SPSS.
The system provides SDV, manual check and logic verification as three genres of data verification. SDV targets electronic data that are inconsistent with paper data; manual check is conducted by the inspector on all electronic data; logic check is carried out automatically after relevant items to be checked are maintained into the system.