Clinical Data Management
One of the main missions of the CRC is to assist clinical researchers in managing data from their clinical studies in accordance with regulatory requirements (Swissmedic, EMEA, FDA) and Good Clinical Practice (ICH). Management encompasses several aspects:
Developing an eCRF (collecting study-related data for each patient) via an electronic systemImproving data quality by implementing validity controlsManaging patient data and visit schedulesStoring, securing and anonymising these dataSupervising sites and the roles and permissions given to study staffCleaning up, exporting and processing (post-processing) study dataFinal data storage
We use the tool secuTrial© to assist with our data management. secuTrial© is a proven management system that has become the recommended choice for almost all Swiss Clinical Research Centres (Clinical Trial Units), as well as the Swiss Group for Clinical Cancer Research (SAKK), with the support of the SCTO (Swiss Clinical Trial Organisation).
We have also included the tool REDCapTM (see external link). This alternative data management system offers simple solutions for complex studies: secuTrial© or REDCapTM Which Database Should I Use for My Clinical Study? (CRC Symposium - June 2016)