Clinical Data Management System
This is the most sophisticated module in CIMS. The CDMS encompasses a full range of clinical data management activities including easy eCRF design build, easy study setup, easy edit check creation, comprehensive query management, flexibly adding unscheduled forms, and efficient source document verification (SDV). CDMS can be turned on as a full EDC system and turned off for paper CRF trials with double-key entry feature.
- User Friendly Interfaces– The data entry interface has the same layout as the CRF or hospital chart. making it easy for site to enter data and easy for monitors to perform SDV.
- Status Bar – Displays multiple status (entered by CRC, reviewed by DM and SDV by CRA) at data point level as well as CRFs status (completed, on-going and query status) at patient level.
- Easy edit check setup – The system equips a sophisticated Graphic User Interface (GUI) for edit setup. From creating a simple range check or a complicated cross-form check, computer programming language is not required to set up edit checks. The simulation tool can test whether each edit check works prior to deployment!
- QC/SDV Planning – By simple clicks, the system can select key fields for 100% check or SDV and set xx% of fields for random check. This enables the Risk-Based Monitoring for which the Risk Score of unchecked fields will be calculated based on predefined importance score and the study level Risk Score will also be calculated accordingly.
- Query management – The system equips a comprehensive query management module for query release and resolve, email notification and complete audit trail.
- Source document uploading – Sites can upload the related documents to CIMS for a specific patient at specific time/form level (images, printouts of lab results, printout of source file, etc.). This unique feature makes CIMS more powerful than other systems in remote SDV, and query management.
- Customized reports – The system equips all different customized reports such as progress report (by center, by investigator etc.), query status report, AE report, individual patient profile as well as population based data display.
- Patient eCRF Book – The system can export eCRF book for each subject in PDF format which contains a full set of data for the subject.
- Standardized Data – The built-in SDTM mapper can map and create SDTM database with associated aCRFs and Define files.
- SAE Reporting – The SAE report can be generated automatically in standard regulatory required format (such as CIOM). Relevant information (demographics, medical history, concomitant medications, and labs) will be automatically filled in. Investigator can write narratives directly in the system, export the form, and submit to the authorities. The provides the most streamlined SAE reconciliation and SAE reporting process.