CDMS with Clintrial
The Clintrial system provides roles-based modules that enable organizations to customize product configurations based on the functionality needed to perform specific tasks, including study design, data entry and data management.
- Enter. This module is used most often by data entry personnel to enter data from paper CRFs received from trial sites. The Enter module can be set up for single or double data entry (interactive or blind verification), and allows effective and flexible navigation of the clinical record forms.
- Manage. This module provides facilities for cleaning/validating data, performing global data changes, coding medical verbatim text automatically and interactively, and merging/moving cleaned data to separate data tables. It also provides batch loading of electronic records, laboratory data, clinical data records, and coding dictionaries.
- Retrieve. This module is used for flexible data access and extraction. The Clintrial Retrieve module provides four easy-to-use tools to create ad hoc listings and reports, and also enables users to save out those reports to multiple standard formats. Listing and report definitions can be stored in the Retrieve Library for future execution.
- Resolve. This extended module provides enhanced discrepancy management and resolution. It is designed for use by all project team members involved with the review of clinical trial data and the automatic or manual generation/resolution of questions about the data. The Clintrial Resolve module creates a permanent record for each data discrepancy created during the review and processing of clinical data.
- Classify. This extended module enhances the coding capabilities in Clintrial Manage to serve the needs of centralized coding groups within global research organizations. The Clintrial Classify module supports the development and validation of custom auto-coding algorithms, and has a workflow embedded within it to handle coding failures — by updating the dictionary, by issuing a discrepancy, or by manually applying codes. The Classify module also manages the dictionary and coding process transitions over time.
- Lab Loader. This extended module extends the batch loading capabilities in Clintrial Manage to provide enhanced client-based batch loading of laboratory test data and other types of external data. The Lab Loader module is used to define batch load format specifications, and includes a special pre-processing area which allows users to resolve discrepancies prior to loading data into the main databases.
- Multi-site. This extended module is used to perform inter-database operations so companies can share study metadata objects (i.e. panels, rules, derivations, etc) and clinical data among remote sites. The Multi-site module allows companies to perform data management functions on a global basis.