Once you have your CRF set up, both you and your investigators will be able to input data according to the designated access levels you’ve assigned. All users can access from desktop, laptop or tablet as required.
- In the example here we can see the the subjects, ID, and number of visits (in this case 3) with colour coded status.
- This overview screen offers 1-click access to each section e.g. visit, related CRF Log (for example, Serious Event Log, Medication Log etc…) and Actions.
- The Actions drop-down offers reporting and subject related information.
Critical in any EDC application is the ability to monitor progress and troubleshoot. Query List, the dedicated query management and resolution tool, enables different roles/users to troubleshoot queried data within their security level. Data Managers and monitors can analyze data input once entered, raise an issue log to query questions or groups of questions, filter queries to meet specific requirements and audit via issue reports.
From the ‘Manage a CRF’ section you can also output reports: All data is mapped using CDISC’s ODM model and we have incorporated the CDISC Study Data Tabulation Model (SDTM). This can be reviewed in study (once setup) using the Annotated .pdf option. We then have SDTM reporting outputs in either .xls or SAS.
Reporting outputs offer direct XML ODM Transactional and Snapshot outputs. Alternatively, data can be translated to a SAS Export file or simply outputted directly to an excel spreadsheet. An audit trail provides reporting capability on a specific question or visit level. Results can be filtered to focus the information as required.