eCRF development and Data management
Cardialysis’ Data Management provides a variety of services. All services are targeted towards the quality, consistency and completeness of the study data.
Electronic Case Report Form (eCRF) design at Cardialysis starts with a review of the study protocol from a database designing perspective. During this review, Cardialysis identifies the data items to be collected and the frequency of collection with respect to the patients’ visit schedule. Cardialysis can then start drawing up the database requirements for the eCRF database:
- Structure of the eCRF components (events/visit, types of forms, item groups, items)
- Item characteristics (e.g., annotation, types, appearance, field length, mandatory or optional, etc.)
- Dynamic functionalities (e.g., enabling/disabling, repeating, calculations, etc.)
- Specification of system-generated checks (queries, messages or vetoes)
In cases where the Case Report Form (CRF) is designed by an external party, while Cardialysis provides data management and/or statistical services for the study, Cardialysis reviews the draft CRF with respect to:
- Consistency with the study protocol
- Clarity, uniformity, layout, necessity and order of questions
If database building is performed by Cardialysis, they will use XClinical’s Study Composer as the database development tool. Within this system, the eCRF structure and edit checks are defined as well as the roles and permissions. If required, a randomization module can also be built into the eCRF.
User Acceptance Test
When an electronic Case Report Form (eCRF) database is developed, whether by Cardialysis or any other external party, a User Acceptance Test (UAT) must be performed. Cardialysis will draw up the UAT Plan upfront. The UAT Plan consists of a general description of how the UAT is set up and of the test scripts to be used during the UAT.
Test scripts are written and reviewed for each UAT round. A complete UAT for an average study usually consists of three rounds. The complexity of the UAT Plan depends on the number of variables and edit checks in the CRF.
UAT findings are reported to the database programmers according to Cardialysis procedures. After the database changes have been made, the UAT findings are re-tested during a second UAT. Only after the last UAT results in zero findings can the eCRF be finalized and used by the sites.
Central Tracking System (CTS)
The Central Tracking System is a sophisticated automated system for tracking all pre-defined activities within a study. The tracking system is attached to the main study database to monitor the day-to-day progress of the study. It is also used to generate reports that are sent to the sponsor on a regular basis.
Query Resolution and Data Cleaning
Cardialysis continuously checks the electronic Case Report Form (eCRF) data to ensure that it is as accurate and clean as possible throughout the course of the study. This allows interim data analyses to be performed at pre-defined time points. Data ‘cleaning’ includes:
- Reviewing the sites’ answers to the automatically generated system queries e.g., on ranges, completeness, consistency, etc. when these are not automatically closed by the system
- Creating and reviewing manual queries based on additional automated data checks and database reports
- Reviewing text fields to prevent errors and to extract important data that cannot be detected by automated check rules, e.g. on protocol deviations, Adverse Events and “other (specify)” fields
- Signing/freezing/locking the forms