Confimedis Plattform v3.14.0

Features

• Queries: Automated Queries with Data Quality Rules, Data Validation Plan, and Metadata Dictionary
  • The queries module now includes a Data quality view listing every field of the study together with the metadata that constrains its input. Quality rules can be enabled there so that a query is created automatically when data violates them.
  • Six rule types are derived from the form definitions themselves and can therefore be enabled without further configuration: Mandatory field, Data type, Code list, Value range, Condition, and Calculation. Enabling a rule applies it to the entire study, where it can then be overridden for an individual field.
  • A seventh type, Custom expression, allows arbitrary rules to be defined with the expression editor already known from conditions and calculations, for example for time-critical entries such as a serious adverse event (SAE) or a stopping criterion.
  • Every rule carries a template for the queries it creates and assigns responsibility through roles instead of users, so that it remains valid when team members change. Together with the existing Query assigned notification, the responsible person is informed automatically when a form is saved.
  • The same view also serves as a data validation plan (DVP) and, transposed, as a metadata dictionary with one row per field. Both can be grouped by any of their metadata columns and downloaded as a CSV file, for example for the trial master file.
  • All rules can additionally be evaluated on demand against all data a user has access to, optionally including rules that are not enabled yet, so that the effect of a rule can be assessed before enabling it. The resulting findings are counted per rule and field, can be inspected individually, and can be turned into a regular query.
  • Defining and enabling rules requires the new Manage quality rules permission, which is part of the default data manager role. Without it, the view remains readable while all inputs are locked.

Improvements

• Forms: Added new missing and status functions that give access to the missing reason and the status of a field, so that conditions, calculations, and quality rules can, for example, distinguish an unanswered field from one that was intentionally left empty.
• Subjects: Withdrawing an informed consent now marks the affected field as Withdrawn (previously, the withdrawal was recorded on the signature only). Since this status can be read in expressions, a quality rule with a custom expression can react to a withdrawal and, for example, create a query for the study team.
• Users: The permissions dialog now groups the permissions of a role by module, which makes the growing list easier to navigate.

Bug fixes

• Import: Fixed an issue where values from a CDISC ODM-XML file were imported as plain text instead of being converted to the data type of the respective field, which could lead to incorrect data type and value range validations for numeric fields.