Oracle Clinical – Validation and Derivation Procedures

Validation and derivation procedures in Oracle Clinical are used to validate and process the data collected during a clinical study. These procedures help to ensure the accuracy and completeness of the data and support data analysis and reporting.

1. Data validation: Data validation procedures are used to check the data entered into the study forms for accuracy and completeness. The data validation rules defined in the Definition Subsystem are used to perform these checks and ensure that the data meets the specified criteria.
2. Data derivation: Data derivation procedures are used to create new data elements from the existing data collected in the study. For example, calculated fields or derived variables can be created to support data analysis and reporting.
3. Quality control: Quality control procedures are used to monitor the data collection and management process to ensure that the data is being collected and processed in accordance with the study design and defined workflows.

The validation and derivation procedures in Oracle Clinical provide a comprehensive set of tools for ensuring the accuracy and completeness of the data collected during a clinical study. These procedures support the data analysis and reporting process and help to ensure that the data collected is of high quality and can be used to support effective decision making.

Validation and Derivation procedures are created from Edit specifications defined in the Edit Specifications document. These specifications are scenarios of inconsistencies which may occur in a trial on the data provided on the CRF, based on which procedures need to be created to identify inconsistent data.