Table 5 Data management system

General and technical features

• Name: RDE-LIGHT version 1.5

• Compliance with good clinical practice (ICH E6 GCP)

• Presence of an audit trail

• Proprietary remote data entry system based on HTML forms

• Developed, validated and maintained by the Clinical Trials Unit, Medical Center, University of Freiburg

Additional documents to be created for more detailed documentation

• Data management plan for details on procedures, responsibilities, etc.

• Database plan for the description of technical specifications of the database and the e-forms (variable names, attributes, and data entry checks)

• Data validation plan

• Data management report for documentation of performance of data management and deviations from the data management plan, if any

Additional measures to promote data quality and integrity

• Programming of range checks for entered values at the CRF level

• Validation of the trial database and edit checks of the e-forms before any data entry is performed

• Documented training of any data entry personnel before access to the trial database is given

• Review of the data for completeness, consistency, and plausibility using the SAS software. The checks to be programmed will be specified beforehand in the data validation plan.

• Implementation of a query management, i.e., after running the check programs, the resulting queries will be sent to the investigator for correction or verification of the documented data

• Validation of all programs that can be used to influence the data or data quality (e.g., data validation programs, programs for CRF/query tracking, programs for import of RDE-LIGHT data into SAS or for import of external data)

• Source data verification (SDV) checks by the clinical research associate (100% SDV checks for critical data points)