Packages

Work Package 9

Data management of the clinical trials

• Involves Partners ZYMX and Larix

Objectives:
The aim of this WP is to report and evaluate all clinical data that have been collected during the clinical trials.

Description of the Work:
Within this WP all clinical data concerning the disease will be collected, evaluated and reported. This requires a validated database system programmed in the SAS® software package, which is provided by the partner. The system includes an audit trail facility in compliance with regulatory requirements. This system will be used for defining the database structure, for handling data cleaning processes, and for final storing of the data. The statistical evaluation and presentation of the data will follow generally accepted standards. Larix will cover medical writing of the final integrated clinical report. All processes are covered by comprehensive standard operating procedures.

This WP will provide:

• Data:
  Data validation plan, design of edit checks, validation of data, code of medical history, AEs, concomitant medications, clean all data including lab data, generate and resolve queries, database audit, data transfer, generation of tables, listings and figures.
• Statistics:
  Statistical analysis plan, statistical analysis, result meeting, handling and presentation of data to the Data Monitoring Committee, programming and documentation according to regulatory standards and clinical reporting including the ICTR (Integrated Clinical Trial Report).
• Pharmacovigilance:
  Receipt and follow up of the SAEs (Serious Adverse Events) with the investigators, MedDRA (Medical Dictionary for Regulatory Activities) coding, medical evaluation, evaluation of expectedness, SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting, registration to Eudravigilance, creation of safety database and EU annual safety report preparation

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