Data Management at the Centre for Clinical Trials Münster covers the complete range of GCP-compliant data management tasks from the planning phase to the final trial report. For this purpose, Data Management works closely with the centre’s functional units such as Monitoring, Pharmacovigilance and Central Trial Management as well as investigators, chief investigators and biometricians. Quality assurance and quality control processes are established to control clinical trial data and assure their validity.
Data Management provides the following services:
During the planning phase
Data Management provides the following services:
During the planning phase
- Design and preparation of Case Report Forms (paper or electronic)
- Preparation of Data Management Plan and Data Validation Plan
- Design, set-up and validation of the study database
- Maintenance of the study database (e.g. database updates due to protocol amendments)
- Data capture / data entry
- Data cleaning and query management
- Coding
- AE / SAE reconciliation (in cooperation with the Pharmacovigilance unit)
- Database closure