Data collection and management
Data management ensures that the participant data collected as part of a clinical trial are of highest quality and have been collected in compliance with the appropriate regulations governing the management of data.
It is essential to be aware of the data management regulatory framework operating in the region in which your trial is being conducted, particularly as relates to privacy. Widely recognized guidelines and regulations include those of the ICH and the FDA.
- Define the data requirements for the trial, which are explicitly presented or implied in the trial protocol – i.e. what data is needed and when.
- Build and test the trial database. It is important that testing is thorough and is undertaken by individuals representing the end users.
- Develop the data handling specification (i.e. data entry and data review procedures and methods)
- Establish data management plan
- Ensure the requisite computer infrastructure is available (eg. hard drives, back-up capability etc.)
- Plan the data management staff and training
- Test the computer systems
- Test and confirm the database and data management decisions
- Set up the project team by authorizing users and organizing training
- Load static data (e.g. final randomization codes, investigator details)
- Data collection: data will be collected by the sites and received and tracked by the data management team
- Data collation and confirmation: data will be organized according to the data management plan and reviewed to confirm quality
- Database lock after finalizing and confirming trial database
- Export data for statistical analyses
- Ensure organized storage of data in compliance with regulatory requirements
- ICH GCP Guidelines
- International Epidemiological Association Field Trials of Health Interventions: A Toolbox
- WHO TDR Implementation Research Toolkit – Research Methods and Data Management
- Data management and Case Report Form design templates (in Clinical Trial Planning, Oxford University Hospitals)
- Variety of data entry and management templates available from University of Rochester Study Documentation Tool Box
- American Society of Clinical Oncology (ASCO) Clinical Trial resources – Data Management
- Project REDCap (electronic data collection software)
- Data Management Tips available from NIH NIA Clinical Research Study Investigator’s Toolbox
- Data Management Plan Template from NIH NIDCR Toolkit for Interventional Studies