Data Management is a fundamental part of a clinical trial because data is vital information and must be reliable and statistically sound. It is required for all the steps that make up the clinical trial process to ensure that data is collected, captured and presented properly. Data integrity is the cornerstone of CHRU’s clinical trials.
CHRU’s data management team is experienced in various data collection and reporting platforms which have ensured a consistent track record in quality data management. This has also allowed CHRU to maintain exceptional rates of data quality – over 98%. Attention to detail by the data team members has led to outstanding data management reports for CHRU’s sites. They ensure that the highest levels of data integrity are achieved.
The Data Management teams work with all CHRU departments, trial sponsors and networks to:
- Design the research tools or methods
- Set up processes to collect data
- Help study coordinators track processes
- Clean data for accurate recording
- Quality control the data and
- Report and analyse the data.
Data Management also:
- Reports to the Data Safety Monitoring Board (DSMB) and to the WHRG CTU
- Provides data for, and sometimes co-authors, academic publications
- Ensures that all information on trial participants remains confidential
- Trains CHRU staff members in data gathering and collation processes and
- Develops Standard Operating Procedures (SOPs) for clinical trials.