The role and importance of data management in clinical investigations
The high quality of clinical investigation data is critical for demonstrating the performance and safety of a medical device.
Variable listing in a structured, human, and machine-readable variable specification that supports customized programmatic data quality controls during the study.
General data protection regulation
Sensitive personal health data is being collected and processed in clinical investigations aiming to demonstrate the performance and safety of medical devices.
To ensure that an investigation complies with general data protection regulation (GDPR) systematic planning is needed.
Data traceability is a foundational principle for clinical investigations aiming to demonstrate the performance and safety of medical devices.
As several information systems are used in collecting and processing data, systematic planning is needed to ensure consistent implementation of traceability.
Labquality offers data management services as part of the wider CRO clinical investigations offering.
Markus Vattulainen, Data Manager, Labquality Oy, www.labquality.com