From: Data management in diabetes clinical trials: a qualitative study
Theme | Subtheme | Category |
---|---|---|
Clinical trial data collection | Data collection methods | Electronic records |
Paper-based records | ||
Data entry responsibility | Researchers | |
Data entry operators | ||
Technologies used in data management | Hardware | Personal computer |
Software | Statistical software | |
Data management software | ||
Telecommunication technologies | Intranet | |
Internet | ||
Data security and confidentiality management | Managerial dimension | Physical safeguards |
Closed-circuit television camera | ||
Data de-identification | ||
Physical dimension | Using safe file cabinets | |
Locking rooms | ||
Technical dimension | Using username and password | |
Using antivirus software | ||
Data backup | ||
Role-based access control | ||
Data quality management | Quality assessment during data collection | Accuracy |
Precision | ||
Timeliness | ||
Completeness | ||
Quality assessment during data entry | Consistency | |
Relevancy | ||
Data management standards | Data collection, storage, and exchange standards | Good Clinical Practice (GCP) |
Data coding and adverse event reporting standards | Food and Drug Administration (FDA) standard |