Table 2 Themes, subthemes, categories

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