Clinical Data Management (CDM) encompasses the entry, verification, validation, and quality control of data gathered..

Data privacy or information privacy is the relationship between collecting and disseminating data and the..

Use of standards has become increasingly widespread within clinical data management. There are few regulatory..

The ICH Guidance for Industry: E6 Good Clinical Practice defines the term “case report form” as, “A printed, optical,..

Safety data are reported and examined at various stages of an investigation and by different..

Recording and storing data in a controlled, consistent and reproducible manner for data retrieval and..

Closing or locking a study database is fundamental to preventing inadvertent or unauthorized changes once..