(a) When data captured on paper or in an electronic health record are manually transcribed into a computerised system (e.g., data acquisition tool), the need for and the extent of data verification should take the criticality of the data into account.
(b) Acquired data from any source, including data directly captured in a computerised system (e.g., data acquisition tool), should be accompanied by relevant metadata.
(c) At the point of data capture, automated data validation checks to raise data queries should be considered as required based on risk, and their implementation should be controlled and documented.