A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial according to the protocol and to report the data to the sponsor.
The data originator may be a human (e.g., the participant or trial staff), a machine (e.g., wearables and sensors) or a computer system from which the electronic transfer of data from one system to another has been undertaken (e.g., extraction of data from an electronic health record or laboratory system).
Examples of DATs include but are not limited to CRFs, interactive response technologies (IRTs), clinical outcome assessments (COAs), including patient-reported outcomes (PROs) and wearable devices, irrespective of the media used.