ICH E6(R3) – 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 an electronic transfer of data from one system to another (e.g., extraction of data from an electronic health record or laboratory systICH E6(R3) – 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 an electronic transfer of data from one system to another (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), patient-reported outcomes (PROs), clinical outcome assessments (COAs) and wearable devices, irrespective of the media used.