Key-Coded Data definition
Key-Coded Data means data that has the identity of the individual data subjects replaced with a unique subject identification code (that is not derived from information related to the individual data subject) and do not carry such direct personal identifiers as name, address, or national health number, where such coding restricts identification of data subjects’ personal information to specific individuals involved in the research project, such as clinical investigators, while still allowing for the addition of further research information as the study proceeds, clinical monitoring, and research oversight, and the ability to de-code data and re-identify data subjects permits auditing by drug regulatory authorities in order for them to verify the source and quality of safety and efficacy data collected during clinical trials and subsequently used in an application for a license to market a medicine; and