definiens: means data that has the identity of the individual data subjects replaced with a unique sub ject identification code ( that is not derived from information related to the individual data subject ) and do not carry such direct personal identifiers as name, add ress, or national health number, where such coding restricts identification of data subjects ’ personal informat ion to specific individuals involved in the research proje ct, such as clinical investigators, while still all owing for the addition of further research information as the stu dy proceeds, clinical monitoring, and research over sight, and the ability to de - code data and re - identify data su bjects permits auditing by drug regulatory authorit ies 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 t o market a medicine ; and ( d ) neither it nor any of its Affiliates has bee n debarred or is subject to debarment