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E2E data standards, the need for a new generation of metadata repositories
| Content Provider | Semantic Scholar |
|---|---|
| Author | Zegher, Isabelle De |
| Copyright Year | 2015 |
| Abstract | This paper describes the implementation of E2E data standards within PAREXEL. It first introduces the rationale and the vision for E2E data standards (from protocol to submission), to ensure compliance in a cost effective way. And then it focuses on the core component of this implementation, i.e. the development of a metadata repository and the related data standards governance framework. The paper concentrates on the key functionalities needed for the metadata repository (MDR) we are deploying within PAREXEL and explains why we need more than CDISC data standards management in an MDR. And more particularly we explain How to author and maintain data standards content that ensures not only compliance to CDISC standards with data lineage between CDASH and SDTM, but also manages semantic enrichment implicit in the definition of SDTM and needed to be made explicit for (secondary) data analysis How to integrate such a metadata repository within operational reality, mainly at study set-up, through the definition and management of study instance metadata, as a machine readable form of parts of the protocol. In parallel we will touch on the impact on processes, from definition of data standards to enforcement within data operations. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://www.parexel.com/files/9014/4716/8945/PhUse_2015_-_E2E_Data_Standards_-_Paper_-_FINAL.pdf |
| Alternate Webpage(s) | https://www.lexjansen.com/phuse/2015/dh/DH04.pdf |
| Alternate Webpage(s) | https://www.lexjansen.com/phuse/2015/dh/DH04_ppt.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
