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Standards for the Management of Clinical Trial Data, why are they needed, what is needed ?
| Content Provider | Semantic Scholar |
|---|---|
| Author | Abousahl-Chaunu, Isabelle |
| Copyright Year | 2013 |
| Abstract | Ipsen has made the choice to replace its clinical data warehouse along with its underlying standard data model. The landscape of clinical trial data standards being quite complex, it appears critical, using the lessons learnt from our past experience at implementing Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), to thoroughly assess what is needed and why this is needed, using an holistic approach. We propose a method based on the review of existing data standards against requirements and process components, allowing an analysis of available solutions and gaps that is used in turn to drive the implementation and define our future data governance principles. The system will be setup as a hub for clinical trial data, based on an extensible and flexible data model driven by semantic. It is intended to support quality as well as speed of execution, from the recording of clinical trial data to its regulatory submission and publication for scientific and transparency purpose. |
| File Format | PDF HTM / HTML |
| Alternate Webpage(s) | https://www.lexjansen.com/phuse/2013/pp/PP11.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |