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This article is put forward on behalf of the Quanticate CDISC Working Party and the work they have been doing on standardizing processes across the Data Management and Statistical Programming functions within Quanticate.
As part of the recently launched Centralized Service Provision (CSP) approach to clinical data outsourcing at Quanticate, we have been looking at approaches that enable cross-functional efficiencies at a task level. We have explored these efficiencies with the use of CDISC (Clinical Data Interchange Standards Consortium) CDASH standards when linking processes across clinical data management and clinical programming.
Material / Methods
SDTM is the most stable and better understood of the CDISC Clinical Data Standards. SDTM is very prescriptive and, although there is ‘wiggle room,’ there is not as much as if you design your database from scratch. Understanding this, and developing a solution that works as a data collection and cleaning tool, can present quite a challenge. This is where the CDASH standard comes in. CDASH is designed with the end goal of the SDTM data structure and is written to support Clinical Report Form (CRF) and database design; it provides a platform to enable these data collection tools to be built in an SDTM-friendly manner. This was demonstrated when the Clinical Data Management team at Quanticate wanted to build a set of standard CRF pages and the database that would sit behind them to CDISC standards.
Process & Results
Using the CDASH standards to facilitate discussion, and keeping one eye on the SDTM IG, each domain was considered in turn. Certain domains such as ECG and Laboratory Data prompted a lot of discussion as CDASH recommends various ways of capturing those data. We decided to build pages for each scenario, and let each sponsor dictate how they wanted these pages to be defined (although still within the CDASH / SDTM standards framework as far as possible).
We have built a set of database and CRF pages with associated validation checks that are robust enough to be re-used as required. The process consolidated the CDASH / SDTM knowledge of all those involved and prompted a lot of discussion about which data items should be included in the database design and what should be omitted for the time being.
SDTM Implementation Guide 3.1.1