With collaboration between sponsors and Contract Research Organizations (CROs) becoming ever more common, the standardization of nonclinical data between sponsors and regulatory bodies is, in turn, becoming more regulated, to ensure consistency of communicated data. In a recent blog post, we talked about scientific data formats for biomolecular data storage, (link to blog post), but one of the things our customers are concerned about is the forthcoming requirement defined by the Clinical Data Interchange Standard Consortium for nonclinical datasets, Standard for Exchange of Nonclinical Data (SEND). This is an initiative to standardize presentation of datasets for regulatory submissions and data interchange between organizations to ensure that they can communicate more clearly on their research data.
Why SEND is Necessary
Many organizations are preparing to have a SEND solution implemented for all studies intended for submissions that start on or after December 18, 2016. The CDISC SEND implementation guide defines a common data model which enables companies involved in pharmaceutical R&D to exchange data in a standardized and consistent format, improving communication, reducing error and enabling the development of software tools which can make better use of these data. The package contains several components but the main focus is on individual study endpoint data, mapped to domains with a number of variables associated with them.
Terms are standardized within a SEND package by using Controlled Terminology (CT), to ensure that when referring to a common base concept, everyone calls it the same thing. These can be specified for a variable within a domain to indicate that there are specific terms used for that variable; CT is extensible or not depending on the implementation.
As an example, the Pharmacokinetic Concentrations domain model defines a number of variables to include when reporting concentration data, such as the subject, analyte, matrix, result, etc. to describe each reported concentration. Variables within these domains correspond to a SDTM variable role and are usually prefixed with the domain code, so the analyte name will be assigned the label PCTEST.
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Our Efforts to Implement CDISC SEND
So, here is what we are doing to implement CDISC SEND within our premier bioanalytical data management tool, the Thermo Scientific Watson LIMS software. For customers of Watson LIMS software versions 7.4.1 and 7.4.2, we have released the CDISC Exporter 1.0 tool. This establishes a connection to a Watson LIMS software version 7.4.1 or 7.4.2 series database and exports data according to certain supported SEND domain models. These domain models include Pharmacokinetic Concentrations (PC), Pharmacokinetic Parameters (PP), Laboratory Test Results (LB) [immune response assay results], Trial Arms (TA), Demographics (DM), and Subject Elements (SE). In the upcoming Watson LIMS software version 7.5, we will be building in native CDISC SEND support to make it easier to report the domain model data.
Of course, regulations may change and specific requirements may be modified. You may want to look at the Pharmaceutical Users Software Exchange site which features a lot more detailed information, and keep up-to-date with our Informatics and Data Management tools by visiting our Pharmaceutical Data Management Community.
And, if you have specific questions about the implementation of SEND in our Watson LIMS software, please ask us in the comments section below; we are always happy to answer your questions.