An upgraded version of software used for reporting clinical data provides for compliance with data integrity standards. The goal of the software--ClinPlus Report version 4.0--is two-fold: to aid in standards compliance in the conversion of study data to analysis-data-model data, prior to its conversion to submission-ready tables, listings, and graphs, and to aid in documenting the conversion process. Although it's largely considered a difficult process, adhering to Clinical Data Interchange Standards Consortium (CDISC) standards can aid in data integration in addition to access and review.
Version 4.0, via the optional Analysis Data Model (ADaM) Data Conversion and Reporting Toolkit with template library, provides documentation for the creation of tables and listings and the underlying ADaM data sets. Such documentation is key to meeting CDISC spec's for retaining the integrity of the original data in the SDTM domain, according to manufacturer DZS Software.
Researchers can generate ADaM data and safety tables/listings for submission-ready clinical study reports from SDTM data without additional programming. The proprietary conversion process can also be used to convert data structures other than SDTM. The library of more than 50 templates can be tailored and supplemented with safety and efficacy templates, as needed, for each sponsor.
CDISC last fall unveiled version 1.0 of its standard for the collection of safety data for clinical research studies. Called CDASH, for clinical data acquisition standards harmonization, the standard is intended to address the confusion caused by variation in data collection requirements across different research study sponsors. A specific target of the standard is electronic case report forms.
- here's DZS' release
- read the CDISC CDASH V 1.0 announcement (.pdf)