Search Results for "cdisc"

The "Smart Submission Dataset Viewer" allows to inspect CDISC SDTM, SEND and ADaM submission files in the modern CDISC Dataset-JSON 1.1 standard format. The "Smart Submission Dataset Viewer" has many features that go far beyond what reviewers at the regulatory authorities usually have available, this thanks to the use of the modern CDISC Dataset-JSON format (regulatory authorities still use the outdated XPT - Transport 5 - format).

This the old page for the "Smart Dataset-XML Viewer". It is a Java-based viewer for CDISC Submission files (SDTM, SEND, ADaM) in the new Dataset-XML Format. The Project has been renamed to "Smart Submission Dataset Viewer", and can be found at: https://sourceforge.net/projects/smart-submission-dataset-viewe/

This tool can be used to convert data collections based on IBM SPSS Statistics to the data standard for definition and exchange of clinical trials: CDISC ODM (Operational Data Model). Possible use-cases: - A project is running out of funding and scientific data collection should be performed in free available/open-source data capture systems - Advantages of reliable EDC systems like: Data security (role/right management), backup infrastructure, support of the entire clinical trial lifecycle, traceability of data (who has when entered what data or changed to what value with what reason) and compliant to regulatory requirements...

CI-Reports is helpful to generate a report of clinical trial data based CDISC SDTM. CI-Reports also provide the reports as PDF, Excel, Word, Flash, LibreOffice and RTF.