eTFL Portal
The eTFL Portal consists of ready-to-use, ARS-compliant packages. Each package is based on an analysis concept and includes:
- Display
- ADaM Dataset and Metadata
- Analysis Results Metadata
- Analysis Results Dataset
These packages and their contents are examples and are not meant to imply that any particular layout or analysis plan is preferable over another. To facilitate broad use, initial packages were developed based on safety analysis displays from the ARS v1.0 User Guide and the FDA Standard Safety Tables and Figures Integrated Guide. The following guiding principle was followed during development:
- Version 1.0 of the Analysis Data Model Metadata Submission Guidelines (ADaM-MSG) was used as a reference implementation, with ADaM datasets from the CDISC Pilot Study adapted to meet the requirements of each display and analysis concept.
CDISC has partnered with Clymb Clinical to instantiate the first version of the ARS-compliant packages in the eTFL Portal. The CDISC eTFL Portal Team can use the Community version of the TFL Designer to create system agnostic ARS metadata.
To provide feedback on the content of the eTFL Portal please follow the review instructions on the CDISC Wiki eTFL Portal Home Page.
Vendor Neutrality Disclaimer
CDISC is a vendor-neutral and technology-inclusive organization focused on promoting the use of standards to improve the quality and efficiency of research. CDISC does not endorse any specific vendor or technology in the use of its standards.