2022年9月13日 · Industry-wide collaboration is essential in developing a tool that is widely accepted and broadly used by stakeholders. The TFL Designer is an COSA-approved open-source software project intended to create TFLs and generate associated metadata that supports clinical trial data analysis and reporting. TFL Designer Workshop

This page contains documentation on the WS6 TFL Metadata and how it uses and extends ARM Define.xml. The working assumption is that the TFL Engine receives its metadata as an extended ARM Define-XML which is then converting into a set of tables (referred to as the TFL Metadata Views). File Microsoft Word Document WS6_TFL_define_XML_Elements.docx

This paper outlines an approach to TFL automation that involved creation of the CDISC Analysis Results Metadata at the start of the process, not the end, and uses this metadata to generate the TFL. A SAS program structure is described that allows standard TFL to …

• Autogenerate ADaM artifacts from SDTM via CDISC 360 Process Flow for PoC [ADSL] • ADaM to TFL • Adjust TFL metadata to meet CDISC ARM v1.0 for Define-XML v2.0 standards • TFL Designer – will be conceptualize but team to hold on further development of PoC

By embracing the CDISC ARS Model, TFL Designer empowers users with enhanced interoperability, streamlined workflows, and improved data integrity. This commitment drives efficiency and compliance throughout the clinical research landscape, fostering a seamless and effective analysis and reporting environment.

Build an open-source TFL designer that can ingest available standards/templates from the CDISC library to design study-specific analysis output display (TFL shell) and in parallel generate machine-readable metadata that will facilitate generation of analysis dataset as well as the output of interest (TFL).

All You Need to Know about the New CDISC Analysis Result Standards!

In this paper, we will outline the current state of analysis results reporting, the goals of the ARS team, and propose a new workflow that will revolutionize the way analysis results are generated. Currently, analysis results are created as static PDF documents that …

2023年11月11日 · TFL部分包括常见TFL的编写以及注意事项，具体可以看下面截图部分. 我觉得这些table就能涵盖我们SP平时需要编写的80%的table了，同样的数据是用我dummy的数据或者使用《sdtm-adam-pilot-project-master》的数据,但是实际操作过程中跟真实工作没什么区别，虽然dummy的数据有很多逻辑上的bug，但是刚好锻炼大家review数据，发现问题的能力。 目前所有的视频课程如图： 下周我会把疗效部分的视频录制上传，涉及这张表（有视频），然后如何 …

• 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 will use the Community version of the TFL Designer to create system agnostic ARS metadata.