TFL Designer Community Release Version 1.0.0

15 August 2024

Description

Clymb Clinical hosted this webinar to introduce the TFL Designer Community Version 1.0.0. This session showcased how TFL Designer can significantly streamline the creation of Tables, Figures, and Listings (TFL) mock-up shells, aligning with the latest CDISC Analysis Results Standard (ARS). The webinar featured a live demonstration of the platform’s capabilities, including the automation of TFL design and analysis results metadata generation.

Key highlights included the introduction of the TFL Designer's template library, supporting statistical analysis and reporting, and the ability to export TFL shells in multiple formats, such as JSON and Excel. The session also emphasized the difference between the Community and Enterprise versions of TFL Designer, with Community version being offered as a free, web-based solution aimed at fostering collaboration and innovation within the CDISC community.

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Q&A

My organization has different safety mockups than the TFL designer template (e.g., demographic table). In this case, do we need a protocol template, or will the TFL designer teamwork with the organization and create organizational-specific templates?

In the TFL Designer Community, you can build your own shell that is in line with your organization preference. Once you have built the shell, you can save the shell as a template. This template will then become available under "My Library".

Would it be possible to automate upload of external metadata (instead of manually from the xls file), or would that not make sense?

For the Community version, it will be a manual effort. In our Enterprise version, we can connect to an external metadata repository and automatically ingest the metadata.

In my experience the TFL mocks are created early on, much earlier than the ADaM specs and metadata. How do you envision handling this?

The tool proactively lets you input ADaM metadata, even though TFL mocks are often created earlier. The idea is to build the metadata as you go, which then becomes available for downstream automation. While you may need to update ADaM specs later, the tool helps by allowing you to ingest metadata into various formats like JSON or Excel and build from there.

Do the community and enterprise versions have any differences in functionality?

Yes, there are differences. The Community version is a single-user instance with identical functionality for building shells and inputting metadata as the Enterprise version. However, the Enterprise version includes additional features: study import/export, version control, and multi-user collaboration. Please check our website for further details: https://clymbclinical.com/tfl-designer/

What I saw in the demo is a study-level configuration. Can we configure multiple analysis purposes within a study, for example, interim analysis or other purposes?

The current setup requires creating a new study for each reporting event. While the tool doesn’t currently categorize by reporting events within a single study, this could be built in the future based on user needs.

Can you still use the TFL automation if you have standard (validated) macros/packages?

Yes, you can use TFL automation with standard macros, but it depends on how your macros are structured and the parameters required. Some customizations might be needed depending on the complexity of your macros. The metadata can be integrated with your existing macros for automation.

For efficacy tables, are there any standard templates compared to FDA STF IG?

Currently, the templates are restricted to safety as per FDA STF IG. However, there are plans to expand the library to include efficacy tables over time. Contributions from the community, especially for specific therapeutic areas, are encouraged to help build a comprehensive template library.

When attaching a macro to the meta file for statistical analysis (e.g., p-values), how should validation be handled by the end user?

Validation depends on how you plan to use the meta file. The industry typically requires independent programming and validation of macros through a software development lifecycle. If the template or macro has been pre-validated and tested, it can be reused without duplicating validation efforts.

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