SEND V4.0 – What to Expect and When to Expect It

SEND 4.0 has been in development for several years and aims to address many of the known issues and gaps identified in the previous versions of the standards. Getting a CDISC standard through the rigorous development, review and publication stages is a challenging and time-consuming process. Currently, SEND 4.0 is in the final stages of review by the CDISC SEND sub team and compilation of proof-of-concept (POC) datasets that cover new areas in the standard such as new domains, significant updates to existing domains or major changes in data modeling are being developed. From there, it will move to the CDISC Internal Review stage and then to full Public Review. Following resolution of comments on both review cycles, the final standard will be published. Based on a timetable shared in January 2025 by the CDISC SEND team, the current target date for publication of SEND 4.0 is June 2026.

After publication of the final version of SEND 4.0, FDA will work to publish dates on when data formatted according to the new standard will be accepted and eventually required for submissions sent to CDER and CBER. These dates will be published in the FDA Data Standards Catalog when they are available, and based on prior releases, could take 1-2 years or more from the time FDA is able to accept data formatted using a new standard to when it becomes a requirement.

There are numerous changes planned in the SEND 4.0 implementation guide, including the addition of new domains, removal of some domains used in SEND 3.X, significant changes to previously existing domains, and several modeling changes aimed at easing some of the pain points experienced by users of the previous SEND versions.

A list of the domains planned for addition and deprecation in SEND 4.0 is included below.

In addition to the domain level changes, there are many other proposed changes and expanded modeling examples, including several key changes to existing domains of note summarized below.

While SEND 4.0 remains in development into 2026 and is subject to change, there are several steps that sponsors, CROs, software vendors and other interested parties can take now to better understand and prepare for the proposed changes.

First, consider engaging with the CDISC SEND team to stay informed about the direction of the standard. You can gain early insight into the evolving SEND 4.0 implementation guide by joining a sub-team, attending full team meetings, or participating in the public review process. Input and feedback are needed to capture a broad range of perspectives prior to finalization of the standard. To join the CDISC SEND team, you can register as a volunteer with CDISC and indicate your interest in SEND.

Second, begin reviewing the proposed changes and assess how they might impact your organization’s data collection processes, SEND dataset creation workflows, and related systems. While the SEND 4.0 standard is not yet final, it’s not too early to be thinking about potential impacts, gaps and system/process changes that may need to be put in place to comply with future SEND 4.0 requirements.

Lastly, recognize that the changes proposed in SEND 4.0 are significant and will take time to fully understand and implement. Stay up to date on progress through CDISC and public review cycles and monitor for updated timelines related to final publication and subsequent FDA adoption.