SEND

Conduct a proof-of-concept (POC) pilot early, within the development team, to prove the purpose and scope of the standard. After a standard is released and vendor tools are available in some form (e.g., beta version), a fit-for-use pilot may assist in testing the usefulness of the standard and providing requirements back into the development of the standard in time to inform the next release. Consider these pilots as important but optional steps in the SEND standards development process.

Each new SEND release must include an assessment and realignment with the SDTM model and the SEND standard. It should also include an assessment and statement of relationships to other standards, including incompatibilities with standards considered applicable for the scope of the new release (e.g., define.xml). From this assessment:

• Identify with which versions of standards the new release is compatible.
• Identify any new content that should be added to either the SDTM or SENDIG. 
• Document any temporary misalignment and future approach intended to address alignment issues (e.g., when a domain will be added to the SENDIG). The Known Issues section (generally part of Section 1) can be a good place to clarify this.
• Identify any cross-team topics or concepts as early as possible and submit for Global Governance Group (GGG) concept consultation.

The SEND Team will first consider inclusion in SENDIG, and use the following criteria to consider whether creation of a separate IG could be beneficial:

1. The endpoints are not particularly useful for general toxicology (repeat dose and carcinogenicity) studies.
2. The IG audience is a different set of scientists (and can be smaller than the audience for SENDIG).
3. Introductory sections would need to be written specifically for this audience’s use cases.
4. One large, all-encompassing IG would become too complicated for both the SENDIG audience and the separate IG audience.
5. Priorities and  timing of delivering solutions can be different, based on different audiences/study types (there are different drivers). If this is considered a new implementation for the industry, a separate lG is recommended and will give regulators the ability to reference it separately if desired. 

If these criteria are met, the next step is to begin to describe the “use case” that is different from the SENDIG to date. This will inform CDISC Library in the future. (CDISC Vision: One standard in CDISC Library with many use cases that each become a deliverable with domains/variables/examples to meet that specific use case).

When creating a separate IG, bear in mind the following cautions and considerations:

1. We must declare which standard versions are compatible (or why not).
2. We must ensure alignment of standards aligned. Whenever SENDIG is updated, it is likely that separate IGs will need to be updated. Minimally, we must evaluate compatibility across IGs with each release of SENDIG. (As mentioned above, it is an expectation of the SEND team that each release of SENDIG is realigned with the SDTM). 
3. With each new release of SENDIG, the team must plan to roll up separate IGs (as appropriate), and identify all variables or domains that should roll up from each separate IG for consideration in use with all SEND studies.
4. Consider the complexity of data standards references in the Data Standards Catalog (e.g., 25 ICH study types, each with a supported and mandated version). On the flip side, this is functional and provides accuracy.

Notes:

Separate IGs (although based upon SENDIG) will have their own version numbering and may be considered a "new" standard by regulators.

While developing a separate IG, the team should identify any domains or variables that should be considered for inclusion in SENDIG in future.

Use the following standard naming conventions for SENDIGs: Separate IGs will use the name SENDIG – nnnn, where nnnn assists in aligning the use of the guide with the International Council for Harmonisation (ICH) study type in the eCTD (electronic Common Technical Document) Module 4 Table of Contents.