Standards and release¶

Standards says which standards the rule belongs to, and under which identifier in each. It is what decides where the rule ships — a rule missing a standard is a rule nobody receives.

Standards:
- Organization: "CDISC"
  Standards:
  - Name: "SDTMIG"
    Version: "3.4"
    References:
    - Origin: "SDTM and SDTMIG Conformance Rules"
      Rule_Identifier:
        Id: "CG0270"
        Version: "1"
      Version: "2.0"

The three levels¶

Organisation — who publishes the standard. One rule may belong to several: a requirement that CDISC and PMDA both state is one rule with two organisation entries, not two rules.

field	is
`Organization`	`CDISC`, `FDA`, `PMDA`
`Standards`	the standards of that organisation this rule belongs to
`Rule_Ids`	identifiers at organisation level, where the organisation numbers rules itself

Standard — which standard, and which version of it.

field	is
`Name`	`SDTMIG`, `SENDIG`, `ADaMIG`, …
`Version`	`3.4`, `1.3`, … — a string, not a number
`Substandard`	a narrower standard within that one, where there is one
`References`	what ties this rule to the published rule list

Reference — the published rule this one implements.

field	is
`Origin`	the document the rule list comes from — `SDTM and SDTMIG Conformance Rules`
`Version`	the version of that list, not of the standard — `2.0`
`Rule_Identifier`	`Id` and `Version` of the published rule — `CG0270` version `1`

⚠ Three different Version fields sit within a few lines of each other, and they mean different things: the version of the standard (3.4), the version of the rule list (2.0), and the version of the published rule (1). Getting them crossed is the easiest mistake in this block, and nothing detects it — the rule still loads, still runs, and is filed under a standard version it does not belong to.

One rule, several versions¶

Most rules belong to several versions of the same standard:

Standards:
- Organization: "CDISC"
  Standards:
  - Name: "SDTMIG"
    Version: "3.4"
    References: [ ... ]
  - Name: "SDTMIG"
    Version: "3.3"
    References: [ ... ]
  - Name: "SDTMIG"
    Version: "3.2"
    References: [ ... ]

Each version listed is a version the rule will be offered to. Listing one it does not apply to ships a rule that will report findings a sponsor on that version should never see; omitting one it does apply to silently withholds the check from those sponsors.

List a version only if you have checked the guidance for that version. Each one gets its own citation, and if the wording of the requirement changed between versions, the check has to be right for all of them — or the rule has to be split.

A note on the shipped form¶

The authored key is Standards:. In the generated packages the same tree appears under Authorities, and the Citations arrays that live in the docs sidecar are folded back into their References.

You never write that form — but if you are reading a shipped package and looking for the block you authored, that is where it went.

Next: back to Anatomy of a rule, or on to Scenarios to prove the rule works.