Conformance Rule Specifications
Conformances rule specifications were published for USDM v3.0 on 18th December 2024 and for USDM v4.0 on 3 June 2025. Subsequent to this the CORE executable versions of the rule specifications were developed and published in the CDISC library in December 2025.
During development of the executable rules there were several inconsistencies noted between the specification and executable rules. These are documented below and will be corrected in a future release of USDM.
Final CORE Rule ID | Reason for change | Old Textual statement of rule | New Textual statement of rule | Warning/Error | Warning/Error | Entity(ies) to which the rule applies | Attributes within the entity(ies) to which the rule applies | Version 3.0 | Old Version 4.0 | New Version 4.0 |
DDF00162 | This rule is superfluous as this is already checked implicitly in rule DD00187. Therefore the rule is not created. | When included in text, references to items stored elsewhere in the data model must be specified in the correct format. They must start with '<usdm:ref', end with either '/>' or '></usdm:ref>', and must contain 'klass="KlassName"', 'id="idValue"', and 'attribute="attributeName"/>' in any order (where "KlassName" and "attributeName" contain only letters in upper or lower case). |
| ERROR | ERROR | NarrativeContentItem | text | N | Y | Y |
DDF00168 | Narrative content is not defined within a study version - it is defined with a study definition document version - so this rule just checks that the referenced narrative content id is valid (i.e., it is defined within the study). | A piece of narrative content must only reference narrative content items that have been defined within the study version as the narrative content. | A piece of narrative content must only reference narrative content items that have been defined within the study. | ERROR | ERROR | NarrativeContent | contentItem | N | Y | Y |
DDF00182 | The change to study definition document was not updated in the rule description. | Within a study protocol document version, if a date of a specific type exists with a global geographic scope then no other dates are expected with the same type. | Within a study definition document version, if a date of a specific type exists with a global geographic scope then no other dates are expected with the same type. | WARNING | WARNING | StudyDefinitionDocumentVersion | dateValues | N | Y | Y |
DDF00184 | This rule was defined based on the assumption that the substance information would be an independent container of substance information in the API. Now it is superfluous as this is already checked implicitly in the schema schecking rule. Therefore, it is not created. | A substance must not references itself as a reference substance. |
| ERROR | ERROR | Substance | referenceSubstance | N | Y | Y |
DDF00188 | Corrected typo: 'either' instead of 'ether' | A planned sex must ether include a single entry of male or female or both female and male as entries. | A planned sex must either include a single entry of male or female or both female and male as entries. | ERROR | ERROR | StudyDesignPopulation, StudyCohort | plannedSex | N | Y | Y |
DDF00196 | An amendment may have changes that affect sections in different documents, and section numbers/titles may not be consistent across documents. | There must be a one-to-one relationship between referenced section number and title within a study amendment. | There must be a one-to-one relationship between referenced section number and title within any study definition document affected by a study amendment. | ERROR | ERROR | DocumentContentReference | sectionNumber, sectionTitle | N | Y | Y |
DDF00197 | The rule description indicates an error but the rule type was set to "WARNING". This will be changed to "ERROR". The rule is fully executable in the core engine. | A study definition document version must not be referenced more than once by the same study design. | A study definition document version must not be referenced more than once by the same study design. | WARNING | ERROR | ObservationalStudyDesign, InterventionalStudyDesign | documentVersions | N | Y | Y |
DDF00232 | The decode value can also be "Not Applicable". Therefore, validating based on the code (as we do in all other rules) is better. We allow for missing study phase for observational trials. So statement is more specific to indicate that. | An observational study (including patient registries) is expected to have a study phase decode value of "NOT APPLICABLE". | If a study phase is specified for an observational study (including patient registries) it is expected to have a study phase value indicating "Not Applicable". | WARNING | WARNING | ObservationalStudyDesign | studyPhase | N | Y | Y |
DDF00250 | This rule is not needed because checking for the use of each criterion in a population or cohort is done by DDF00158 and use in not both population and cohort is done by DDF00159. Therefore the rule is not created. | An eligibility criterion must be referenced by either a study design population or cohorts, not both. |
| ERROR | ERROR | StudyDesignPopulation, StudyCohort | criteria | N | Y | Y |
DDF00251 | Removed superfluous space between 'are' and 'defined'. | A study cohort must only reference indications that are defined within the same study design. | A study cohort must only reference indications that are defined within the same study design. | ERROR | ERROR | StudyCohort | indications | N | Y | Y |
DDF00245 | If the same section contains multiple pieces of narrative content with the section number only displayed for the first, it's allowable for the non-displayed section numbers to be the same as the displayed one. | Within a document version, the specified section numbers for narrative content must be unique. | Within a document version, the specified displayed section numbers for narrative content must be unique. | ERROR | ERROR | NarrativeContent | sectionNumber | N | Y | Y |
DDF00010 | The rule was meant to test the name attribute within each class to have unique values. This was interpreted incorrectly when defining the rule. | The names of all child instances of the same parent class must be unique. | The names of all instances of the same class must be unique. | ERROR | ERROR | All | name | Y | Y | Y |
DDF00020 | Attribute name was incorrect. | If the reason for a study amendment is 'Other' then this must be specified (attribute reasonOther must be completed), and vice versa. | If the reason for a study amendment is 'Other' then this must be specified (attribute otherReason must be completed), and vice versa. | ERROR | ERROR | StudyAmendmentReason | code, otherReason | N | Y | Y |
DDF00084 | It's possible for there to be more than one primary objective. | Within a study design there must be exactly one objective with level 'Primary Objective'. | Within a study design there is expected to be exactly one objective with level 'Primary Objective'. | ERROR | WARNING | Objective | level | Y | Y | Y |
DDF00104 | Incorrect codelist reference. The codelist is DDF not SDTM. | A timing's relative to/from property must be specified using the Timing Relative To From Value Set Terminology (C201265) SDTM codelist. | A timing's relative to/from property must be specified using the Timing Relative To From Value Set Terminology (C201265) DDF codelist. | ERROR | ERROR | Timing | relativeToFrom | Y | Y | Y |
DDF00122 | It was not indicated in the rule that the codelist was extensible which is inconsistent with the other rules. | A study design's characteristics must be specified according to the Study design characteristics (C207416) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | A study design's characteristics must be specified according to the extensible Study Design Characteristics Value Set Terminology (C207416) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | StudyDesign | characteristics | Y | N | N |
DDF00136 | It was not indicated in the rule that the codelist was extensible which is inconsistent with the other rules. | An encounter's contact modes must be specified according to the Mode of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | An encounter's contact modes must be specified according to the extensible Mode of Subject Contact (C171445) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | Encounter | contactModes | Y | Y | Y |
DDF00164 | It is allowed to store a section number without having to display it. | If a section number is to be displayed then a number must be specified and vice versa. | If a section number is to be displayed then a number must be specified. | ERROR | ERROR | NarrativeContent | sectionNumber, displaySectionNumber | N | Y | Y |
DDF00165 | It is allowed to store a section title without having to display it. | If a section title is to be displayed then a title must be specified and vice versa. | If a section title is to be displayed then a title must be specified. | ERROR | ERROR | NarrativeContent | sectionTitle, displaySectionTitle | N | Y | Y |
DDF00180 | The word 'product' was omitted for 'administrable product property'. | An administrable product property type must be specified according to the extensible administrable property type (C215479) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | An administrable product property type must be specified according to the extensible administrable product property type (C215479) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | AdministrableProductProperty | type | N | Y | Y |
DDF00181 | The change to study definition document was not updated in the rule description. | Date values associated to a study protocol document version must be unique regarding the combination of type and geographic scopes of the date. | Date values associated to a study definition document version must be unique regarding the combination of type and geographic scopes of the date. | ERROR | ERROR | StudyDefinitionDocumentVersion | dateValues | N | Y | Y |
DDF00145 | Not implementable for range and quantity for version 3. Therefore, this rule will be only valid for Quantity. The only version 3 use of Range that allows a unit is for planned age and DDF00111 already checks terminology for planned age unit. | A unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | A quantity's unit must be coded according to the extensible unit (C71620) SDTM codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | Range, Quantity | unit | Y | N | N |
DDF00199 | The word 'amendment' was omitted in 'An study impact type'. | An study impact type must be specified according to the extensible study amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | A study amendment impact type must be specified according to the extensible study amendment impact type (C215481) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | StudyAmendmentImpact | type | N | Y | Y |
DDF00226 | The subtype codelist was incorrectly referred to as type codelist. | A observational study design's sub types must be specified according to the extensible observational study design type (C215486) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | An observational study design's sub types must be specified according to the extensible observational study design subtype (C215486) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | ObservationalStudyDesign | subTypes | N | Y | Y |
DDF00259 | It was not indicated in the rule that the codelist was extensible which is inconsistent with the other rules. | A study role code must be specified according to the (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | A study role code must be specified according to the extensible study role code (C215480) DDF codelist (e.g. an entry with a code or decode used from the codelist should be consistent with the full entry in the codelist). | ERROR | ERROR | StudyRole | code | N | Y | Y |
DDF00075 | In version 4 children are also an option and either children or other references should be referenced (See DDF00160). Therefore, this rule is not valid for version 4. A new rule including children and timeline is added instead for version 4 as DDF00263. | An activity is expected to refer to at least one procedure, biomedical concept, biomedical concept category or biomedical concept surrogate. | An activity is expected to refer to at least one procedure, biomedical concept, biomedical concept category or biomedical concept surrogate. | WARNING | WARNING | Activity | definedProcedures, biomedicalConcepts, bcCategories, bcSurrogates | Y | Y | N |
DDF00111 | The textual statement of the rule indicates a warning, but the rule type was set to "ERROR". This will be changed to "WARNING" in alignment with the rule description. | The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) SDTM codelist. | The unit of a planned age is expected to be specified using terms from the Age Unit (C66781) SDTM codelist. | ERROR | WARNING | StudyDesignPopulation, StudyCohort | plannedAge | Y | N | N |
DDF00080 | This rule should only be applicable to the main timeline. Therefore the definition is made more precise. | All scheduled activity instances are expected to refer to an epoch. | All scheduled activity instances in the main timeline are expected to refer to an epoch. | WARNING | WARNING | ScheduledActivityInstance | epoch | Y | Y | Y |
DDF00213 | The controlled terminology does not indicate that a single group design should only include 1 intervention. Only for cross-over, parallel and factorial more than 1 intervention is described. So we decided to limit the description to that to limit any overreporting. | If the intervention model indicates a single group design then only one intervention is expected. In all other cases more interventions are expected. | If an interventional model indicates a cross-over, parallel or factorial design then more than 1 intervention is expected. | WARNING | WARNING | InterventionalStudyDesign | model | N | Y | Y |
DDF00263 | NEW RULE: created by splitting DDF00075 by USDM version (and allowing children for v4). See issue described for DDF00075. | An activity is expected to refer to at least one procedure, biomedical concept, biomedical concept category, biomedical concept surrogate, child activity, or timeline. | An activity is expected to refer to at least one procedure, biomedical concept, biomedical concept category, biomedical concept surrogate, child activity, or timeline. | WARNING | WARNING | Activity | definedProcedures, biomedicalConcepts, bcCategories, bcSurrogates, children | N | Y | Y |