Материал: part03

- Standard -​

the Patient's identity. May be multi-valued if successive​ de-identification steps have been performed.​

Note​

1.​This may be used to describe the extent or​ thoroughness of the de-identification, for example​ whether or not the de-identification is for a "Limited​ Data Set" (as per HIPAA Privacy Rule).​

2.​The characteristics of the de-identifying equipment​ and/ortheresponsibleoperatorofthatequipmentmay​ be recorded as an additional Item of the Contributing​ Equipment Sequence (0018,A001) in the SOP​ Common Module. De-identifying equipment may use​ a Purpose of Reference of (109104, DCM,​ "De-identifying Equipment").​

Required if Patient Identity Removed (0012,0062) is present and​ has a value of YES and De-identification Method Code Sequence​ (0012,0064) is not present. May be present otherwise.​

- Standard -​

Note​

Previously, Other Patient IDs (0010,1000) was included in this table. This Attribute have been retired. See PS3.3 2017a.​

C.7.1.1.1 Patient Module Attributes​

C.7.1.1.1.1 Patient Breed Description and Code Sequence​

The breed of an animal, if known, shall be encoded in either Patient Breed Description (0010,2292) or Patient Breed Code Sequence​ (0010,2293) or both.​

In the case of a mixed breed, it shall be either:​

1.​described in plain text in Patient Breed Description (0010,2292), e.g., "Border Collie American Bulldog mix", or just "Mixed", or​

2.​coded as multiple specific breeds by composing the mix as multiple Items of Patient Breed Code Sequence (0010,2293), e.g.,​ (132561000, SCT, "Border Collie dog breed") followed by (132534000, SCT, "American Bulldog breed"), or​

3.​encodednon-specificallywithacodethatmeans"mixedbreed"oftheappropriatespecies,asdefinedinCID7486“MixedBreeds”,​ which is included in CID 7480 “Breed”, e.g., (132619000, SCT, "Mixed breed dog").​

Note​

The absence of a value for both Patient Breed Description (0010,2292) and Patient Breed Code Sequence (0010,2293)​ implies that the breed is unknown, not that it is mixed.​

C.7.1.1.1.2 Responsible Person Role​

Defined Terms:​

OWNER​

PARENT​

CHILD​

SPOUSE​

SIBLING​

RELATIVE​

GUARDIAN​

CUSTODIAN​

AGENT​

INVESTIGATOR​

VETERINARIAN​

C.7.1.1.1.3 Patient Species (Taxonomic Rank Value)​

If the species is not known then the Patient Species Description (0010,2201) or Patient Species Code Sequence (0010,2202) may​ describe a more general taxonomic rank value, such as a genus or subgenus, family or subfamily.​

- Standard -​

Note​

E.g., "Mus" rather than "Mus musculus".​

If the subspecies is known then the Patient Species Description (0010,2201) or Patient Species Code Sequence (0010,2202) may​ describe the subspecies.​

Note​

E.g., "Canis lupus familiaris" rather than "Canis lupus".​

C.7.1.1.1.4 Patient Strain and Genetic Modifications​

The strain of an animal (group of animals that is genetically uniform), if known, may be encoded in Strain Description (0010,0212).​ The nomenclature used may be encoded in Strain Nomenclature (0010,0213). A precoordinated code identifying the strain may be​ encoded in Strain Code Sequence (0010,0219).​

Defined Terms for Strain Nomenclature (0010,0213) and Genetic Modifications Nomenclature (0010,0223):​

MGI_2013​International Committee on Standardized Genetic Nomenclature for Mice, Rat Genome and Nomenclature Committee.​ MGI-Guidelines for Nomenclature of Mouse and Rat Strains. 2013/10. Available from: http://www.informatics.jax.org/​ mgihome/nomen/strains.shtml​

Note​

•​A pair of text and nomenclature Attributes are used, since standard nomenclatures typically define values that are con-​ structed from multiple components, and do not distinguish between value and meaning. These are distinct from the preco-​ ordinated codes used in Strain Code Sequence (0010,0219).​

•​Some strain and genetic modification nomenclatures make use of superscripts. To encode these superscripts consistently​ in an unformatted string, the convention of enclosing the superscript text in "<" and ">" pairs may be used. E.g., "D2.B6-​ Ahrb-1/J" would be encoded as "D2.B6-Ahr<b-1>/J".​

•​Relevant information that is not encoded in the formal description of the strain (i.e., not defined in the nomenclature used),​ such as the number of transgenes, may be encoded as plain text in Strain Additional Information (0010,0218).​

The strain of an animal may be more specifically identified by the Attributes within Strain Stock Sequence (0010,0216).​

Note​

•​The MGI-Guidelines for Nomenclature of Mouse and Rat Strains recommends the use of the laboratory codes assigned​ by the Institute of Laboratory Animal Research (ILAR). See the International Laboratory Code Registry (ILCR) http://​ dels.nas.edu/global/ilar/lab-codes.​

•​Because allele names are closely tied to gene names/symbols it is necessary to have a unique and permanent code for​ any allele that is part of a genotype of interest. For mice, MGI is the authoritative source of the nomenclature for genes​ and alleles and maintains unique, permanent codes for these entities. The MGI provides a report of all precoordinated​ MGIcodesthatareassignedtospecificstrainsathttp://www.informatics.jax.org/downloads/reports/MGI_Strain.rpt.These​ may be used in Strain Code Sequence (0010,0219) and Genetic Modifications Code Sequence (0010,0229) with a coding​ scheme of "MGI".​

•​Another source of pre-coordinated codes for strains is the NCI Thesaurus, which includes a snapshot of strains from the​ International Mouse Strain Resource (IMSR), as children of (C14421, NCIt, "Inbred Mouse Strains"). See http://​ ncit.nci.nih.gov/ncitbrowser/pages/concept_details.jsf?dictionary=NCI_Thesaurus&code=C14421.​

•​For example, a C57BL/6J mouse strain from The Jackson Laboratory might be identified as:​

Strain Description (0010,0212) = "C57BL/6J"​

Strain Nomenclature (0010,0213) = "MGI_2013"​

Strain Code Sequence (0010,0219)​

- Standard -​

>Code Value (0008,0100) = "3028467"​

>Coding Scheme Designator (0008,0102) = "MGI"​

>Code Meaning (0008,0104) = "C57BL/6J"​

Strain Stock Sequence (0010,0216)​

>Strain Stock Number (0010,0214) = "000664"​

>Strain Source (0010,0217) = "Jrep"​

>Strain Source Registry Code Sequence (0010,0215)​ >>Code Value (0008,0100) = 126850​

>>Coding Scheme Designator (0008,0102) = "DCM"​ >>Code Meaning (0008,0104) = "ILCR"​

•​For example, a FVB/N mouse with a Tg(MMTV-Erbb2*)NDL2-5Mul transgene might be identified as:​ Strain Description (0010,0212) = "FVB/N-Tg(MMTV-Erbb2*)NDL2-5Mul"​

Strain Nomenclature (0010,0213) = "MGI_2013"​

Genetic Modifications Sequence (0010,0221)​

>Genetic Modifications Description (0010,0222) = "Tg(MMTV-Erbb2*)NDL2-5Mul"​

>Genetic Modifications Nomenclature (0010,0223) = "MGI_2013"​

>Genetic Modifications Code Sequence (0010,0229)​ >>Code Value (0008,0100) = "3793949"​ >>Coding Scheme Designator (0008,0102) = "MGI"​

>>Code Meaning (0008,0104) = "Tg(MMTV-Erbb2*)NDL2-5Mul"​

In this example, a precoordinated code for the genetic modification is defined in MGI, but not for the mouse strain.​

C.7.1.2 Specimen Identification Module​

Retired. See PS3.3-2008.​

Note​

The functionality of the Specimen Identification Module has been replaced by the Specimen Module. See Section C.7.6.22.​

C.7.1.3 Clinical Trial Subject Module​

Table C.7-2b contains Attributes that identify a Patient as a clinical trial or research Subject.​

Table C.7-2b. Clinical Trial Subject Module Attributes​

- Standard -​