SDTM.MI

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	MI	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	MI	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	MI	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	MI	MISEQ	Sequence Number	Num		Identifier	Req	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	MI	MIGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject. This is not the treatment group number.
6	MI	MIREFID	Reference ID	Char		Identifier	Perm	Internal or external specimen identifier. Example: Specimen barcode number.
7	MI	MISPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number from the MI Findings page.
8	MI	MITESTCD	Microscopic Examination Short Name	Char	C132263	Topic	Req	Short name of the measurement, test, or examination described in MITEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MITESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MITESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "HER2", "BRCA1","TTF1".
9	MI	MITEST	Microscopic Examination Name	Char	C132262	Synonym Qualifier	Req	Verbatim name of the test or examination used to obtain the measurement or finding. The value in MITEST cannot be longer than 40 characters. Examples: "Human Epidermal Growth Factor Receptor 2", "Breast Cancer Susceptibility Gene 1", "Thyroid Transcription Factor 1".
10	MI	MITSTDTL	Microscopic Examination Detail	Char	C125922	Record Qualifier	Perm	Further description of the test performed in producing the MI result. This would be used to represent specific attributes, such as intensity score or percentage of cells displaying presence of the biomarker or compound.
11	MI	MICAT	Category for Microscopic Finding	Char		Grouping Qualifier	Perm	Used to define a category of related records.
12	MI	MISCAT	Subcategory for Microscopic Finding	Char		Grouping Qualifier	Perm	Used to define a further categorization of MICAT.
13	MI	MIORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the histopathology measurement or finding as originally received or collected.
14	MI	MIORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Original unit for MIORRES.
15	MI	MISTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	Contains the result value for all findings, copied or derived from MIORRES in a standard format or standard units. MISTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in MISTRESN.
16	MI	MISTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Perm	Used for continuous or numeric results or findings in standard format; copied in numeric format from MISTRESC. MISTRESN should store all numeric test results or findings.
17	MI	MISTRESU	Standard Units	Char	C71620	Variable Qualifier	Perm	Standardized unit used for MISTRESC and MISTRESN.
18	MI	MIRESCAT	Result Category	Char		Variable Qualifier	Perm	Used to categorize the result of a finding. Examples: "MALIGNANT" or "BENIGN" for tumor findings.
19	MI	MISTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate examination not done or result is missing. Should be null if a result exists in MIORRES or have a value of "NOT DONE" when MIORRES = "NULL".
20	MI	MIREASND	Reason Not Done	Char		Record Qualifier	Perm	Reason not done. Used in conjunction with MISTAT when value is NOT DONE. Examples: "SAMPLE AUTOLYZED", "SPECIMEN LOST".
21	MI	MINAM	Laboratory/Vendor Name	Char		Record Qualifier	Perm	Name or identifier of the vendor (e.g., laboratory) that provided the test results.
22	MI	MISPEC	Specimen Material Type	Char	C78734	Record Qualifier	Req	Subject of the observation. Defines the type of specimen used for a measurement. Examples: "TISSUE", "BLOOD", "BONE MARROW".
23	MI	MISPCCND	Specimen Condition	Char	C78733	Record Qualifier	Exp	Free or standardized text describing the condition of the specimen. Example: "AUTOLYZED".
24	MI	MILOC	Specimen Collection Location	Char	C74456	Record Qualifier	Perm	Location relevant to the collection of the specimen. Examples: "LUNG", "KNEE JOINT", "ARM", "THIGH".
25	MI	MILAT	Specimen Laterality within Subject	Char	C99073	Variable Qualifier	Perm	Qualifier for laterality of the location of the specimen in MILOC. Examples: "LEFT", "RIGHT", "BILATERAL".
26	MI	MIDIR	Specimen Directionality within Subject	Char	C99074	Variable Qualifier	Perm	Qualifier for directionality of the location of the specimen in MILOC. Examples: "DORSAL", "PROXIMAL".
27	MI	MIMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	Method of the test or examination. This could include the technique or type of staining used for the slides. Examples: "IHC", "Crystal Violet", "Safranin", "Trypan Blue", or "Propidium Iodide".
28	MI	MILOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.
29	MI	MIBLFL	Baseline Flag	Char	C66742	Record Qualifier	Exp	Indicator used to identify a baseline value. The value should be "Y" or null. Note that MIBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset.
30	MI	MIEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	Role of the person who provided the evaluation. Example: "PATHOLOGIST", "PEER REVIEW", "SPONSOR PATHOLOGIST".
31	MI	VISITNUM	Visit Number	Num		Timing	Exp	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
32	MI	VISIT	Visit Name	Char		Timing	Perm	1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY.
33	MI	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
34	MI	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the Element within the Arm for the element in which the assessment was made.
35	MI	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the date/time at which the specimen was collected.
36	MI	MIDTC	Date/Time of Specimen Collection	Char	ISO 8601	Timing	Exp	Date/time of specimen collection, in ISO 8601 format.
37	MI	MIDY	Study Day of Specimen Collection	Num		Timing	Perm	Study day of specimen collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.