Microscopic Findings (MI)

mi.xpt, Microscopic Findings — Findings. One record per finding per specimen per subject, Tabulation.

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Variable Name	Variable Label	Type	Controlled Terms, Codelist, or Format	Role	CDISC Notes	Core
STUDYID	Study Identifier	Char		Identifier	Unique identifier for a study.	Req
DOMAIN	Domain Abbreviation	Char	MI	Identifier	Two-character abbreviation for the domain.	Req
USUBJID	Unique Subject Identifier	Char		Identifier	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.	Req
FOCID	Focus of Study-Specific Interest	Char		Identifier	Identification of a focus of study-specific interest on or within a subject or specimen as defined in the protocol for which a measurement, test, or examination was performed. An example could be a drug application site, e.g., "Injection site 1," "Biopsy site 1," "Treated site 1." the value in this variable should have inherent semantic value.	Perm
MISEQ	Sequence Number	Num		Identifier	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
MIGRPID	Group Identifier	Char		Identifier	Used to tie together a block of related records in a single domain for a subject. This is not the dosing group number.	Perm
MIREFID	Specimen Reference Identifier	Char		Identifier	Internal or external specimen identifier. Example: Specimen barcode number.	Perm
MISPID	Mass Identifier	Char		Identifier	Mass identifier such as MASS 1 or MASS A. Used when the mass was discovered during the in-life phase or during pathology and was assigned a mass identifier. The mass identification should be unique within the subject, regardless of mass location.	Perm
MITESTCD	Microscopic Examination Short Name	Char	(MITESTCD)	Topic	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. Extensible controlled value is MIEXAM covering an assessment by microscope (e.g., light, elctron, confocal, etc).	Req
MITEST	Microscopic Examination Name	Char	(MITEST)	Synonym Qualifier	Long name for MITESTCD. The value in MITEST cannot be longer than 40 characters. Extensible controlled value is Microscopic Examination.	Req
MIBODSYS	Body System or Organ Class	Char	(BODSYS)	Record Qualifier	Body system or organ class associated with the specimen examined.	Perm
MIORRES	Result or Findings as Collected	Char		Result Qualifier	Microscopic finding as originally recorded, including all modifiers.	Exp
MISTRESC	Standardized Result in Character Format	Char	(NONNEO) (NEOPLASM)	Result Qualifier	For non-neoplastic findings, contains only the base pathological process (e.g., NECROSIS) without any modifiers such as severity, distribution, chronicity or characteristics. If the examination was completed and there were no findings, the value must be UNREMARKABLE. The base pathological process from MIORRES should be mapped to a synonymous term from the controlled list, NONNEO, where possible. Neoplastic findings must be populated using the NEOPLASM controlled list.	Exp
MIRESCAT	Result Category	Char	(MIRESCAT)	Variable Qualifier	Used to categorize the result of a finding. Example: MALIGNANT for tumor findings or NON-NEOPLASTIC for pathology findings.	Perm
MICHRON	Chronicity of Finding	Char	(CHRNCTY)	Variable Qualifier	Describes the apparent relative duration of a particular finding. Examples: ACUTE, CHRONIC.	Exp
MIDISTR	Distribution Pattern of Finding	Char	(DSTRBN)	Variable Qualifier	Distribution pattern of a particular finding(s) within the examined area. Examples: DIFFUSE, FOCAL, MULTIFOCAL.	Exp
MISTAT	Completion Status	Char	(ND)	Record Qualifier	Used to indicate a test was not done or a test was attempted but did not generate a result. Should be null or have a value of NOT DONE.	Perm
MIREASND	Reason Not Done	Char		Record Qualifier	Describes why MISTAT is NOT DONE, such as SAMPLE AUTOLYZED or SPECIMEN LOST.	Perm
MINAM	Laboratory Name	Char		Record Qualifier	Name or identifier of the laboratory or vendor that provided the test results.	Perm
MISPEC	Specimen Material Type	Char	(SPEC)	Record Qualifier	Defines the type of tissue, orgain, or fluid specimen examined. Examples: LIVER, HEART, BONE MARROW.	Req
MIANTREG	Anatomical Region of Specimen	Char		Variable Qualifier	The protocol-defined subregion of the specimen examined. Example: Cortex or Medulla (if the MISPEC is, for example, GLAND, ADRENAL).	Perm
MISPCCND	Specimen Condition	Char		Record Qualifier	Free or standardized text describing the condition of the specimen. Example: AUTOLYZED.	Exp
MISPCUFL	Specimen Usability for the Test	Char	(NY)	Record Qualifier	Describes the usability of the specimen for the test. Should be "N" if the specimen is not usable; otherwise it should be null.	Exp
MILAT	Specimen Laterality within Subject	Char	(LAT)	Variable Qualifier	Qualifier for laterality of the specimen within the subject for paired specimens. Examples: LEFT, RIGHT, BILATERAL.	Perm
MIDIR	Specimen Directionality within Subject	Char	(DIR)	Variable Qualifier	Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.	Perm
MIMETHOD	Method of Test or Examination	Char		Record Qualifier	Method of the test or examination. This could be different types of staining used for the slides whenever appropriate. Example: H&E.	Perm
MIEVAL	Evaluator	Char		Record Qualifier	Role of the person who provided the evaluation. Examples: TOX PATHOLOGIST, PEER REVIEW.	Perm
MISEV	Severity	Char	(SEV)	Record Qualifier	Describes the severity of a particular finding.	Exp
MIDTHREL	Relationship to Death	Char	(NY)	Record Qualifier	Describes the relationship of a particular finding to the death of a subject ("Y" = caused death, "N" = did not cause death, "U" = unknown). May be left null if not available.	Perm
MIDTC	Date/Time	Char	ISO 8601 datetime or interval	Timing	For a specimen collected or observed post mortem, this is the date/time of subject disposition, in ISO 8601 format.	Perm
MIDY	Study Day	Num		Timing	For a specimen collected or observed post mortem, this is the study day of subject disposition, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.	Perm

Assumptions

Definition:
1. The Microscopic Findings (MI) domain captures the microscopic evaluations/histopathology of the study.
2. This domain should contain at least 1 record for every protocol-scheduled tissue for all subjects in the study (e.g., if an organ was examined and no pathological changes were present, it should have a record indicating "UNREMARKABLE"). Unscheduled tissues that were examined should also have a record. Subjects that were not scheduled for examination should not have records unless they were examined. This assumption supports the creation of incidence tables and statistical analysis on histopathological data.
3. The MI dataset provides a record for each microscopic finding observed throughout the study.
The date/time of the subject disposition in DS is the most relevant date for interpretation of microscopic observations and is used to populate MIDTC.
Specimen definition:
1. The protocol-scheduled organ/tissue for examination is described by up to 5 fields: MISPEC, MIANTREG, MILAT, MIDIR, and FOCID.
2. MISPEC defines the base organ or tissue examined.
3. MIANTREG should be used where applicable and further specifies a part or section of the organ/tissue specified in MISPEC, when that subregion is the targeted area for examination. Examples include the cortex of the kidney, when separated from the kidney medulla, or a study-specific sectioning of the organ (e.g., top section of left liver lobe), but not a case where the liver is examined as a whole, but a specific finding is found for one of the lobes.
4. For a paired organ, the organ used for the specimen should be specified as left, right, or bilateral, using the MILAT variable.
Result definition:
1. In MIORRES, a finding should comprise only 1 base pathological process and its modifiers (e.g., severity, chronicity, distribution, characteristics). However, it is recognized that data may not have been captured in this way; see Section 3.2.2.12, Microscopic Findings (MI), Example 2, for a way to handle this situation.
2. When MIORRES is populated, there must be an entry in MISTRESC. Other relevant components of the MIORRES finding must be parsed into 1 or more of these variables: MISEV, MIDISTR, MICHRON, and the supplemental qualifier MIRESMOD, which are used in combination to standardize the value in MIORRES.
3. MISTRESC: This variable is important for standardizing the value in MIORRES and where possible must use the controlled lists NONNEO and NEOPLASM. If a microscopic finding in a tissue includes 2 related processes, then it can be described by a combination term that has both terms entered, separated by a "/" with no spaces. For example, features of degeneration and regeneration may be observed in a tissue as a continuum of the pathology. The processes can be identified separately or as part of a combined process of degeneration/regeneration. When the process of degeneration/regeneration is used to describe both components, this base process should be recorded in MISTRESC in a single row. The most common combination terms have been included on the NONNEO codelist. Other combination terms that represent 2 related processes can be constructed using preferred terms on the NONNEO codelist, separated by a "/" with no spaces. Terms should not be combined for processes that are unrelated (e.g., NECROSIS and CYST). Unrelated processes should be presented in 2 separate rows.
4. The variables MISTRESC, MIDISTR, and MICHRON use CDISC Controlled Terminology derived from INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice), a collaboration among international societies of toxicological pathologists.
5. The supplemental qualifier MIRESMOD is used to further qualify the finding recorded in MISTRESC. MIRESMOD must be populated if 1 or more modifiers were part of the result in MIORRES and not otherwise reported in the modifier variables part of the MI domain structure (e.g., MISEV, MIDISTR, and MICHRON). In addition to describing observed characteristics of a lesion (e.g., cell type), this variable may be used to identify a specific region affected by the finding within the specimen. For example, when the liver is examined as a whole, but a finding is noted for a specific lobe, this location goes into MIRESMOD. Note that MIANTREG qualifies the excised specimen, whereas MIRESMOD qualifies the particular base pathological process identified within that excised specimen. In general, values for MIRESMOD should be separated by a semicolon unless they only make sense together. An example of an anatomic term is "bile duct"; this cannot be split into "bile" and "duct." An example of a term that should be separated is "centrilobular hepatocytic," which contains 2 terms that stand independently ("centrilobular" and "hepatocytic"). See the SUPPMI examples for further guidance on the use of MIRESMOD.
6. The use of MIRESMOD does not preclude applicants from creating other supplemental qualifiers containing specifically defined modifiers. It is currently expected that MIRESMOD will contain the complete list of modifiers not contained in standard variables (e.g., MISEV, MIDISTR, MICHRON) regardless of their being part of applicant-defined supplemental qualifiers.
7. Tumor findings should have a record in this domain, even if they also have records in the TF domain. It is, however, not required to populate MIRESCAT for tumor findings in the MI domain.
  1. When MIORRES contains a tumor finding the corresponding term from NEOPLASM (CDISC Controlled Terminology list) should be used to populate MISTRESC.
  2. For TF domain: When MISTRESC contains a tumor finding, the corresponding term from the NEOPLASM CT list should be used to populate TFSTRESC. Additional variables populated in the MI domain (e.g., MICHRON, MIDISTR, MIRESMOD) are not populated in the TF domain.
8. Expectations of when MISTAT is "NOT DONE":
  1. If an organ (scheduled for histopathology or introduced later because of adverse findings) for some reason was not examined, the record will have a blank value in MIORRES and MISTAT will be "NOT DONE".
  2. Use of MISTAT and MIREASND: Whenever MISTAT is "NOT DONE", MIREASND should provide the reason for not completing the evaluation as described in the study plan.
9. For microscopic evaluations that have numeric results (e.g., specific cell count tests), MISTRESN and MISTRESU should be included, as well as other applicable variables for the Findings observation class to reflect the data accurately.
The MISPID variable is intended to reflect the mass identification. This variable should be used to link in-life findings (e.g., mass identification) with pathology findings. The mass identifier in --SPID should be consistent across domains (Clinical Observations, Palpable Masses, Macroscopic Findings, MI, and TF).
The value in FOCID should have semantic value; that is, although "1" is not considered adequate, "Injection site 1" is acceptable.

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Microscopic Findings (MI)