SEND Macroscopic Findings (MA)

ma.xpt, Macroscopic 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	MA	Identifier	Two-character code 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
MASEQ	Sequence Number	Num		Identifier	Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.	Req
MAGRPID	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
MAREFID	Specimen Reference Identifier	Char		Identifier	Internal or external specimen identifier. Example: 1009570101.	Perm
MASPID	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
MATESTCD	Macroscopic Examination Short Name	Char	(MATESTCD)	Topic	Short name of the measurement, test, or examination described in MATEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in MATESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). MATESTCD cannot contain characters other than letters, numbers, or underscores.	Req
MATEST	Macroscopic Examination Name	Char	(MATEST)	Synonym Qualifier	Long name for MATESTCD. The value in MATEST cannot be longer than 40 characters. Extensible controlled values are Gross Pathological Examination, Clinical Signs Follow-up.	Req
MABODSYS	Body System or Organ Class	Char	(BODSYS)	Record Qualifier	Body system or organ class associated with the specimen examined.	Perm
MAORRES	Result or Findings as Collected	Char		Result Qualifier	Text description of the findings as originally received or collected, including the base gross pathological observation and any modifiers, such as severity, origin, classification, size, color, etc.	Exp
MASTRESC	Standardized Result in Character Format	Char		Result Qualifier	Contains only the base gross pathological observation (e.g., ENLARGED) from MAORRES, without any modifiers. If the examination was completed and there were no findings, the value must be UNREMARKABLE.	Exp
MASTAT	Completion Status	Char	(ND)	Record Qualifier	Used to indicate examination not done or result is missing. Should be null if a result exists in MAORRES.	Perm
MAREASND	Reason Not Done	Char		Record Qualifier	Describes why MASTAT is NOT DONE. Example: Tissue not examined, Tissue Autolyzed.	Perm
MANAM	Laboratory Name	Char		Record Qualifier	Name or identifier of the laboratory or vendor that provided the test results.	Perm
MASPEC	Specimen Material Type	Char	(SPEC)	Record Qualifier	Defines the type of tissue, organ, or fluid examined. Examples: GLAND, ADRENAL; KIDNEY; VESSEL, LYMPHATIC. See also Assumption 4.b.	Exp
MAANTREG	Anatomical Region of Specimen	Char		Variable Qualifier	Defines the specific anatomical or biological region of a tissue, organ specimen, or the region from which the specimen was obtained, such as a section or part of what is defined in the MASPEC variable. If the anatomical region is not included in the specimen description MASPEC, it may be included in this variable. This field can be a combination of terms where needed. This field can be null if not applicable. Examples: CORTEX, MEDULLA, MUCOSA, SEROSA, ISLET, ZONA FASICULATA, ZONA RETICULARIS, CRANIAL, MEDIAN, ACCESSORY, SPINAL, LUMBAR, FRONTAL.	Perm
MASPCCND	Specimen Condition	Char		Record Qualifier	Free or standardized text describing the condition of the specimen. Example: AUTOLYZED.	Perm
MASPCUFL	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.	Perm
MALAT	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
MADIR	Specimen Directionality within Subject	Char	(DIR)	Variable Qualifier	Qualifier for directionality of the specimen within the subject. Examples: DORSAL, PROXIMAL.	Perm
MAPORTOT	Portion or Totality	Char	(PORTOT)	Variable Qualifier	Qualifier for anatomical location or specimen further detailing the portion or totality, which means arrangement of, or apportioning of. Examples: ENTIRE, SINGLE, SEGMENT, MANY.	Perm
MAEVAL	Evaluator	Char		Record Qualifier	Role of the person who provided the evaluation. Used only for results that are subjective (i.e., assigned by a person or a group). Examples: PRINCIPAL PATHOLOGIST, PEER REVIEW, Applicant PATHOLOGIST.	Perm
MASEV	Severity	Char	(SEV)	Record Qualifier	Describes the severity or intensity of a particular finding. Examples: MILD, MODERATE, SEVERE.	Perm
MADTHREL	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
MADTC	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
MADY	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 Macroscopic Findings (MA) dataset provides a record for each macroscopic finding observed.
2. Every subject examined at necropsy should have at least 1 record in the MA domain (e.g., the record could be NORMAL (in MAORRES) for MASPEC value of "ALL TISSUES", implying all protocol-required tissues).
MATESTCD and MATEST are either GROSPATH and gross pathological examination or CLSFUP and clinical signs follow-up.
1. In most cases, MATESTCD and MATEST will be GROSPATH and gross pathological examination.
2. As part of the necropsy review, a follow-up examination may be performed on clinical signs to verify existence at necropsy (present/not present) and to correlate them to gross pathological examinations. To record these in the MA domain, the result should be represented as the text result of the examination (e.g., "SKIN LESION NOT FOUND AT NECROPSY").
The date/time of the subject disposition (in DS) is the most relevant date for interpretation of macroscopic observations and is used to populate MADTC.
Organ/tissue definition:
1. The subject organ/tissue of examination is described by up to 5 fields: MASPEC, MAANTREG, MALAT, MADIR, and MAPORTOT.
2. MASPEC defines the base organ or tissue examined and is required when MATEST is "Gross Pathological Examination." It should not be used when MATEST is "Clinical Signs Follow-up". The value is singular in cases of multilateral organs when the MALAT or MADIR fields can be used to describe laterality and/or position.
3. MAANTREG should be used where applicable, and further specifies a part or section of the organ/tissue specified in MASPEC. Examples include the cortex of the kidney or a study-specific sectioning of the organ (e.g., top section of left liver lobe).
4. Specify laterality and/or position for those organs that can exist in multiple locations: Use "SINGLE" for MAPORTOT for cases where 1 of the multilateral organs is examined, but which one was used is unknown. Use "BILATERAL" for MALAT for cases where the finding was recorded on the paired organs of a bilateral pair.
5. For bilateral organs, records may be included for the left, right, and/or both left and right organs.
Result definition:
1. When the results of all tissues are normal, the special value of "ALL TISSUES" may be used in MASPEC, with a single record whose value in MAORRES is NORMAL and in MASTRESC is UNREMARKABLE, without individually listing each tissue.
2. MASTRESC: This variable is important for standardizing the value in MAORRES.
  1. Modifiers of the base gross pathological observation (in MASTRESC) should be included within supplemental qualifiers (see SUPPMA Example 1):
  2. QNAM = "--RESMOD"
  3. QLABEL = "Result Modifiers"
  4. QVAL = concatenated modifiers of the base gross pathological process, separated by semicolons
  5. If a severity was received or collected, MASEV must be populated.
MASPID variable is intended to reflect the mass identification. This variable should be used to link in-life findings with pathology findings. The mass identifier in --SPID should be consistent across domains (Clinical Observations, Palpable Masses, MA, Microscopic Findings, and Tumor Findings).
Macroscopic findings commonly correlate to clinical findings and microscopic findings. Establishing this relationship may be accomplished by using the RELREC table.

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SEND Macroscopic Findings (MA)