You are viewing an old version of this page. View the current version.

Compare with Current View Page History

Version 1 Next »

  1. 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).
  2. 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").
  3. 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.
  4. 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.
  5. 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.
  6. 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).
  7. Macroscopic findings commonly correlate to clinical findings and microscopic findings. Establishing this relationship may be accomplished by using the RELREC table (see Section 8.2, Relating Records - RELREC).

  • No labels