EDI 249 Animal Toxicological Data

Functional Group AT

X12M Supply Chain Subcommittee

This Draft Standard for Trial Use contains the format and establishes the data contents of the Animal Toxicological Data Transaction Set (249) for use within the context of an Electronic Data Interchange (EDI) environment. The transaction set can be used to exchange animal toxicology data collected from studies conducted on pesticides, drugs, or other substances. This transaction set accommodates the lowest reportable level of individual animal toxicology data for transfer between industry and the government, within industry itself, and between government agencies. The transaction set will enable the exchange of both definitive end points or in-life study data, as well as observational or opinion type data.

Heading

Position
Segment
Name
Max use
  1. To indicate the start of a transaction set and to assign a control number

  2. To indicate the beginning of a transaction set

  3. To report study parameters

  4. N1 Loop Mandatory
    Repeat >1
    1. To identify a party by type of organization, name, and code

      The N1 loop designates the study originator(s) or participating laboratory, study submitter(s) and author(s). The primary contact shall be listed in each case.
    2. To specify additional names or those longer than 35 characters in length

    3. To specify the location of the named party

    4. To specify the geographic place of the named party

    5. To identify a person or office to whom communications should be directed

Detail

Position
Segment
Name
Max use
  1. GID Loop Mandatory
    Repeat >1
    1. To identify each dose group name and dose group gender

      The Group Identification (GID) loop reports the study group information. Each unique combination of dose level and gender is defined as a separate group.
    2. To report group-specific variables on dosages

    3. To provide a free-form format that allows the transmission of text information

      One or more Message Text (MSG) segment(s) identifies the test substance/compound name.
    4. Reports dosing parameters for a group of animals or an individual animal

    5. To specify identifying information

      The REF segment is used to specify both the animal species and the strain of animals used within this group on this study.
    6. N1 Loop Mandatory
      Repeat >1
      1. To identify a party by type of organization, name, and code

        The N1 loop reports the names and addresses associated with the animal source supplier.
      2. To specify additional names or those longer than 35 characters in length

      3. To specify the location of the named party

      4. To specify the geographic place of the named party

    7. ANI Loop Mandatory
      Repeat >1
      1. To uniquely identify each animal within the group

        The Animal (ANI) loop reports individual animal information.
      2. To record the number of results reported for each test or observation type

        One or more Animal Results Counts (ARC) segment(s) report the count of each type of result for this animal.
      3. Reports dosing parameters for a group of animals or an individual animal

      4. To record the disposition of an individual animal

      5. To report individual animal test results

      6. AOL Loop Optional
        Repeat >1
        1. To report the location of a specific observation

          The Animal Observation Location (AOL) loop indicates the location of an observation result.
        2. To provide a free-form format that allows the transmission of text information

        3. AOR Loop Optional
          Repeat >1
          1. To report observation results at the specified location

            The Animal Observation Result (AOR) loop reports an observation type result for the specified location and individual animal.
          2. To transmit information in a free-form format, if necessary, for comment or special instruction

            One or more Note/Special Instruction (NTE) segment(s) describe the observed change in the animal observation location.
          3. To provide a free-form format that allows the transmission of text information

      7. AST Loop Optional
        Repeat >1
        1. To report reproductive status for the parent animal

          The Animal Reproductive Status (AST) loop specifies individual reproductive status and counts of offspring/fetal data.
        2. Report the parturition status for the parent animal

        3. To report offspring counts for the parent animal

      8. AOI Loop Optional
        Repeat >1
        1. To identify offspring/fetuses of the parent animal

          The Animal Offspring Identification (AOI) loop uniquely identifies each offspring/fetus for the individual animal specified.
        2. To report individual animal test results

          The Animal Test Results (ATR) segment reports reproductive/developmental test results for the individual offspring specified.
        3. AOL Loop Optional
          Repeat >1
          1. To report the location of a specific observation

            The Animal Observation Location (AOL) loop indicates the location of an observation result for a reproductive/developmental study.
          2. To provide a free-form format that allows the transmission of text information

          3. AOR Loop Optional
            Repeat >1
            1. To report observation results at the specified location

              The Animal Observation Results (AOR) loop reports an observation type result for the specified location and individual offspring on a reproductive/developmental study.
            2. To transmit information in a free-form format, if necessary, for comment or special instruction

              One or more Note/Special Instruction (NTE) segment(s) describe the observed change in the offspring observation location.
            3. To provide a free-form format that allows the transmission of text information

  2. To indicate the end of the transaction set and provide the count of the transmitted segments (including the beginning (ST) and ending (SE) segments)

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