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

1. 010 · ST · Transaction Set Header · Max 1 · Mandatory

   To indicate the start of a transaction set and to assign a control number

2. 020 · BGN · Beginning Segment · Max 1 · Mandatory

   To indicate the beginning of a transaction set

3. 030 · STP · Study Parameters · Max 1 · Mandatory

   To report study parameters

4. N1 Loop Mandatory Repeat >1

   1. 040 · N1 · Name · Max 1 · Mandatory

      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. 050 · N2 · Additional Name Information · Max 2 · Optional

      To specify additional names or those longer than 35 characters in length

   3. 060 · N3 · Address Information · Max 2 · Optional

      To specify the location of the named party

   4. 070 · N4 · Geographic Location · Max 1 · Optional

      To specify the geographic place of the named party

   5. 080 · G61 · Contact · Max 1 · Optional

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

Detail

1. GID Loop Mandatory Repeat >1

   1. 010 · GID · Group Identification · Max 1 · Mandatory

      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. 020 · GRP · Group Dosage Parameters · Max 1 · Mandatory

      To report group-specific variables on dosages

   3. 030 · MSG · Message Text · Max >1 · Mandatory

      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. 040 · GDP · General Dosing Parameters · Max >1 · Mandatory

      Reports dosing parameters for a group of animals or an individual animal

   5. 050 · REF · Reference Identification · Max >1 · Mandatory

      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. 060 · N1 · Name · Max 1 · Mandatory

         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. 070 · N2 · Additional Name Information · Max 2 · Optional

         To specify additional names or those longer than 35 characters in length

      3. 080 · N3 · Address Information · Max 2 · Optional

         To specify the location of the named party

      4. 090 · N4 · Geographic Location · Max 1 · Optional

         To specify the geographic place of the named party

   7. ANI Loop Mandatory Repeat >1

      1. 100 · ANI · Animal Identification · Max 1 · Mandatory

         To uniquely identify each animal within the group

         The Animal (ANI) loop reports individual animal information.

      2. 110 · ARC · Animal Results Counts · Max >1 · Mandatory

         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. 120 · GDP · General Dosing Parameters · Max >1 · Optional

         Reports dosing parameters for a group of animals or an individual animal

      4. 130 · ADI · Animal Disposition · Max 1 · Optional

         To record the disposition of an individual animal

      5. 140 · ATR · Animal Test Result · Max >1 · Optional

         To report individual animal test results

      6. AOL Loop Optional Repeat >1

         1. 150 · AOL · Animal Observation Location · Max 1 · Mandatory

            To report the location of a specific observation

            The Animal Observation Location (AOL) loop indicates the location of an observation result.

         2. 160 · MSG · Message Text · Max >1 · Optional

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

         3. AOR Loop Optional Repeat >1

            1. 170 · AOR · Animal Observation Result · Max 1 · Mandatory

               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. 180 · NTE · Note/Special Instruction · Max >1 · Mandatory

               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. 190 · MSG · Message Text · Max >1 · Optional

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

      7. AST Loop Optional Repeat >1

         1. 200 · AST · Animal Reproductive Status · Max 1 · Mandatory

            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. 210 · ADT · Animal Parturition Status · Max 1 · Optional

            Report the parturition status for the parent animal

         3. 220 · AOC · Animal Offspring Counts · Max >1 · Optional

            To report offspring counts for the parent animal

      8. AOI Loop Optional Repeat >1

         1. 230 · AOI · Animal Offspring/Fetus Identification · Max 1 · Mandatory

            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. 240 · ATR · Animal Test Result · Max >1 · Optional

            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. 250 · AOL · Animal Observation Location · Max 1 · Mandatory

               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. 260 · MSG · Message Text · Max >1 · Optional

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

            3. AOR Loop Optional Repeat >1

               1. 270 · AOR · Animal Observation Result · Max 1 · Mandatory

                  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. 280 · NTE · Note/Special Instruction · Max >1 · Mandatory

                  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. 290 · MSG · Message Text · Max >1 · Optional

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

2. 300 · SE · Transaction Set Trailer · Max 1 · Mandatory

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