For date fields E2B/M2 has a pair of fields and ARISg has a pair of fields in many cases. Mapping between such fields is done in a single mapping row in the table.
In M2 format, the dates are always exported using a pair of fields
Date format
Date string
Date format has following possible values:
102 - CCYYMMDD
610 - CCYYMM
602 - CCYY
204 - CCYYMMDDHHMMSS
203 – CCYYMMDDHHMM
While importing the pair of fields, the date is interpreted using the associated format. The date is stored in corresponding ARISg DATE field and the field supports precision depending upon the set accordingly.
The possibility of a precise date can occur in the following cases:
Full date
Full date with time
In E2B/M2, every date tag is preceded by a date precision tag.
In ARISg, only imprecise date fields are stored with their precision.
If the precision field is not present for a particular date field, full precision date is assumed. If date precision for a field is lower than the lowest supported by E2B/M2 standard, then that date field is not exported.
If the date precision for a field is higher than the highest supported by E2B/M2 standard, then it is exported with the highest precision supported by E2B/M2 with loss of date precision warnings.
The Logic used while importing the cases are:
Product Reaction Causality Record are created under the following scenario:
If the reaction block contains the following data elements [B.2.i.7.1a, B.2.i.7.1b, B.2.i.7.2a B.2.i.7.2b] and the most suspected drug [That is, the first occurrence of drug block with drugcharacterization is "1"] information,. then a product reaction association record will be created. Latency and Last dose latency will be filled based on the most serious reaction.
If the reaction block does not contain following data elements [B.2.i.7.1a, B.2.i.7.1b, B.2.i.7.2a B.2.i.7.2b] and the most suspected drug [That is, the first occurrence of drug block with drugcharacterization is "1"] information [B.4.k.13.1a,B.4.k.13.1b,B.4.k.13.2a,B.4.k.13.2b,B.4.k.16,B.4.k.17.1] then a product reaction association record will be created. Latency and Last dose latency will be filled based on the available suspected drug.
If the data element B.4.k.17.1 (<drugrecurreadministration> tag ) data value is "1", (Positive) then a product-reaction causality record will be created with the Rechallenge field value set to "Positive" for that particular reaction or event.
Assumption:
The latency and last dose latency information from the most serious reaction will be considered that is, the first reaction that appears in the ICSR. If reaction block latency and last dose latency is not present then it will be considered from drug level.
The product-reaction causality record will not be created in the following scenarios
If drug block and reaction block does not contain any of the causality related data elements.
If the product-reaction causality record is not created for the concomitant drugs.
If relevant <drugreactionasses> tag data is available under <drugreactionrelatedness> entity and the corresponding reaction record is present in reaction entity, record(s) will be created in AER_CAUSALITY table. A record will NOT be created in AER_CAUSALITY table if <drugreactionasses> of causality entity differs from <reactionmeddrallt> under reaction entity.
If the multiple causality information is available for same drug and reaction combination, then in that case, multiple records will be created in AER_CAUSALITY table with the same drug and reaction sequence.
The Product AE Association records for:
All current reactions with suspect/concomitant/ interacting drug combination exported.
All other Product AE Association records (E2B/M2 standard doesn’t support these) will not be exported.
Many of the E2B/M2 numeric fields support a single standard unit. ARISg supports a set of units for the corresponding numeric fields. Hence data in ARISg for these numeric fields should be converted to a standard unit supported by E2B/M2. The converted data is validated against the tag length and precision. E.g. patient weight, patient height. E2B/M2 supports only kg & cm respectively.
If ARISg field unit is higher than the highest corresponding unit supported by E2B, the field is converted to highest unit supported by E2B/M2. If the size exceeds the tag size limit, then the field is not exported, else the field is exported.
If ARISg field unit is smaller than smallest unit supported by E2B/M2, then the field is converted to smallest unit supported by E2B. If the size exceeds tag size, then field will not be exported else the field is exported with warning about loss of precision.
If ARISg field unit is supported by E2B and the size exceeds tag size limit, then the field is converted to a higher unit. If size unit exceeds the prescribed limit, then the field will not be exported, other wise it will be exported with warnings about loss of precision.
For the imported ICSR, the E2B MedDRA coding flag will be considered from the sender of icsr case in the contact maintenance.
If LLT is selected for "E2B MedDRA Coding"
Import module treats the MedDRA tags as LLT codes or decodes. Accordingly the data will be validated and imported into ARIS database.
If tag data contains MedDRA decodes (LLT_TERM) then the corresponding LLT_CODE will be retrieved from MedDRA table (L_LOW_LEVEL_TERM), and the corresponding field populated.
If the tag data contains LLT_CODE then it is directly populated.
If PT is selected for "E2B MedDRA Coding"
Import module treats the MedDRA tags as PT codes or decodes. Accordingly the data will be validated and imported into ARIS database.
If tag data contains MedDRA decodes (PT_TERM) then the corresponding PT_CODE will be queried in MedDRA table (L_PREF_TERM), and the corresponding field will be populated.
If the tag data contains PT_CODE then it is directly populated.
Synchronizing PT/LLT Code & Populating Primary Soc and Case SOC Code (Auto-Coding functionality for all MedDRA tags except <reaction> entity):
if LLT is selected for "E2B MedDRA Coding" the MedDRA tag data will be considered as LLT_CODE/TERM. The PT_CODE is retrieved from the MedDRA dictionary based on the LLT_CODE.
if PT is selected for "E2B MedDRA Coding" the MedDRA tag is considered as PT_CODE/Term. The same code will populate into the LLT_CODE field.
In both the cases, if the corresponding MedDRA version is available, and the same matched with the ARISg Installation parameter, then the PRIMARY_SOC_CODE is retrieved based on the PT_CODE and the same is populated to PRIMARY_SOC_CODE and CASE_SOC_CODE of the appropriate table or else autocoding will not be performed.
NOTE:
For All the above scenarios if the Imported ICSR File contains both MedDRA Term and Version, both will be considered to validate the tag.
If version is missing from the imported ICSR File validation will be done irrespective of the MedDRA Version.
For AutoCoding both MedDRA Term and Version will be considered.
If any of the MedDRA Term or Version is missing in the Imported ICSR File Autocoding of PSOC and CSOC will not be performed
Exceptional Import case(s):
Sender Diagnosis:
If the <senderdiagnosis> tag doesn’t contain the valid MedDRA code/term, the same will be imported into AER. PHARMACOVIGILANCE field.
Test name:
When unit has "MedDRA Coding" selected for testname, system should validate against MedDRA (as per the LLT/PT selection) and populate in MedDRA LLT/PT and tag data will be populated to AER_LAB.TEST_NAME (Field Id: 114502, AER_TEXT Field). If no matching term found, testname text field will be populated.
Similarly when unit has "MedDRA Decoding" selected for testname, system should validate against MedDRA (as per the LLT/PT selection) and populate in MedDRA LLT/PT and tag data will be populated to AER_LAB.TEST_NAME (Field Id: 114502, AER_TEXT Field). If no matching term found, testname text field will be populated.
On the other hand when unit has test name text, system should directly populate the value in target test name text field.
If the <testname> tag contain valid MedDRA code/term and the unit has E2B MedDRA Coding/Decoding and LLT is selected for MedDRA then,
If the tag data is LLT code, the same will be imported to AER_LAB.TEST_NAME_LLT_CODE
If the tag data is LLT Term, then the corresponding LLT Code will be imported to AER_LAB.TEST_NAME_LLT_CODE and the PT_CODE will be retrieved from the MedDRA tables and AER_LAB.PT_CODE field will be populated.
If the <testname> tag contain valid MedDRA code/term and the unit has E2B MedDRA Coding/Decoding and PT is selected for MedDRA then,
If the tag data is PT code, the same will be imported to AER_LAB.PT_CODE
If the tag data is PT Term, then the corresponding PT Code will be imported to AER_LAB. PT_CODE and the LLT_CODE will be retrieved from the MedDRA tables and AER_LAB. TEST_NAME_LLT_CODE field will be populated.
If the <testname> tag contains invalid MedDRA code/ term then,
The tag data will be imported into the AER_LAB.TEST_NAME (Field Id: 114502, AER_TEXT Field).
The tag data will always be imported into the AER_LAB.TEST_NAME (Field Id: 114502, AER_TEXT Field).
For both the above cases, the system will perform auto-coding by populating AER_LAB.PRMARY_SOC_CODE & AER_LAB.CASE_SOC.
NOTE: The AER_LAB.TEST_NAME_MED_VER will NOT be populated since, the <test> entity of the import file doesn’t contain any MedDRA version information.
Auto population of LLT and PT Codes will not be supported if they are custom mapped.
A field, "E2B MedDRA Coding" is available at the ARISg company unit maintenance with options as "LLT (01)" and "PT (02)".
MedDRA terms will be populated in the export file as per the selection made at the company unit level (recipient).
If LLT is selected for 'E2B MedDRA Coding', then the MedDRA LLT will be considered for export.
If PT is selected 'E2B MedDRA Coding' then the MedDRA PT will be considered for export.
If nothing is selected, then LLT will be considered for export.
The system will code the MedDRA fields in the E2B file with the selected attribute for the recipient organization. If nothing is selected, system should default to "LLT". This will be applicable for both export and import.
Exceptional Export case:
While populating <testname> tag,
Company Unit Maintenance in ARISg Administrator does have a field "E2B Test Name Coding" present with the following options:
MedDRA Coding
MedDRA Decoding
Test Name Text
Based on the value selected, system will populate the test name accordingly. If nothing is selected, the test name text will be populated.
If "MedDRA coding" or "MedDRA Decoding" is selected for TestName coding and,
If LLT or blank is selected for "E2B MedDRA Coding" then the MedDRA LLT information will be exported based on the below logic:
If the LLT code (AER_LAB.TEST_NAME_LLT_CODE) field in LAB screen of ARISg contains LLT Code, the same code/decode (based on Testname coding) will be exported.
Otherwise (That is, If AER_LAB.TEST_NAME_LLT_CODE is NULL), if Test name (AER_LAB.TEST_NAME Field Id: 114502, AER_TEXT Field) field contains valid LLT term, the equivalent LLT code/decode (based on Testname coding) will be populated in the <testname> tag.
In both the above scenarios, the B.3.2 <resultstestsprocedures> tag is populated only with the AER.LABORATORY_DESCRIPTION field data.
If the Test Name (AER_LAB.TEST_NAME Field Id: 114502, AER_TEXT Field) field contains invalid LLT term and the LLT code (AER_LAB.TEST_NAME_LLT_CODE) field does not contain a valid LLT code then
The complete <test> block is concatenated with field values and populated in the B.3.2 <resultstestsprocedures> tag.
When the <resultstestsprocedures> tag data exceeds 2000 characters then data is truncated and populated into the tag.
If "MedDRA coding" or "MedDRA Decoding" is selected for TestName coding and,
If PT is selected for "MedDRA" then the MedDRA PT information will be exported based on the below logic:
If the PT code (AER_LAB.PT_CODE) field in LAB screen of ARISg contains valid PT Code, the same code/decode (based on Testname coding) will be exported.
Otherwise (That is, If AER_LAB.PT_CODE is NULL), if Test name (AER_LAB.TEST_NAME Field Id: 114502, AER_TEXT Field) field contains valid PT term, the equivalent PT code/Decode (based on Testname coding) will be populated in the <testname> tag.
In both the above scenarios, the B.3.2 <resultstestsprocedures> tag is populated only with the AER.LABORATORY_DESCRIPTION field data.
If both Test Name (AER_LAB.TEST_NAME Field Id: 114502, AER_TEXT Field) and PT code (AER_LAB.PT_CODE) fields contain invalid PT term then,
The complete <test> block is concatenated with field values and populated in the B.3.2 <resultstestsprocedures> tag.
When the <resultstestsprocedures> tag data exceeds 2000 characters then data is truncated and populated into the tag.
If "Test Name Text" is selected, the test name text will be populated.
By Default if nothing is selected, for TestName coding.
Japanese logic:
testname will be populated From AER_LAB.MHLW_E2B_CODE field.
If AER_LAB.MHLW_E2B_CODE is NULL then testname will be populated From AER_LAB.TEST_NAME (Field Id: 114502, AER_TEXT Field).
English logic:
testname will be populated From AER_LAB.TEST_NAME (Field Id: 114502, AER_TEXT Field).
By Default if nothing is selected for TestName coding, "Test Name Text" is considered.