General ICSR Extensibility

For ICSR reports where the customization is limited to changes in the mapping logic or in the HL7 representation logic, follow the next steps:

1. Copy the standard profile based on the business need. The copied profile will be available on CFG_PROFILE. The profile can be extended as follows:
   1. Navigate to Console > System Configuration > Interchange Mapping > Manage Profile.
   2. Select a Profile from the drop-down list.
      For example, ICH-ICSR V3.0 MESSAGE TEMPLATE- EMA.
   3. Click the Copy button.
   4. Enter the Extension Profile name.
   5. Click the Save button, and OK.
   6. Select the newly created profile from the drop-down list.
   7. Click to modify or review the existing mapping query for required elements.
   The copied profile will be available on CFG_PROFILE. Review the field values and updated fields.

   Field	Description
   PROFILE	Name of the profile as entered.
   PROFILE_VERSION	Version of DTD as specified in the ICH document. Oracle recommends to keep as populated by the UI.
   PROFILE_TYPE	Type of Profile. The options are MSG_TEMPLATE and ACK_TEMPLATE. If a user copies a profile containing MSG_TEMPLATE or ACK_TEMPLATE, the value will be set to ACK_DEFINED or MSG_DEFINED. Oracle recommends to keep the value as populated by UI.
   PROFILE_RELEASE	Release version of the DTD as specified in the ICH document. Oracle recommends to keep as populated by UI.
   PROFILE_DTD	File name of the Message DTD / XSD used to validate a message. If the file is modified then the same name has to be updated and made available in the appropriate location under the installation path.
   PROFILE_ACTIVE	Indication of which profile is active.
   ROOT_ELEMENT	Top element of the profile. Oracle recommends to keep as populated by UI.
   AUTHORITY_ID	Identifier for the Regulatory Authority Profile (EMEA, FDA, MHLW, and ICH) and foreign key to CFG_AUTHORITY.AUTHORITY_ID. Oracle recommends to keep as populated by UI.
   PROFILE_LENGTH_CHECK	Indication that the profile was to check the length of each DTD element. Value 1 => Should be used and 0 => Should not be used. Not applicable for profiles with APPLY_CONF_RULE = 1.
   IMPORT_POST_SAVE	Flag used after E2b import to run the POST SAVE Procedure. Applicable only if the profile is supported for import. If the value is 1, the POST SAVE procedure is executed.
   EXTENSION	Value 1 in this column indicates that this profile is used for E2B extensions. Extended profiles must have the value 1.
   UPDATE_BEFORE_TRANS	Value 1 indicates that the transmission date and the message date are updated in an ICHICSR message before the message is transmitted. 0 represents the opposite.
   HL7_PROFILE	Identifier for the HL7 profile type.
   CREATE_REPOSITORY	Value 1 populates the ESM staging tables. Value 0 does not populate the tables.
   REPORT_FORM	Report form supported by the Profile.
   APPLY_CONF_RULE	Flag that determines whether the conformance rule applies or not.

2. To modify the mapping query:
   1. Navigate to the customized profile using Console > System Configuration > Interchange Mapping > Manage Profile.
   2. Based on whether the mapping is provided at the level of the element itself or its parent, modify the mapping query of the respective element.
   3. Verify the mapping for correctness.
      The modified query can be saved from Manage Profile or can be updated to CFG_MAPPING_SQLS field using the upgrade script. The upgrade script should be element and profile specific.

      Note:

      In the case of R2, if the element has to be updated in the nullification report as well, then CFG_E2B. UPDATE_FOR_NULLIFICATION should be set to 1 and CFG_E2B. CHILD_ONLY_SQL should be populated with the mapping query that is specific to that particular element. In the same scenario, if the element has the mapping logic at the element level (i.e., CFG_E2B.AE_SELECT_STMT), the population of CFG_E2B. CHILD_ONLY_SQL is not required.
3. Modifying HL7 reports applies only to R3 / HL7 based reports (ICH & PMDA E2BR3, eVAERS and eMDR). Oracle recommends that you modify the respective XSLT templates based on the business need. To modify HL7 reports, follow the next steps:
   1. Back up the existing templates.
   2. Modify the templates based on the element added in the respective parent node.
   3. Navigate to the desired XSLT template and modify the XSLT as per the HL7representation provided.
      For Null Flavor support, refer the other sections of this document.
   4. If the new templates address a specific requirement, specify the mode so that the templates are uniquely identified across the reports.
   5. If any new variable is specific to a report, verify that the respective variable is uniquely named.
   6. Replace the modified XSLTs on all the servers (Web Server, AG Server & Interchange Server).