Database Columns Added: Ennov InSight 7.3
The following Database columns were added in this release.
|
UI Field Name |
Database Table Name |
Database Column Name |
Databas e Column Type and Size |
Description |
| N/A | N/A | N/A | N/A |
REGULATORY_ENTITLEMENT_STA TUS _TYPE is updated to display data from Data Administration > Regulatory Entitlement Status DA list |
| Device Descriptio n | MGR.PDS_MED_DEVICE _CHANGE | DEVICE_DESCR IPTION |
VARCHA R2(4000 ) |
To conform to the latest IDMP specification released, the new DEVICE_DESCRIPTION сolumn is added to the MGR.PDS_MED_DEVICE_CHANGE table. |
|
Device Descriptio n of Intended Purpose |
MGR.PDS_MED_DEVICE _CHANGE | DEVICE_INTEN DED_USE |
VARCHA R2(4000 ) |
To conform to the latest IDMP specification released, the new DEVICE_INTENDED_USE сolumn is added to the MGR.PDS_MED_DEVICE_CHANGE table. |
| Device Descriptio n Language | MGR.PDS_MED_DEVICE _CHANGE | DEVICE_LANG UAGE_TYPE_ID | NUMBER |
To conform to the latest IDMP specification released, the new DEVICE_LANGUAGE_TYPE_ID сolumn is added to the MGR.PDS_MED_DEVICE_CHANGE table. |
|
Device Classificat ion |
MGR.PDS_MED_DEVICE _CHANGE | DEVICE_CLASS _TYPE_ID | NUMBER |
To conform to the latest IDMP specification released, the new DEVICE_CLASS_TYPE_ID сolumn is added to the MGR.PDS_MED_DEVICE_CHANGE table. |
| N/A | N/A | CODE |
VARCHA R2(100) |
MGR.EVENT_PLAN_COUNTRY |
|
UI Field Name |
Database Table Name |
Database Column Name |
Databas e Column Type and Size |
Description |
|
Manufactu red Item Quantity Operator |
MGR.MANUFACTURED_ ITEM |
QUANTITY_ME ASURE_TYPE_I D |
NUMBER |
To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the new QUANTITY_MEASURE_TYPE_ID is added to the MGR.MANUFACTURED_ITEM table. |
|
Package Item Container Quantity |
MGR.PDS_PACKSET_DE TAIL_CHANGE |
PI_CONTAINER _QUANTITY_M EASURE_TYPE_ ID |
NUMBER |
To conform to the latest IDMP specification released, the new PI_CONTAINER_QUANTITY_MEAS URE_TYPE_ID сolumn is added to the MGR.PDS_MED_DEVICE_CHANGE table.MGR. |
|
Package Item - MI Quantity Operator |
MGR.PDS_PACKSET_DE TAIL_CHANGE |
MI_QUANTITY_ MEASURE_TYP E_ID |
NUMBER |
To conform to the latest IDMP specification released, the new MI_QUANTITY_MEASURE_TYPE_I D сolumn is added to the MGR.PDS_PACKSET_DETAIL_CHA NGE table. |
|
Device Quantity Operator |
MGR.PDS_PACKSET_DE TAIL_CHANGE |
PDS_MED_DEV ICE_QTY_MEAS URE_TYPE_ID |
NUMBER |
To conform to the latest IDMP specification released, the new PDS_MED_DEVICE_QTY_MEASURE _TYPE_ID сolumn is added to the MGR.PDS_PACKSET_DETAIL_CHA NGE table. |
|
Pack Size Quantity Operator |
MGR.PDS_PACKSIZE |
QUANTITY_ME ASURE_TYPE_I D |
NUMBER |
To conform to the latest IDMP specification released, the new QUANTITY_MEASURE_TYPE_ID сolumn is added to the MGR.PDS_PACKSIZE table. |
|
UI Field Name |
Database Table Name |
Database Column Name |
Databas e Column Type and Size |
Description |
|
Pack Size Quantity Operator |
MGR.PDS_PACKSIZE_C HANGE |
QUANTITY_ME ASURE_TYPE_I D |
NUMBER |
To conform to the latest IDMP specification released, the new QUANTITY_MEASURE_TYPE_ID сolumn is added to the MGR.PDS_PACKSIZE_CHANGE table. |
|
Attachme nt Document Status |
MGR.ACTION_ATTACH MENT |
ATTACHED_DO CUMENT_STAT US_TYPE_ID |
NUMBER |
To conform to the latest IDMP specification released, the new ATTACHED_DOCUMENT_STATUS_ TYPE_ID сolumn is added to the MGR.ACTION_ATTACHMENT table. |
|
Attached Document URL |
MGR.ACTION_ATTACH MENT | URL |
VARCHA R2(4000 ) |
To conform to the latest IDMP specification released, the new URL сolumn is added to the MGR.ACTION_ATTACHMENT table. |
|
Sequence Standard Type |
MGR.SEQUENCE | CTD_TYPE_ID | NUMBER |
To conform to the new eCTD 4.0 requirements, the new CTD_TYPE_ID column is added to the MGR.SEQUENCE table. |
| UUID | MGR.SEQUENCE | UUID |
VARCHA R2(50) |
To conform to the new eCTD 4.0 requirements, the new UUID column is added to the MGR.SEQUENCE table. |
|
Senderdefined Keywords Codesyste m |
MGR.APPLICATION |
CODESYSTEM_ FOR_SDKEYWO RDS |
VARCHA R2(200) |
To conform to the new eCTD 4.0 requirements, the new CODESYSTEM column is added to the MGR.APPLICATION table. |
| UUID | MGR.APPLICANT_CONT ACT | UUID |
VARCHA R2(100) |
To conform to the new eCTD 4.0 requirements, the new CODESYSTEM column is added to the MGR.APPLICANT_CONTACT table. |
|
UI Field Name |
Database Table Name |
Database Column Name |
Databas e Column Type and Size |
Description |
| Prefix | MGR.APPLICANT_CONT ACT | PREFIX |
VARCHA R2(20) |
To conform to the new eCTD 4.0 requirements, the new PREFIX column is added to the MGR.APPLICANT_CONTACT table. |
|
First Name |
MGR.APPLICANT_CONT ACT | FIRST_NAME |
VARCHA R2(200) |
To conform to the new eCTD 4.0 requirements, the new PREFIX column is added to the MGR.APPLICANT_CONTACT table. |
|
Middle Name |
MGR.APPLICANT_CONT ACT | MIDDLE_NAME |
VARCHA R2(200) |
To conform to the new eCTD 4.0 requirements, the new PREFIX column is added to the MGR.APPLICANT_CONTACT table. |
| Last Name | MGR.APPLICANT_CONT ACT | LAST_NAME |
VARCHA R2(200) |
To conform to the new eCTD 4.0 requirements, the new LAST_NAME column is added to the MGR.APPLICANT_CONTACT table. |
| Suffix | MGR.APPLICANT_CONT ACT | SUFFIX | Varchar 2(20) |
To conform to the new eCTD 4.0 requirements, the new SUFFIX column is added to the MGR.APPLICANT_CONTACT table. |
| Initials | MGR.APPLICANT_CONT ACT | INITIALS | Varchar 2(20) |
To conform to the new eCTD 4.0 requirements, the new INITIALS column is added to the MGR.APPLICANT_CONTACT table. |
| Delimiter | MGR.APPLICANT_CONT ACT | DELIMITER | Varchar 2(10) |
To conform to the new eCTD 4.0 requirements, the new DELIMITER column is added to the MGR.APPLICANT_CONTACT table. |
|
Represent ed Company Name |
MGR.APPLICANT_CONT ACT | COMPANY_NA ME |
VARCHA R2(200) |
To conform to the new eCTD 4.0 requirements, the new COMPANY_NAME column is added to the MGR.APPLICANT_CONTACT table. |
|
UI Field Name |
Database Table Name |
Database Column Name |
Databas e Column Type and Size |
Description |
|
eCTD Standard Type |
MGR.APPLICANT_CONT ACT_TYPE | CTD_TYPE_ID | NUMBER |
To conform to the new eCTD 4.0 requirements, the new CTD_TYPE_ID column is added to the MGR.APPLICANT_CONTACT_TYPE table. |
| Associate d Entity ID | ODS.EXTRA_FIELDS_IP | ASSOCIATED_E NTITY_ID | NUMBER |
To conform to the new eCTD 4.0 requirements, the new ASSOCIATED_ENTITY_ID column is added to the ODS.EXTRA_FIELDS_IP table. |
|
eCTD Standard Type |
ODS.ASSEMBLY | CTD_TYPE_ID | NUMBER |
To conform to the new eCTD 4.0 requirements, the new CTD_TYPE_ID column is added to the ODS.ASSEMBLY table. |
| N/A | ODS.FOLDER | CV_NODE_ID | NUMBER |
To conform to the new eCTD 4.0 requirements, the new CV_NODE_ID column is added to the ODS.FOLDER table. |
|
Priority Number |
ODS.LEAF | LEAF_PRIORIT Y_NO | NUMBER | To conform to the new eCTD 4.0 requirements, the new LEAF_PRIORITY_NO column is added to the ODS.LEAF table. |
| Document ID | ODS.LEAF | LEAF_PUB_DOC _UUID |
VARCHA R2(100) |
To conform to the new eCTD 4.0 requirements, the new LEAF_PUB_DOC_UUID column is added to the ODS.LEAF table. |