Ennov InSight Registrations 7.1

Species Indication PDS Attributes

You can use the attributes to describe details for the species indication associated to a PDS.


Attribute	Description
Application Code	Code of the Application to which the PDS is associated.
Application Name	Name of the Application to which the PDS is associated.
Countries	Country (countries) for which this detail is created. The countries available for selection are all countries associated with the Application. The exceptions are application countries with the Withdraw Date value equal to today’s date or earlier. Such countries are not available for selection in the Countries multi-select field on the Add/Modify Indication page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types. If several countries are selected, they are displayed as comma-separated on the View detail page. Defines the value that is included to the XML file during the XEVMPD Submission Wizard execution. Note: By default, all countries associated to the Application appear in the Selected box of the Countries field on the Add Indication page.
Date QC'd	The date the QC Status was set.
Family Code	Code of the Product Family to which the PDS is associated.
Family Name	Name of the Product Family to which the PDS is associated.
Indication	Indication or Indication group. The value is shown as a concatenation of Indication/Intended Use + MedDRA Level + MedDRA Version. Values available for selection are indications that are associated with a Product Family and that do not already exist as a Pending or Approved detail for the related Species detail.
Indication Comments	Any additional information that you want to save with the Indication detail.
Indication Description	Description of the detail.
Indication Keywords	Keywords that you can use in a search for the detail.
Indication Status	Status of the detail. Values available for selection are Pending, Approved, and Not Approved.
Indication Status Date	The date the status of the detail was set.
Product Detail Set Name	PDS to which this detail is associated in the following concatenation delimited by space PDS Name + PDS Code.
Product Name	Full concatenated product name to which the PDS/Template is associated (Product Name + Product Strength + Product Dosage Form +Product Code).
QC Status	QC Status of the detail.
QC'd by	Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed.
Sub-Indication	Sub-indication for the indication. On the Create page, the values available for selection are all sub-indications associated to the selected indication in Data Administration. On the Modify page, the values available for selection are all sub-indications associated to the selected indication in Data Administration, except for those already associated in the PDS.

JavaScript must be enabled in order to use this site.Please enable JavaScript in your browser and refresh the page.

Species Indication PDS Attributes

You can use the attributes to describe details for the species indication associated to a PDS.


Attribute	Description
Application Code	Code of the Application to which the PDS is associated.
Application Name	Name of the Application to which the PDS is associated.
Countries	Country (countries) for which this detail is created. The countries available for selection are all countries associated with the Application. The exceptions are application countries with the Withdraw Date value equal to today’s date or earlier. Such countries are not available for selection in the Countries multi-select field on the Add/Modify Indication page. This is applicable only to applications of Mutual Recognition (MRP) or Decentralised Procedure (DCP) types. If several countries are selected, they are displayed as comma-separated on the View detail page. Defines the value that is included to the XML file during the XEVMPD Submission Wizard execution. Note: By default, all countries associated to the Application appear in the Selected box of the Countries field on the Add Indication page.
Date QC'd	The date the QC Status was set.
Family Code	Code of the Product Family to which the PDS is associated.
Family Name	Name of the Product Family to which the PDS is associated.
Indication	Indication or Indication group. The value is shown as a concatenation of Indication/Intended Use + MedDRA Level + MedDRA Version. Values available for selection are indications that are associated with a Product Family and that do not already exist as a Pending or Approved detail for the related Species detail.
Indication Comments	Any additional information that you want to save with the Indication detail.
Indication Description	Description of the detail.
Indication Keywords	Keywords that you can use in a search for the detail.
Indication Status	Status of the detail. Values available for selection are Pending, Approved, and Not Approved.
Indication Status Date	The date the status of the detail was set.
Product Detail Set Name	PDS to which this detail is associated in the following concatenation delimited by space PDS Name + PDS Code.
Product Name	Full concatenated product name to which the PDS/Template is associated (Product Name + Product Strength + Product Dosage Form +Product Code).
QC Status	QC Status of the detail.
QC'd by	Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed.
Sub-Indication	Sub-indication for the indication. On the Create page, the values available for selection are all sub-indications associated to the selected indication in Data Administration. On the Modify page, the values available for selection are all sub-indications associated to the selected indication in Data Administration, except for those already associated in the PDS.