Data Administration Tables Updated: Calyx RIM 7.0

The following Data Administration tables, sections, or fields are updated in Calyx RIM 7.0 release.

Data Administration Section: Application Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Chief Investigator Values	N/A	N/A	The Chief Investigator Values table is hidden by default in the Data Administration > Application Maintenance section.
Sponsor Type Values	N/A	N/A	The Sponsor Type Values Sponsor Type Values table is hidden by default in the Data Administration > Application Maintenance section.
Application Status Values	Application	System Process Default Flag	When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default Flag is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.
Age Span Population Values Application Category Values Application Status Values Application Type Values Country Values CTA Product Role Values Legal Status Values MedDRA Term Values Medical Condition Investigated Values Procedure Type Values Reason for Premature Ending Values Region Values Region Type Values Trial Design Values Trial Phase Values Trial Scope Values Trial Subject Group Values	Application	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Assembly Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Assembly Category	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Assembly DTD/Schema Type
Assembly Status
Assembly Subcategory

Data Administration Section: Change Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Change Type Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Event-Change-Detail Status Values	Event
Event-Change-Detail Status Values	Event	System Process Default Flag	When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default Flag is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.

Data Administration Section: Custom Lists Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Custom List Names Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Custom List Values

Data Administration Section: DMS Integration

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Bind to Label Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Bind to Status Values
Rendition Identifier Values

Data Administration Section: Event Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Action Type Values EU Grouping or Worksharing Values Event Status Values Event Type Values PSUR Report Code Values Secondary Event Type Values Timeline/Event Plan Type Values Timeline/Event Plan Values	Event	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Notifications

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Notification Specifications Values Notifications Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Other

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Concentration Measure Type Values Denominator Unit Values Entity XML/UI Mappings Values Home Page Display Properties Values Indications/Intended Use Values Language Values Legal Basis Values Length Unit Of Measure Values MAH/Development Sponsor/Organisation Values Master File Location (MFL) Values Message Sender Values Numerator Unit Values Previous EV Code Values Quantity Unit Of Measure Values Reason for E-Signature Values Reason for Termination/Withdrawal Values SME Status Values Sub-Indication Values System Alert Type Values Unit of Measure Prefix Values Unit of Presentation Values Weight Unit of Measure Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Numerator Unit Values	N/A	N/A	The RMS Term Name field in the initial table view now appears as a column in the grid view.

Data Administration Section: Product Detail Set Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Genetically Modified Cell Origin Species Values	N/A	N/A	The Genetically Modified Cell Origin Species Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Product Bio Type Values	N/A	N/A	The Product Bio Type Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Somatic Cell Therapy Cell Types Values	N/A	N/A	The Somatic Cell Therapy Cell Types Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Somatic Cell Therapy Origin Species Values	N/A	N/A	The Somatic Cell Therapy Origin Species Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Somatic Cell Therapy Origins Values	N/A	N/A	The Somatic Cell Therapy Origins Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Source of Scientific Advice Values	N/A	N/A	The Source of Scientific Advice Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Type of Dossier Submitted Values	N/A	N/A	The Type of Dossier Submitted Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Type of Gene Therapy Transfer Product Values	N/A	N/A	The Type of Gene Therapy Transfer Product Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Type of Gene Therapy Values	N/A	N/A	The Type of Gene Therapy Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Type of Genetically Modified Cell Origin Values	N/A	N/A	The Type of Genetically Modified Cell Origin Values table is hidden by default in the Data Administration > Product Detail Set Maintenance section.
Product Detail Set Maintenance	Product	System Process Default Flag	When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default Flag is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.
Color Values Compendial Designation/Source Values Dose Frequency Values Human Consumption Product Values Label Type Values Manufacturer Values Manufacturing Functions Values Material Type Values Material Values Medical Device Part Code Values Packaging Category Values Product Detail Set Status Values Product Material Values Production Type Values QC Status Values Shape Values Shelf Life Category Values Shelf Life Type Values Species Values Storage Condition Values Substance Role Values Substance Type Values Time Unit Values Volume Unit of Measure Values	Product	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Product Family Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
ATC Values Division Values Product Family Status Values Product Family Values Substance Class Values Substance Values Therapeutic Area Values Therapeutic Class Values Trade Name Values	N/A	N/A	The RMS Term Name field in the initial table view now appears as a column in the grid view.
	Product Family	Product Family Status Product Family Status Date Development Sponsor	The Product Family Status , Product Family Status Date , Development Sponsor fields are hidden by default in Data Administration > Product Family Values section.
	Product Family	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Product Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Dosage/Pharmaceutical Form Values	N/A	N/A	The RMS Term Name field in the initial table view now appears as a column in the grid view.
Product Status Values	Product	System Process Default Flag	When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default Flag is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.
Applicable Standards Values Conformity Assessment Body Values Conformity Assessment Path Values Country Specific Detail Type Values Country Specific Detail Values Device Allergenicity Values Device Nomenclature Values Device Sterility Indicator Values Device Type Values Device Usage Values Dosage/Pharmaceutical Form Values EC Cert Values Global Harmonization Task Force (GHTF) Class Values Global Medical Device Nomenclature (GMDN) Code Values Manufacturing Location Values Medical Device Values Product Characteristics Values Product Status Values Product Strength Unit Values Route of Administration Values Special Measure Values Sterilization Requirement Values Sterilization Values Summary of Technical Documentation (STED) Values UMDNS Code Values	Product	Last User Updated Last Changed Date	When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default Flag is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.

Data Administration Section: Project Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Project Status Values Project Type Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Publishing Requirements Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Electronic Format Requirement Attributes	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Reference Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Reference Content Value Reference Participant Values Reference Status Values Reference Type Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Registration Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
EMA Authorisation Status Values	N/A	N/A	The RMS Term Name field in the initial table view now appears as a column in the grid view.
EMA Authorization Status Values Medicinal Product Type Values Qualified Person Responsible for Pharmacovigilance (QPPV) Values Registration Status Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Sequence Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Sequence Status Values	Sequence	System Process Default Flag	When the status of an Application, Product, Product Detail Set, Event-Change Detail, and Sequence is updated as a result of running a status wizard or manually closing an event, the status set as the System Process Default Flag is used. Prior to this update, the system would randomly pick a display status to show as the status when multiple display statuses were set to the same internal system status.
Filing Type Values Sequence Status Values	Sequence	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: SPOR Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Compendial Designation/Source RMS Values	N/A	N/A	The RMS Term Name field in the initial table view now appears as a column in the grid view.
Concentration Measure Type RMS Values
Country RMS Values
Denominator Unit RMS Values
Language RMS Values
Legal Basis RMS Values
Medical Device RMS Values
Medicinal Product Type RMS Values
Procedure Type RMS Values
Route of Administration RMS Values
Unit of Measure Prefix RMS Values
ATC RMS Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Compendial Designation/Source RMS Values
Concentration Measure Type RMS Values
Country RMS Values
Denominator/Numerator Unit RMS Values
Dosage/Pharmaceutical Form RMS Values
EMA Authorisation Status RMS Values
Language RMS Values
Legal Basis RMS Values
Medical Device RMS Values
Medicinal Product Type RMS Values
Procedure Type RMS Values
Route of Administration RMS Values
Unit of Measure Prefix RMS Values
		Created By Created Date	The ability to identify by whom and when a SPOR Maintenance value was created, either via automated updates from the EMA or manually by Data Administration users. By default, this option is read-only . It is populated automatically when updates are made to the table.

Data Administration Section: Submission Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Applicant Contact Type Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Applicant Contact Values
Applicant ID Values
Application Form Type Values
Drug Registration File Documents Section Values
Drug Registration File Document Values
Font Definition Values
Leaf Status Values
PDF Properties Values
Promotional Material Audience Type Values
Promotional Material Doc Type Values
Promotional Material Type Values
Regulatory Activity Lead Values
Submission Product Type Values
Sequence Description Values
Sub Filing Type Values
Supplement Effective Date Type Values
Telephone Number Type Values

Data Administration Section: Submission Plan Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Submission Plan Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.

Data Administration Section: Task Maintenance

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Secondary Task/Sub-Task Type Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.
Task/Sub-Task Priority Values
Task/Sub-Task Status Progression Values
Task/Sub-Task Status Values
Task/Sub-Task Type Values

Data Administration Section: Workflow Management

Data Administration Table Name	Entity Affected	Field Name	Value List Description
Workflow Management Values	N/A	Last User Updated Last Changed Date	The ability to identify – and then export the results to .xls - historical audit trail data for any value in Data Administration, including when and by whom values were added. For SPOR Maintenance values, the audit trail will reflect in addition whether the values were updated from the EMA or manually by a Data Administration user.