Data Administration Selection Lists
Data Administration Selection Lists: Application Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Age Span Population Values | Clinical Trial Application Form |
| Application Category Values | Ennov Defined: Best Practices |
| Application Status Values | Ennov Defined: Best Practices |
| Application Type Values |
Regulatory Agency Guidance (US: application-type.xml v1.1) Regulatory Agency Defined (CN: http://www.nmpa.gov.cn/WS04/CL2042/) (WHO: Product-Type.xml) |
| Chief Investigator Values | Client Defined |
| Country Values | ICH Website: 2 digit ISO Codes |
| CTA Product Role Values | Ennov Defined: Best Practices |
| Legal Status Values | FDA Website; EMA Defined |
| MedDRA Term Values | Client Defined |
| Medical Condition Investigated Values | Client Defined |
Ennov InSight Administration 7.3 Access Data Administrator Functions
| Selection List Entity | Source for Values |
| Procedure Type Values (per Country) | XEVMPD Controlled Vocabularies - Authorisation Procedures Ennov Defined: Best Practices |
| Reason for Premature Ending Values | Clinical Trial Application Form |
| Region Values | Client Defined |
| Region Type Values | Client Defined |
| Sponsor Type Values | Client Defined |
| Trial Design Values | Clinical Trial Application Form |
| Trial Phase Values | Clinical Trial Application Form |
| Trial Scope Values | Clinical Trial Application Form |
| Trial Subject Groups Values | Clinical Trial Application Form |
Data Administration Selection Lists: Assembly
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Assembly Category Values | Ennov Defined: Best Practices |
| Assembly DTD/Schema Type Values | Ennov Defined: Based on current agency guidance |
| Assembly Status Values | Ennov Defined: Best Practices |
| Assembly Subcategory Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: Assembly Variables
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Assembly Repository Variables | Client Defined, examples provided |
| Assembly System Defined Variables | Ennov Defined: Best Practices |
| Assembly User Defined Variables | Client Defined |
| Ennov InSight Assembly Variables | Ennov Defined: Best Practices |
Data Administration Selection Lists: Change Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Change Type Values | Client Defined |
| Event-Change Detail Status Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: Custom Lists Maintenance
Data Administration Selection Lists: Custom Lists Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Custom List Names | Client Defined |
| Custom List Values | Client Defined |
Data Administration Selection Lists: DMS Integration
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Bind to Label Values | Client Defined |
| Bind to Status Values | Client Defined |
| Rendition Identifier Values | Client Defined |
Data Administration Selection Lists: eCTD 4.0 Submission Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| CV Profile Values | Regulatory Agency Defined |
| Sender-defined Keyword Values | Client Defined |
Data Administration Selection Lists: Event Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Action Type Values | Client Defined |
| EU Grouping or Worksharing Values | Ennov Defined: Best Practices |
| Event Status Values | Ennov Defined: Best Practices |
| Event Type Values | Ennov Defined: Best Practices |
| PSUR Report Code Values | EMA Defined |
| Secondary Event Type Values | Ennov Defined: Best Practices |
| Timeline/Event Plan Type Values | Ennov Defined: Best Practices |
| Timeline/Event Plan Values | Client Defined |
Data Administration Selection Lists: Notifications
| Selection List Entity | Source for Values |
| Notification Specifications | Client Defined |
| Notifications | Client Defined |
Data Administration Selection Lists: Other
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Concentration Measure Type Values | XEVMPD Controlled Vocabularies - Concentration Types |
| Denominator Unit Values | XEVMPD Controlled Vocabularies – Units of Measurement and Units of Presentation |
| Entity XML/UI Mappings | Ennov Defined: Best Practices |
| Home Page Display Properties | Client Defined |
| Indications/Intended Use Values | Client Defined |
| Language Values | The two-letter language code ISO 639-1:2002 Alpha-2 code is assigned to the language. The default value is set to Active. The standard set of extra fields can be configured for this value. |
| Selection List Entity | Source for Values |
| Legal Basis Values | XEVMPD Controlled Vocabularies – Legal Basis |
| Length Unit of Measure Values | Client Defined |
| MAH/Development Sponsor/Organisation Values | XEVMPD Controlled Vocabularies - Organisations |
| Master File Location (MFL) Values | Client Defined |
| Message Sender Values | Client Defined |
| Numerator Unit Values |
XEVMPD Controlled Vocabularies – Units of Measurement |
| Previous EV Code Values | Client Defined |
| Quantity Unit of Measure Values | Client Defined |
| Reason for E-Signature Values | Client Defined |
| Reason for Termination/ Withdrawal Values | Client Defined |
| SME Status Values | XEVMPD Controlled Vocabularies - SME Status |
| Sub-Indication Values | Client Defined |
| System Alert Type Values | Client Defined |
| Unit of Measure Prefix Values |
XEVMPD Controlled Vocabularies – Units of Measurement |
| Unit of Presentation Values | Client Defined |
| Weight Unit of Measure Values | Client Defined |
Data Administration Selection Lists: Product Detail Set Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Color Values | Client Defined |
| Compendial Designation/Source Values | XEVMPD Controlled Vocabularies - Reference Sources |
| Dose Frequency Values | Client Defined |
| Substance Role Values | Client Defined |
| Genetically Modified Cell Origin Species Values | Client Defined |
| Human Consumption Product Values | Client Defined |
| Selection List Entity | Source for Values |
| Label Type Values | Client Defined |
| Manufacturer Values | Client Defined |
| Manufacturing Functions Values | Client Defined |
| Material Type Values | Client Defined |
| Material Values | Client Defined |
| Medical Device Part Code Values | Client Defined |
| Packaging Category Values | Ennov Defined: Best Practices |
| Packaging Type Values | Client Defined |
| Product Bio Type Values | Client Defined |
| Product Detail Set Status Values | Ennov Defined: Best Practices |
| Product Material Values | Client Defined |
| Production Type Values | Client Defined |
| QC Status Values | Client Defined |
| Shape Values | Client Defined |
| Shelf Life Category Values | Client Defined |
| Shelf Life Type Values | Client Defined |
| Somatic Cell Therapy Cell Types Values | Client Defined |
| Somatic Cell Therapy Origin Species Values | Client Defined |
| Somatic Cell Therapy Origins Values | Client Defined |
| Source of Scientific Advice Values | Clinical Trial Application form |
| Species Values | Client Defined |
| Storage Condition Values | Client Defined |
| Substance Type Values | Ennov Defined: Best Practices |
| Time Unit Values | Ennov Defined: Best Practices |
| Type of Dossier Submitted Values | Clinical Trial Application form |
| Type of Gene Therapy Transfer Product Values | Clinical Trial Application form |
| Type of Gene Therapy Values | Clinical Trial Application form |
| Type of Genetically Modified Cell Origin Values | Clinical Trial Application form |
| Volume Unit of Measure Values | Client Defined |
Data Administration Selection Lists: Product Family Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| ATC Values | XEVMPD Controlled Vocabularies - Anatomical Therapeutic Chemical (ATC) Code Addition |
| Division Values | FDA |
| Product Family Status Values | Ennov Defined: Best Practices |
| Product Family Values | Client Defined |
| Substance Attachment Values | Client Defined |
| Substance Class Values | XEVMPD Controlled Vocabularies – Substance Classes |
| Substance Values | XEVMPD Controlled Vocabularies – Substances |
| Therapeutic Area Values | CDER Website |
| Therapeutic Class Values | FDA Website |
| Trade Name Values | Client Defined |
Data Administration Selection Lists: Product Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Applicable Standards Values | Client Defined |
| Conformity Assessment Body Values | Client Defined |
| Conformity Assessment Path Values | Ennov Defined: Best Practices |
| Device Allergenicity Values | Client Defined |
| Device Classification Values | FDA; EMA |
| Device Nomenclature Values | Client Defined |
| Device Sterility Indicator Values | Client Defined |
| Device Type Values | Client Defined |
| Device Usage Values | Client Defined |
| Dosage/Pharmaceutical Form Values | XEVMPD Controlled Vocabularies – Pharmaceutical Dose Forms |
| Selection List Entity | Source for Values |
| EC Cert Values | Client Defined |
| EU Classification Rule Values | EMA |
| FDA Regulation Number Values | FDA |
| Global Harmonization Task Force (GHTF) Class Values | GHTF |
| Manufacturing Location Values | Client Defined |
| Medical Device Values | XEVMPD Controlled Vocabularies – Medical Devices |
| Product Characteristics Values | Client Defined |
| Product Status Values | Ennov Defined: Best Practices |
| Product Strength Unit Values | Client Defined |
| Route of Administration Values | XEVMPD Controlled Vocabularies - Routes of Administration |
| Special Measure Values | Client Defined |
| Sterilization Requirement Values | Client Defined |
| Sterilization Values | Client Defined |
| Summary of Technical Documentation (STED) Values | Client Defined |
Data Administration Selection Lists: Project Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Project Status Values | Client Defined |
| Project Type Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: Publishing Requirements Maintenance
This section of Data Administration is not currently used.
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Electronic Format Requirement Values | Not currently used |
Data Administration Selection Lists: Reference
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Reference Content Values | Client Defined |
| Reference Participant Values | Client Defined |
| Reference Status Values | Client Defined |
| Reference Type Values | Client Defined |
Data Administration Selection Lists: Registration Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| EMA Authorisation Status Values | XEVMPD Controlled Vocabularies – Authorisation Status |
| Medicinal Product Type Values | XEVMPD Controlled Vocabularies – Medicinal Product Types |
|
Qualified Person Responsible for Pharmacovigilance (QPPV) Values |
EMA Agency |
| Registration Status Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: Sequence Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Filing Type Values |
Regulatory Agency Guidance (US: submission-type.xml V1.1) (AU: sequence-type.xml) (WHO: Application-Type.xml) Ennov Defined: based on Regulatory Guidance |
| Selection List Entity | Source for Values |
| Sequence Status Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: SPOR Master Lists
| Selection List Entity | Source for Values |
| ATC RMS Values | EMA Agency - SPOR System Referentials List: Anatomical Therapeutic Chemical Classification System |
| Compendial Designation/Source RMS Values | EMA Agency - SPOR System Referentials List: Source of Information |
| Concentration Measure Type RMS Values | EMA Agency - SPOR System Referentials List: Units of Measurement Type |
| Country RMS Values | EMA Agency - SPOR System Referentials List: Country |
| Denominator/Numerator Unit RMS Values |
EMA Agency - SPOR System Referentials List: Units of Measurement |
| Dosage/Pharmaceutical Form RMS Values | EMA Agency - SPOR System Referentials List: Combined Pharmaceutical Dose Form |
| EMA Authorisation Status RMS Values | EMA Agency - SPOR System Referentials List: Authorisation Status |
| Language RMS Values | EMA Agency - SPOR System Referentials List: Language |
| Legal Basis RMS Values | EMA Agency - SPOR System Referentials List: Application Legal Basis |
| Medical Device RMS Values | EMA Agency - SPOR System Referentials List: XEVMPD Medical Device |
| Medicinal Product Type RMS Value | EMA Agency - SPOR System Referentials List: XEVMPD Medicinal Product Type |
| Procedure Type RMS Values | EMA Agency - SPOR System Referentials List: EU Regulatory Authorisation Procedure |
| Route of Administration RMS Values | EMA Agency - SPOR System Referentials List: Routes and Methods of Authorisation |
| Unit of Measure Prefix RMS Values | EMA Agency - SPOR System Referentials List: Units of Measurement Prefix |
Data Administration Selection Lists: Submission Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Applicant Contact Type Values |
Regulatory Agency Defined |
| Applicant Contact Values | Client Defined |
| Applicant ID Values | Client Defined |
| Application Form Type Values | Regulatory Agency Defined (US: form-type.xml V1.4) |
| Font Definition Values | Ennov Defined: based on Ennov InSight Rendering default configuration |
| Leaf Status Values | Ennov Defined: Best Practices |
| PDF Property Values | Client Defined |
| Promotional Material Audience Type Values |
Regulatory Agency Defined |
| Promotional Material Doc Type Values |
Regulatory Agency Defined |
| Promotional Material Type Values |
Regulatory Agency Defined |
| Regulatory Activity Lead Values |
Regulatory Agency Defined (AU: reg-activity-lead.xml) (WHO: Submission-Unit-Type.xml) |
| Sequence Description Values |
Regulatory Agency Defined (AU: sequence-description.xml) |
| Submission Product Type Values |
Regulatory Agency Defined (CN:) (WHO: Product-Sub-Type.xml) |
| Selection List Entity | Source for Values |
| Sub Filing Type Values |
Regulatory Agency Defined (US: submission-sub-type.xml V1.1) (CN:) http://www.nmpa.gov.cn/WS04/CL2042/ (WHO: Application-Sub-Type.xml) |
| Supplement Effective Date Type Values |
Regulatory Agency Defined |
| Telephone Number Type Values |
Regulatory Agency Defined |
Data Administration Selection Lists: Submission Plan Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Submission Plan Status Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: Task Maintenance
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Secondary Task/Sub-Task Type Values | Client Defined |
| Task/Sub-Task Priority Values | Ennov Defined: Best Practices |
| Task/Sub-Task Status Progression Values | Client Defined |
| Task/Sub-Task Status Values | Ennov Defined: Best Practices |
| Task/Sub-Task Type Values | Ennov Defined: Best Practices |
Data Administration Selection Lists: Workflow Management
The following table identifies the selection lists (drop-down lists and multi-select boxes) in Ennov InSight . Some of these lists will be populated with values when shipped with the software. For those lists, the table identifies where the values were obtained.
| Selection List Entity | Source for Values |
| Workflow Management | Client Defined |