Ennov InSight Administration 7.1

Data Administration Functions by Module

Data Administration provides the ability to manage the functions available in your system according to your Ennov InSight license modules. The following table shows the Data Administration values that should be considered based on the Ennov InSight components you use.

Application Maintenance

Registrations Assemblies Publishing
Selection RPT PDM SPT RDA ELP PRP
Age Span Population Values
Application Category Values
Application Status Values
Application Type Values
Chief Investigator 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
Sponsor Type Values
Trial Design Values
Trial Phase Values
Trial Scope Values
Trial Subject Groups Values

Assembly

Assemblies Publishing
Selection SPT RDA ELP PRP
Assembly Category Values
Assembly DTD/Schema Types
Assembly Status Values
Assembly Subcategory Values

Assembly Variables

Publishing
Selection ELP PRP
Assembly Repository Variables
Assembly System-Defined Variables
Assembly User-Defined Variables
Ennov InSight Assembly Variables

Change Maintenance

Registrations
Selection RPT
Change Type Values
Event-Change Details Status Values

Custom Lists Maintenance

Registrations Assemblies
Selection RPT PDM SPT RDA
Custom List Names
Custom List Values
Assemblies Publishing
Selection SPT RDA ELP PRP
Bind to Label Values
Bind to Status Values

Event Maintenance

Registrations Assemblies Publishing
Selection RPT PDM SPT RDA ELP PRP
Action Type Values
EU Grouping or Worksharing Values
Timeline/Event Plan Values
Event Status Values
Event Type Values
PSUR Report Code Values
Secondary Event Type Values

Notifications

Registrations Assemblies
Selection RPT PDM SPT RDA
Notification Specifications
Notifications

Other

Registrations Assemblies Publishing
Selection RPT PDM SPT RDA ELP PRP
Attachment Values
Concentration Measure Type Values
Denominator Unit Values
Entity XML/UI Mappings
Home Page Display Properties
Indications/Intended Use Values
Language Values
Legal Basis Values
Length Unit Of Measure Values
MAH/Development Sponsor/Organization 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
Note: E-signature functionality is an optional feature for Ennov InSight that requires special setup and configuration. Contact Client Enablement to enable E-signatures for your Ennov InSight version.
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

Product Detail Set Maintenance

Registrations
Selection RPT PDM
Color Values
Compendial Designation/Source Values
Dose Frequency Values
Substance Role Values
Genetically Modified Cell Origin Species Values
Human Consumption Product Values
Label Type Values
Manufacturer Function Values
Manufacturer Values
Manufacturer Type Values
Material Type Values
Medical Device Party Code Values
Packaging Category Values
Packaging Type Values
Product Bio Type 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
Somatic Cell Therapy Cell Type Values
Somatic Cell Therapy Origin Species Values
Somatic Cell Therapy Origins Values
Source of Scientific Advice Values
Species Values
Storage Condition Values
Time Unit Values
Type of Dossier Submitted Values
Type of Gene Therapy Transfer Product Values
Type of Gene Therapy Values
Type of Genetically Modified Cell Origin Values
Volume Unit Of Measure Values

Product Family Maintenance

Registrations Assemblies Publishing
Selection RPT PDM SPT RDA ELP PRP
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

Product Maintenance

Registrations
Selection RPT PDM
Applicable Standards Values
Conformity Assessment Path Values
Device Allergenicity Values
Device Nomenclature Values
Device Sterility Indicator Values
Device Type Values
Device Usage Values
Dosage/Pharmaceutical Form Values
EC Cert Values
EU Classification Rule Values
EU Class Values
FDA Device Class Values
FDA Regulation Number Values
Global Harmonization Task Force (GHTF) Class 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

Project Maintenance

Registrations Assemblies
Selection RPT PDM SPT RDA
Project Status Values
Project Type Values

Reference Maintenance

Registrations Assemblies
Selection RPT PDM SPT RDA
Reference Content Values
Reference Participant Values
Reference Status Values
Reference Type Values

Registration Maintenance

Registrations
Selection RPT PDM
EMA Authorization Status Values
Medicinal Product Type Values
Qualified Person Responsible for Pharmacovigilance (QPPV) Values
Registration Status Values

Sequence Maintenance

Registrations Assemblies Publishing
Selection RPT PDM SPT RDA ELP PRP
Filing Type Values
Sequence Status Values

SPOR Maintenance

Registrations
Selection RPT PDM
ATC RMS Values
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 Value
Procedure Type RMS Values
Route of Administration RMS Values
Unit of Measure Prefix RMS Values

Submission Maintenance

Publishing
Selection ELP PRP
Applicant Contact Type Values
Applicant Contact Values
Applicant ID Values
Application Form Type Values
Font Definition Values
PDF Property Values
Promotional Material Audience Type Values
Promotional Material Doc Type Values
Promotional Material Type Values
Regulatory Activity Lead Values
Sequence Description Values
Sub Filing Type Values
Supplement Effective Date Type Values
Telephone Number Type Values

Submission Plan Maintenance

Assemblies Publishing
Selection SPT RDA ELP PRP
Submission Plan Status Values

Task Maintenance

Registrations Assemblies
Selection RPT PDM SPT RDA
Secondary Task/Sub-Task Type Values
Task/Sub-Task Priority Values
Task/Sub-Task Status Progression Values
Task/Sub-Task Status Values
Task/Sub-Task Type Values