License Modules: eCTD Publishing
| Subfeature | Subfeature Description | License Modules |
|---|---|---|
| eCTD publishing assembly features and functions | Create eCTD and electronic output, specify assembly-level publishing options for eCTD, links, and variables, change element types to specify leaf-specific publishing properties, request generated published output (eCTD and electronic). | Electronic Lifecycle Publishing |
| Electronic hyperlinks | Create, retarget, and set channel and settings on hyperlinks. |
|
| Reference leaf elements | Create leaf elements to reference other leaf elements with querying on referenced leaf elements for a specific submission. |
|
| eCTD import and merge | Import one or multiple eCTD sequences; merge eCTD sequences. | Electronic Lifecycle Publishing |
| Create eCTD wizard | Create or update an eCTD sequence. | Electronic Lifecycle Publishing |
| Bulk eCTD Wizard | Migrate multiple eCTD submissions to Calyx RIM from another system in a supported document management system (DMS). | Electronic Lifecycle Publishing |
| Create Study Reports wizard | Add study reports to an eCTD sequence. | Electronic Lifecycle Publishing |
| Create Submission Plan Wizard | Create a submission plan and associate entities such as applications, events, and sequences to the submission plan. |
|
Related information
- License Modules: Product Families, Clinical Trial Shared Data
- License Modules: Products, Pharmaceutical Products
- License Modules: Registrations, Full Product Presentations, Registration FPP Attachments and FPP Previous EV Codes
- License Modules: Registration Attachment
- License Modules: Applications
- License Modules: Comparators
- License Modules: Events
- License Modules: Sequences
- License Modules: Product Detail Sets (PDS)
- License Modules: Assembly Types
- License Modules: Activity Workflow
- License Modules: Projects
- License Modules: Tasks, Notifications, and References
- License Modules: Change, Change Details
- License Modules: Reports
- License Modules: Approval Management
- License Modules: Submittal Management and Lifecycle
- License Modules: General Assembly
- License Modules: Planning and Tracking
- License Modules: Review and Approval
- License Modules: Document Analysis
- License Modules: General Publishing
- License Modules: Paper Publishing
- License Modules: Administration
- Calyx RIM License Modules