Creating Corporate Entities 

tenth step

There is one class of Corporate Entities whose structural definition can be initiated/completed in the tenth step of the process of creating a hierarchy of corporate entities:

  • Medicinal Product track

    • Clinical Trials Dossier/First - Clinical Trial - Innovative Investigational Medicinal Product Project - initiated automatically and automatically structurally completed/launched

For one Corporate Entities class, the structural definition can be initiated and completed in this step.

To initiate the structural definition of a Corporate Entity  in the tenth step, the appropriate "basis for creation"  type of document must be sent to the relevant corporate entity person via Enriched Email and the lower-level Corporate Entities required for the "minimal data set" must be previously completely structurally defined.

Whenever a Corporate Entity is fully structurally defined, an enriched email notification is sent to the appropriate corporate entity person designated to define the related higher-level Corporate Entity with information that one of the prerequisites for the complete structural definition is provided.

The narrative definition can begin as soon as the "minimal data set" is inserted in the eCTD Integral Information System Database because an appropriate directory tree with replacement documents is created in that instance . The narrative definition can be performed until the first initial submission  to the relevant Health Authorities and/or business Partners.

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Clinical Trial Dossier/First Clinical Trial - Innovative Investigational Medicinal Product Project

automatically initiated and structurally completed/launched

The Clinical Trial Dossier contains all the data on the realization of Clinical Trial Projects for a particular Innovative Active Substance in one State/Country.

The automatic creation of a Clinical Trial Dossier entity in the eCTD Integral Information System is announced/notified with a "basis for creation"  type of document sent to the top-level clinical entity person via Enriched Email as a:

  • Enriched email automatic notification with
    • Topic - "New Dossier/Dossier Extension - Clinical Trials"
    • Subtopic - "Introduction of a New Dossier/Dossier Extension - Clinical Trials"
    • Subject - "The announcement/notification on the creation of a Clinical Trial Dossier"
    • Initiator - enriched email that was used as a basis for creation of the first Clinical Trial entity

sent when the first Clinical Trial entity for a Innovative Active Substance is completely structurally defined.

In order to preserve the entity creation chain of correspondence, this enriched email announcement/notification is automatically checked as read.

Clinical Trial Dossier/First Clinical Trial-IIMP - structural definition

Clinical Trial Dossier(s) is automatically created and opened when the first Clinical Trial of an Active substance is completely structurally defined.  The structural definition process is performed automatically using Clinical Trial data. At that time Clinical Trial Project(s) is also launched. If the Clinical Trial is conducted at Investigational Sites in several countries, for each country a Clinical Trial Dossier is created and a Clinical Trial Project is launched.

The following lower-level Corporate Entities and structural data, used to define first Clinical Trial entity, are utilized to structurally define the Clinical Trial Dossier and launch the first Clinical Trial Project:

  • Clinical Trial Dossier
    • Innovative Active substance of the Dossier
      previously defined global/basic Corporate Entity
    • Dossier project type
    • State/Country
  • Clinical Trial Project
    • Clinical Trial entity
      previously defined sixth level Corporate Entity
    • Organization(s) participating in the project
      • Sponsor
      • Investigational Institution(s)
        previously defined global/basic Corporate Entity(s)
    • clinical project person responsible for the conduct of the project

The next Clinical Trial Projects are treated as an extensions of the Clinical Trial Dossier.

When the record is inserted into the eCTD Integral Information System a core sequence is generated and all subsequent structural and narrative definition actions and conduct of the Clinical Trial Project are associated with that sequence.  

Clinical Trial Dossier/First Clinical Trial-IIMP - narrative definition

The Clinical Trial Dossier does not require narrative documents for its definition.

At the Corporate Project launch, using the appropriate clinical trial initial submission documents template, the initial submission directory tree with initial submission replacement documents and entity definition documents is automatically generated.

Narrative definition of a Clinical Trial Project consists of creation and upload of initial submission documents required by the clinical trial initial submission documents template. Upload of initial submission documents for all types of "active" Corporate Projects can be done using "Corporate Projects/Submission documents - upload" application form.