Creating Corporate Entities

sixth step

There are three classes of Corporate Entities whose structural definition can be initiated/completed in the sixth step of the process of creating a hierarchy of corporate entities:

  • Medicinal Product track

    • Clinical Trial Dossier/First Clinical Trial - Generic Investigational Medicinal Product Project - fifth level entity - initiated automatically and automatically structurally completed/launched
    • Clinical Trial - Innovative Investigational Medicinal Product(s) - seventh level entity - initiated by decision and structurally incomplete

    • Marketing Campaign - OTC Medicinal Product(s) - fifth level entity - initiated automatically and structurally completed

For one Corporate Entities class, the structural definition is initiated but not completed in this step.

For the two classes of Corporate Entities, the structural definition is initiated and completed in this step.

For the three classes of Corporate Entities, the narrative definition is initiated in this step by the automatic creation of the appropriate directory structures with the replacement documents.

To initiate the structural definition of a Corporate Entity  in the sixth 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 automatic 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 initiation and complete structural definition of a Corporate Entity can be done on the appropriate application form for New Corporate Entity Creation.

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.

info@iqnet.uk

Add comment

Comments

There are no comments yet.

Clinical Trial Dossier/First Clinical Trial - Generic 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 Generic 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 Generic 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-GIMP - 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
    • Generic 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 Database 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.  

Structural data of Clinical Trial Dossier are used during the generation of initial submission for Marketing Authorization Application Project.

Clinical Trial Dossier/First Clinical Trial-GIMP - 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.

Clinical Trial with Innovative Investigational MP(s)

initiated by decision and structurally incomplete

To enable the use of Clinical Trials with an Innovative Investigational Medicinal Product(s) as a topic in Enriched Email correspondence as soon as possible, their creation is initiated in the sixth step of Corporate Entities definition.

The creation of a Clinical Trial with an Innovative Investigational Medicinal Product(s) entity in the eCTD Integral Information System is instigated with a "basis for creation"  type of document sent to the top-level clinical entity person via Enriched Email:

  •   Enriched email message with:
    • Topic - "New Clinical Trial"
    • Subtopic - "Introduction of a New Clinical Trial"
    • Subject - "The decision to introduce a new Clinical Trial with Innovative Investigational Medicinal Products" 
    • Attachment - "Decision document"
      Details and justification for such a business move together with the required projected resources must be provided in this document and should be signed by a corporate person with the appropriate authority

sent when the results of previous Pre-Clinical Tests and Clinical Trials justify the initiation of a new Clinical Trial with Innovative Investigational Medicinal Products

The top-level clinical entity person can choose to initiate the definition process themselves or to forward the email to one of their subordinate colleagues taking into account the required professional skills and security classification of the meter in question.

    This enriched email is displayed on the sub-application form "Correspondence" on the “Corporate Entity creation/Clinical Trial-Innovative IMP/Structural Data” application form. To preserve the entity creation chain of correspondence, this enriched email must be checked, and after returning to the main application form, the process of structural definition can begin.

    Clinical Trial with Innovative Investigational MP(s) - structural definition

    Since a Clinical Trial with Innovative Investigational MP is completely defined by the following Corporate Entities and the structural data:

    • Active Substance
      previously defined global/basic Corporate Entity
    • Organization(s) 
      previously defined global/basic Corporate Entity performing:
      • sponsorship
      • realization of clinical trial
      • monitoring
      • statistical support
      • ...
    • clinical entity person responsible
    • Trial type
      defined by health legislation
    • Reports from previous Pre-Clinical Tests
    • Reports from previous Clinical Trials
    • Innovative Investigational Medicinal Product
      previously defined first level Corporate Entity defined
    • Innovative Investigational MP-Preparation Production Chain
      previously defined third level Corporate Entity

    its structural definition process is done in two parts. In the sixth step of creating a hierarchy of Corporate Entities only the first part of the structural definition can be done when global/basic entities, Innovative Active Substance and Organization are completely structurally defined and the results from the previous Pre-Clinical Tests and Clinical Trials are available.

    Structural definition - first part

    The minimal set of structural data, based only on the global/basic Corporate Entities, is specified with the (*) on the application form "New Corporate Entity/Clinical Trial/Structural Data" and they are a prerequisite for the insertion of the record into the eCTD Integral Information System Database.

    The record contains following minimal set of structural data:

    • Innovative Active Substance
    • Lead Sponsor - Organization
    • Study Classification
    • Clinical entity person responsible
    • Official Title
    • Indication(s)
    • Objective(s)
    • Trial Type and Phase

    When the record is inserted into the eCTD Integral Information System a core sequence is automatically generated and all subsequent narrative definition actions are associated with that sequence. The designated clinical entity person is informed of the new assignment through an automatically generated enriched email notification. Also, at the same time, the topic of the "basis for creation" enriched email is replaced with the newly created Clinical Trial and the designated clinical entity person is set as a "designated follower" of all enriched email messages related to the newly introduced Clinical Trial. 

    The "designated follower" is responsible for the complete structural definition and subsequent structural changes and is automatically granted the necessary system privileges with the ability to delegate the assigned rights to an Assistant or Agent using the features of the Enriched Email Client.

    Since an enriched email message is used as a “basis for creation”, using the business rules for this situation, the entity creation chain of correspondence is established and the initiating enriched email is inserted into the “basis for creation” enriched email message.

    During the definition of the minimal set of the structural data of the Clinical Trial, an editable unique "var" abbreviation "cltiimp" is automatically generated which is later used as a part of the template directory paths and documents names. 

    Innovative Investigational Medicinal Product(s)

    For the realization of a Clinical Trial one or more Innovative Investigational Medicinal Products are required. 

    By clicking on the "Investigational MP" button, a "basis for creation " enriched email notification, with the requested dosage form and strength, is sent to the top- level cmc entity person for creating one Innovative Investigational Medicinal Product. The record is inserted into the eCTD Integral Information System Database, the entity creation correspondence chain is maintained and the structural definition of the Innovative Investigational Medicinal Product is initiated.

    The structural definition can be done on the "New Corporate Entity/Medicinal Product/Structural Data - Innovative IMP" application form.

    The instigation of the creation of the Innovative Investigational Medicinal Products completes the first part of the structural definition of Clinical Trial. The Clinical Trial entity is assigned the status "incompletely defined".

    Clinical Trial with Innovative Investigational MP(s) - narrative definition

    When the Clinical Trial record is inserted in the eCTD Integral Information System Database, directory structure with replacement files annotated with (*) is automatically created.

    Designated clinical entity person responsible for the creation and upload of the narrative files is informed about its new assignment via an automatically generated enriched email automatic notification. This person, responsible for uploading newly generated files, is also responsible for their subsequent changes, and is automatically granted the necessary system privileges. New or changed files are uploaded using the application form "New Corporate Entity/Clinical Trial/Narrative Data".

    Detailed description of the narrative definition process is presented here

    When all replacement documents are replaced with newly created narrative documents, status of the new Clinical Trial entity is set to “completely defined - draft”.

    At that point, an automatically generated enriched email notification is sent to the top-level clinical entity person with the information that the newly Clinical Trial has been completely defined.

    Marketing Campaign - OTC Medicinal Product(s)

    Under development

     

    Marketing Campaign - OTC Medicinal Product(s) - structural definition

    Under development

    Marketing Campaign - OTC Medicinal Product(s) - narrative definition

    Under development