Pre-Clinical Tests - creation

  • Gathering of the documentation/data
  • Structural definition
  • Narrative definition

The creation of a new Pre-Clinical Tests begins with a "basis for creation" regular/enriched email message/notification with the topic "New Pre-Clinical Tests":

  • enriched email notification after the creation of the Active Substance, whose proposed legal basis for future marketing authorization is in accordance with Article 8(3)
  • regular/enriched email message sent when there is a need for additional Pre-Clinical Tests for an Innovative Active Substance, Generic Active Substance, novel excipients and non-novel non-compendial excipients

Gathering of the documentation/data

Gathering of documentation and necessary data for the structural and narrative definition of a new Pre-Clinical Tests can be done in advance, before the beginning of structural definition and subsequently when the Pre-Clinical Tests has become a topic in the enriched email correspondence.

Before the beginning of the structural definition

Gathering of documentation related to the creation of a new Pre-Clinical Tests is a process that can begin before the receipt of the "basis for creation" enriched email and subsequent beginning of the structural definition. During that period database record for the new Pre-Clinical Tests and directory tree of replacement files does not exists in the eCTD Integral Information System and the only topic that can be used in the registered correspondence is "New Pre-Clinical Tests". Attached documents are classified and uploaded to the Corporate Documentation Cloud but they are not linked with the Pre-Clinical Tests that is being created. Nevertheless, linking of all correspondence to the newly created Pre-Clinical Tests essential and it can be done when the structural definition is started.

After the beginning of the structural definition

The pre-clinical entity person begins the process of  Pre-Clinical Tests structural definition right after receiving the "basis for creation" enriched email. When selecting a "basis for creation" enriched email on the "correspondence" sub-application form, all related correspondence previously received relating to the Pre-Clinical Tests being created should also be selected.

During the insertion of the record into the eCTD Integral Information System a core sequence and a directory tree of replacement narrative files are generated and the newly defined Pre-Clinical Tests automatically becomes the topic of the "basis for creation" enriched email and all selected previously received enriched emails. That can be seen when inserting additional data on the "correspondence" sub-application form.

Previously received attachments/documents have to be manually assigned to the corresponding replacement files using the application form "Corporate Entity creation / Pre-Clinical Tests / Narrative data". The process is explained in the narrative definition section.

All correspondence from then on should be conducted using enriched email messages and the newly-introduced Pre-Clinical Tests as the topic.

During the subsequent correspondence and classification of the attachment(s), attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement files.

Structural definition

In order to create and structurally define a Pre-Clinical Tests following business processes must be performed in the presented order:

  1. Generation/receipt of a "basis for creation" regular/enriched email
  2. Selection of one "basis for creation" enriched email message/notification and related correspondence on the sub-application form "Correspondence" of the application form "Corporate Entity creation / Pre-Clinical Tests / Structural Data"
  3. Definition of Pre-Clinical Tests general structural data 
  4. Definition of Pre-Clinical Tests Objectives and selection of Investigational Sites
  5. Definition of Pre-Clinical Tests Design and Marketed Substance Production Chain(s)
  6. Completion of the structural definition 
    1. Complete structural definition during the first instance/session
    2. Complete structural definition in several instances/sessions

1. Generation/receipt of a "basis for creation" regular/enriched email

The enriched email notification automatically sent to the high-level pre-clinical entity person after the creation and complete structural definition of the Active Substance with the intended legal basis for marketing authorization in accordance with Article 8(3).

The regular/enriched email message with the attachment "Decision to introduce a new Pre-Clinical Tests" sent by a corporate person with the appropriate authority to the high-level pre-clinical entity person when there is a need for additional Pre-Clinical Tests. The regular email message must be registered by the recipient.

If necessary, additional correspondence using the same topic and subtopic can be made in order to clarify certain details. When all details are clarified, the structural definition process can be started by choosing the menu item "Corporate Entity creation / Pre-Clinical Tests / Structural Data" on the "Corporate Entities" application module.

2. Selection of one "basis for creation" enriched email message/notification

To create a new Pre-Clinical Tests, first, using the "Correspondence" sub-application form, a received "basis for creation" enriched email relevant to the new Pre-Clinical Tests being created must be selected from the non-processed correspondence documents. In addition, all enriched email messages classified as "related correspondence" pertaining to the same new Pre-Clinical Tests should also be selected in order to properly establish entity creation correspondence environment.

3. Definition of Pre-Clinical Tests general structural data 

A minimal set of structural data is specified with the (*) and they are a prerequisite for the insertion of the record in the Integral Information System Database.

The Pre-Clinical Test's structural data is defined by using:

  • selection block for type of Pre-Clinical Tests
    • Toxicology
    • Pharmacokinetics
    • Pharmacology
  • Active Substance - transferred from the "basis for creation" enriched notification/message
  • Sponsor(s) - selected form the LoV of corporate Organizations
  •  Tests classification - selected from the LoV for selected type
  • Protocol (number and version) - free text field 
  • Security classification - selected from the LoV
    • public
    • internal
    • confidential
    • restricted
  • Designated pre-clinical entity person - selected form the LoV of persons with corresponding security clearance
  • Central contact person - selected form the LoV of persons with corresponding security clearance
  • Official title - free text field
  • Indication - selected from the LoV in accordance with ICD-10 classification

4. Definition of Pre-Clinical Tests Objectives and selection of Investigational Sites

Objectives

In the free text field several objectives can be defined of three types:

  • primary
  • secondary
  • safety

Several Investigational Sites can be selected from the LoV of Organizations of the  appropriate type.

Other involved Organizations, such as:

  • Contract Research Organizations
  • Medicinal Product Providers
  • Equipment Providers
  • etc.

can be selected from the LoV of Organizations of the appropriate role type.

5. Definition of Pre-Clinical Tests Design and Marketed Substance Production Chain(s)

Pre-Clinical Tests design

The Pre-Clinical Test's design can be defined by using selection blocs to specify:

  • Route of administration
  • Tests design
  • Age range
  • Species of animals

Free text field is provided for internal comment.

Marketed Substance Production Chain(s)

Several Marketed Substance Production Chains can be selected from the LoV of Marketed Substance production Chains.

When the minimal structural data set criterion is met and the Pre-Clinical Tests entity is introduced into the eCTD Integral Information System a core sequence, directory tree of replacement narrative files, and a enriched email notification to the designated pre-clinical entity person are generated.

At the same time, the Pre-Clinical Tests Project is initiated by the automatic compilation of the initial submission, and the pre-clinical project person is notified with an automatically generated registered email notification to prepare and upload the initial submission project documents.

The files that will be generated at the end of the Pre-Clinical Tests are marked with an "F" and do not prevent the initial submission from being submitted to the Investigational Sites.

During subsequent correspondence and classification of attachment, the attached document(s) are automatically uploaded to the Corporate Documentation Cloud and assigned to the appropriate replacement narrative file(s).

6.Completion of the structural definition

The structural definition process can be completed in two ways:

  1. In one session when all structural data are defined
  2. in several sessions where
    1. in the first session only minimal data set and maybe some of the additional data are defined
    2. in the  next session(s) where remaining additional data are defined

Upon completion of the structural definition process, the Pre-Clinical Tests is assigned the status "completely structurally defined". 

At that point, an automatically generated enriched email notification is sent to top-level pre-clinical entity person with the information that a Pre-Clinical Tests Dossier or Dossier extension is created.

6.1 Complete structural definition during the first session

The minimal data set denoted with (*) is prerequisite for the insertion of the record into the eCTD Integral information System.

If the minimal data set requirement is met, then confirmation of the complete structural definition is prompted. If the complete structural definition is confirmed the record is inserted into the database of the eCTD Integral Information System with the status "completely structurally defined" with the ability to be used to define corporate entities of the higher level.

6.2 Complete structural definition in several sessions

In the first session only the minimal data set and maybe some additional data are defined. At the end of the session, confirmation of the complete structural definition is prompted. If the answer is negative, the record is inserted and the status of the entity is set to "incompletely structurally defined". 

Additional data can be added on the same application form by clicking on the "Additional data" button and selecting the required Pre-Clinical Tests from the LoV of incompletely defined Pre-Clinical Tests. Previous enriched emails related to the selected Pre-Clinical Tests can be seen on the "correspondence" sub-application form.

The structural definition is completed when a positive response is given to the prompt for a complete structural definition. The Pre-Clinical Tests is assigned the status "completely structurally defined" with the ability to be used to define corporate entities of the higher level.

Narrative definition

The designated pre-clinical entity person is responsible for the complete narrative definition of the Pre-Clinical Tests.

The eCTD documents can be either:

  • created by the designated pre-clinical entity person and manually uploaded to the Corporate Documentation Cloud or
  • collected from related Business Partners via email correspondence and automatically uploaded to the Corporate Documentation Cloud during the enriched email processing of the Business Partner's regular email messages. 

Therefore, to narratively define a Pre-Clinical Tests following business processes must be performed:

  1. Creation of eCTD documents and manual uploading to the Corporate Documentation Cloud
    and/or
  2. Collection of eCTD documents via email correspondence and automatic uploading to the Corporate Documentation Cloud
  3. Completion of the process

1. Creation of eCTD documents and manual uploading to the Corporate Documentation Cloud

Using any regular text processor eCTD documents have to be created and pdf files generated for uploading to the Corporate Documentation Cloud. If required, a verification process by a senior manager can be included upon request.

The process is initiated by choosing the menu item "Corporate Entity creation / Pre-Clinical Tests / Narrative Data" on the "Corporate Entities" application module.

Other than that, the process is same as described in the "Substance - creation" page of this site, here.

2. Collection of eCTD documents via email and automatic uploading to the Corporate Documentation Cloud

In case the eCTD documents were originally generated by the Business Partner, they can be obtained via email correspondence. During the processing of such a Business Partner's regular email message by the Enriched Email and using the email attachments classification, attachments are automatically uploaded to the Corporate Documentation Cloud.

The process is same as described in the "Substance - creation" page of this site, here.

3. Completion of the process

When all the presented replacement files in the directory tree are replaced with written eCTD files, the process ends automatically and the Pre-Clinical Tests entity is set to be "completely structurally and narratively defined".