Pre-Clinical Tests

changes

  • Pre-Clinical Tests - structural change
  • Pre-Clinical Tests - narrative change

Changes to the Pre-Clinical Tests entity begin with structural changes on the application form "Corporate Entity change/Pre-Clinical Tests/structural data" based on one or more "basis for change" documents generated within the Pharmaceutical Corporation  itself or by the Business Partners and processed by the Enriched Email Client.

The required "basis for change" documents are defined in a similar fashion as they are defined for Medical Products.

The "basis for change" document(s) may originate from the corporation itself and be delivered via:

  • Enriched email message as an attached and appropriately classified document(s) or,
    if originating from other Business Partners, via:
  • Regular email message as an attached document(s). The first recipient in the corporation is responsible for the correct processing and attachment classification of such regular email message using the Enriched Email Client

Each attachment processed with the Enriched Email Client is automatically uploaded to the Corporate Documentation Cloud and has a unique ID number.

In the eCTD Integral Information System, two additional attributes are also saved, the original file name and the assigned file name. The assigned file names are automatically created taking into account the allowable path length of the Windows operating system, each Pre-Clinical Tests unique "var" synonym, and the role of the file in the eCTD context.

Since each Pre-Clinical Tests has a pre-clinical entity person as a “designated follower”, all enriched email messages/notifications related to the Pre-Clinical Tests are automatically sent to that person. 

The "basis for change" documents

The following classes of "basis for change" documents are appropriate as a basis for change for a Pre-Clinical Tests:

  • Classes of documents related to the Pre-Clinical Tests Protocol
    • Substantial Protocol Amendments as per P.I.1
      the automatically assigned file name "vpi1-pi-prop-subst-protocol-amend-pclt.pdf"
    • Non-Substantial Protocol Amendments as per P.I.2
      the automatically assigned file name "vpi2-pi-prop-non-subst-protocol-amend-pclt.pdf"
  • Classes of documents related to the Pre-Clinical Tests Finance
    • Initiative to change research organization agreement as per P.II.1
      the automatically assigned file name "vpii1-agreement-ro-amend-pclt.pdf"
    • Initiative to change statistical support agreement as per P.II.2
      the automatically assigned file name "vpii2-agreement-statistic-support-amend-pclt.pdf"
  • Classes of documents related to the Pre-Clinical Tests Facilities and Staff
    • Decision to introduce a new Investigational Site as per P.III.1
      the automatically assigned file name "vpiii1-decision-new-investig-site-pclt.pdf"

Variations

Based on the above specified "basis for change" documents, changes in the definition of a Clinical Trial initiate following Variations that have to be reported to the competent Health Authorities:

  • Variation related to the Pre-Clinical Tests Protocol
    • P.I.1 Substantial Protocol Amendment
    • T.I.2 Non-Substantial Protocol Amendment
  • Variation related to the Pre-Clinical Tests Finance
    • T.II.1 Agreement - research organization - amendment
    • T.II.2 Agreement - statistical support - amendment
  • Variation related to the Clinical Trial Facilities and Staff
    • T.III.1 Introduction of a new Investigational Site

Pre-Clinical Tests - structural change

For each Pre-Clinical Tests, a designated pre-clinical entity person is named during the entity creation process.

Only the designated pre-clinical entity person, his Assistant, or his Agent using the application form "Corporate Entity change / Pre-Clinical Tests / Structural Data"  can introduce structural changes to the Pre-Clinical Tests into the eCTD Integral Information System. Only structural changes of one Variation can be introduced at the same time.

Initiating structural change

A Corporate Entity can be changed only on the grounds of one or more "basis for change" emails having as attachments one or more "basis for change" documents defining the reasons for the upcoming change."

In the "New Change" mode of the application form using the LoV of Pre-Clinical Tests ready for change, with one or more unused "basic for change" emails, the selection of entity to be processed and structurally changed is performed. The logged-in person's roles as a designated follower, Assistant, and Agent are used as a filter to display a LoV of entities with upcoming changes.

On the same application form, in the mode "Review", it is also possible to review, with the person's clearance as a filter, all completely structurally defined Pre-Clinical Tests. In this case, changing  the structural data is not possible.

Using the dialog on the sub-application form "Correspondence" and received "basis for change" emails with attached "basis for change" documents, the designated pre-clinical entity person, his Assistant, or his Agent must determine the appropriate Variation type and start the structural definition of the change to the Pre-Clinical Tests entity.

Other non-"basis for change" emails related to the same Variation must also be identified and marked. From the LoV of possible Variations for the selected "basis for change" email combination, the appropriate Variation must be selected. If it is not certain which Variation is involved, additional "basis for change" emails with attachments must be collected to determine the appropriate Variation.

Using the "Back to form" button, a return to the main application form is made. When the change is applied and saved, a record of the selected Variation for a Pre-Clinical Tests change is inserted into the eCTD Integral Information System. At the same time:

  • a core sequence is generated and all subsequent actions of defining structural and narrative change are related to that core sequence
  • initial submission is generated
  • regulatory project person is informed via automatically generated enriched email notification

To finish the structural change short narrative "Description of the change" must be done using "Before" and "After" write boxes.

Completing the structural change

The structural change process can be completed in two ways:

  1. In one session when all changed structural data describing one Variation/change are defined
  2. in several sessions where
    1. in the first session appropriate Variation and some of the changed data are defined
    2. in the  next session(s) when additional emails related to the Variation are marked and remaining additional changed data are defined

Additional sessions can be performed In the "Unfinished Change" mode of the application form using the LoV of Pre-Clinical Tests with selected appropriate Variation and unfinished change of data. The logged-in person's roles as a designated pre-clinical person, Assistant, and Agent are used as a filter to display a LoV of entities with unfinished changes.

At the end of each session, the question "Is the structural change of the entity complete?" is automatically prompted and if the answer is positive, structural change is completed, the entity is is removed from the LoV of entities with un unfinished change and assigned the status "completely structurally changed".

If the response is negative, the entity can be selected again using the option "Unfinished changes" when the LoV of entities with unfinished changes is displayed.

Pre-Clinical Tests - narrative change

At the insertion of a Pre-Clinical Tests change record into the eCTD Integral Information System a directory tree structure of project initial submission documents and basic for change documents is automatically created.

For project initial submission documents replacement documents marked with (*) are created. 

Replacement documents of already acquired basis for change documents are automatically substituted and marked with (#) and only missing basis for change documents are marked with (*).

Only the designated pre-clinical entity person, his Assistant, or his Agent can change entity definition documents and upload them to the Corporate Documentation Cloud using the application form "Corporate Entity change / Pre-Clinical Tests / Narrative Data".

The designated pre-clinical entity person, his Assistant, or his Agent have to:

  • Obtain all required basis for change documents from the relevant Organizations
  • Make necessary changes to the entity definition documents that have already been submitted to the Business Partner(s) and upload them to the Corporate Documentation Cloud

The local pre-clinical project person, his Assistant, or his Agent  have to:

  • Create project initial submission documents and upload them to the Corporate Documentation Cloud

Project initial submission documents are uploaded using the application form "Projects / Upload Submission Documents" from the "Corporate Projects - Pre-Clinical Tests" application module.

When the designated pre-clinical entity person, his Assistant, or his Agent  declares that the entity narrative change definition is complete, an automatically generated enriched email notification(s) is sent to the pre-clinical project person(s) so that the initial submission(s) can be submitted to the Business Partner(s).