eSubmission Builder - Online help

Introduction

This is the online help for the ECPA eSubmission builder. It is available from within the builder as well as standalone document on the ECPA eSubmission website

This online help will explain the main features and concepts of the different panes in a concise mode. It is intended that the application is self-explanatory after a short phase of self-based study for any user that is familiar with standard web applications as well as with dossier creation. Please also note the available demo video on Youtube (see Further available information and help)

Please note that the current first version is for testing purposes. The next release in Q3 / 2020 is planned for productive use.

Dossiers - Repository

A dossier (or better: dossier project) consists of multiple dossier versions, sharing the same basic ToC, regulatory type and application type that is being selected from the beginning.

The dossier repository lists all dossier in the system. With the menu bar on top you can do the following actions:

  • Create new dossier project
  • Edit dossier project metadata until it is not in a "frozen" state - when "frozen" you can view the metadata
  • Delete a dossier project
  • Import an existing CADDY-xml dossier (with all versions)

Dossier creation

When creating a dossier you need to provide the following metadata:

  • You must provide your own Project Id and title for identification
  • The Table of Content (ToC) can be either the provided ToC templates (currently only one template avaiable) or you can create the dossier project without predefined ToC structure; in order to create a ToC yourself.
  • The regulatory type and application type for the dossier must be provided. The respective picklists for those fields are "open"  (see the open lock icon) which means that you can either select a picklist value or you can type in your own value

Edit / view dossier project

You can change the dossier metadata, until a dossier is in frozen state. This is the case when you have published and submitted the first dossier version and have set the first dossier version to the state "Frozen" (see below). From this point on, the metadata becomes immutable for all dossier versions of this dossier project and you can view the metadata only.

Delete a dossier project

You can delete a dossier project, including all dossier versions and publications. Handle with care!

Please note that the documents that are linked to the dossier versions are not deleted by this operation.

Import CADDY-xml dossier

An existing CADDY-xml dossier (with version 03.06.00 or later) can be imported in the eSubmission builder. On the dialog click on the button "Select submission file" and select any caddy.xml file of a version of the project.

The underlying regulatory action can be continued by creating new dossier versions. The imported versions cannot be modified, as they are considered to be already submitted. Imported versions can also be exported in GHSTS format, using the eSubmission builder as a "cross-compiler".

CADDY-xml is not strict with respect to many metadata fields and does not use concepts of the eSubmission builder (e.g. document family), so the import works on a best guess approach and may not work completely as implicitly expected. The internal metamodel contains more information as contained in CADDY-xml, so it is normal that not all metadata fields are filled after import.

Dossier - Versions

In this pane the available dossier version for the selected dossier (in the pane above) are displayed. Intially after creation of a dossier project this pane is empty, the first version has to be created explicitly. When you have selected a ToC template in the dossier project attributes, the first version will be created from this ToC template.

The version number of the dossier version is assigned automatically, only the attribute "version title" has to be supplied.

Each dossier version is in one of the following state (see the icon in the first column)

  • Editable - initial state after creation and during dossier version editing
  • Locked - when the version is made immutable to generate a test publication
  • Frozen - when the version is considered ready for submission and the final publication can be generated

For a selected dossier version the following operations are available:

  • New version - available for the very first version and when the last dossier version is selected and in state frozen
  • Edit version - when the dossier version is in state editable
  • Delete version - when the dossier version is in state editable

A new dossier version V2, V3 etc. is a copy of the preceding dossier version, including ToC with document assignments, product / substance & composition as well as sender / recipient information. In the new dossier version you can then modify the information. However, you cannot modify all information freely, due to lifecycle restrictions based in the underlying publication standards. The explanation of those constraints is outside the scope of this online help.

Dossier - Details

This pane displays the metadata of the selected dossier version and its parent dossier project.

Dependent on the state of the dossier version (see above) the information on this pane (only the version title) is editable or not.

Dossier - Product / Substance

In the upper part of this pane the assigned product of the currently selected dossier version is displayed / can be selected.

The product can be one of the entry from the repository of products and its components which is embedded in the lower area. If the required repository entry is not yet part of the repository you can add it directly from this screen.

In case of a creation of a sustance dossier, a product entry with 100% composition of the active substance is to be created first as dummy product entry, and then selected here.

Dossier - Sender / Recipient

In the upper part of this pane you can select the sender and recipient information for the selected dossier version, by selecting an entry from the repository of legal entities and then clicking the button to add the respective entry as sender or recipient.

If the required repository entry is not yet part of the repository you can add it directly from this screen.

Dossier - Table of Content

In this pane the following ToC node related tasks can be done:

  • ToC Node manipulation (when dossier version is in editable
    • Create / Edit / Move / Delete ToC Node
  • Change ToC display
    • Expand / Collapse
  • Navigate in ToC (Node down / Node up)
  • Filter ToC
    • Search in ToC / Hide empty node

Dossier - ToC Node Document Assignment

The lower right pane (also called "Node window") shows the document that are currently assigned to the selected ToC node.

Above the Node window, the document repository is displayed. To assign a document version to a ToC node, please select a document version from the document repository and click the Button "Add selected document version to ToC node". Inversely, there is a button to remove the assigned document. Further buttons allow to move the position of the document in the document list.

Due to lifecycle constraints not all operations on documents are possible at all times:

A document that has been submitted in a (frozen) previous version

  • cannot change its relative position
  • cannot be removed from the node, but only set to "Retired" - which indicates that the document has been previously submitted but is now considered logically delete

Each ToC node can have only one member of a document family assigned, not many. A member of a document family can be replaced with another member of the same family. Please see the concept of document family for more details.

Publications

Dossier & Publications -  Lifecycle

For a selected dossier version, the publications can be managed on this pane.

Dossier versions are in one of the three states:

  • Editable
  • Locked
  • Frozen

In order to publish a dossier version, its state has to be promoted from Editable to "Locked" state first. This is required in order to generate a stable baseline with information for subequent operations (e.g. lifecycle information).

To do so, click on the "Lock" button. Then, the Locked block is highlighted - showing the lock timestamp - and the pane below to generate the publication formats is activated.

Dossier & Publications - Publication Formats

Publications can be generated when the selected dossier version is in status "Locked" or "Frozen". The available publication formats are

Please note that not all information that is captured in the eSubmission builder will be published in each publication format, as the data models of the two standard differ.

When changing from status "Editable" to status "Locked", the grid with the two publication formats CADDY-xml and GHSTS is activated, allowing to trigger test publications for final quality checking. Those test publications made in state "Locked" are not intended for submission and do contain the remark "Do not submit" in the publication.

After quality check, you can then promote the dossier version to its final "Frozen" status. Then, please regenerate the publications from this state and submit the results to the recipient.

It is by intention that there is no possibility to revert the status change from Frozen to Locked or Editable, so please use with care.

When the publications have been generated they can be opened and viewed directly with the eSubmission viewer, also available from the ECPA site at https://esubmission.ecpa.eu/esub-viewer. For a tight integration download this viewer first and make sure that the eSubmission Viewer path is correctly present in the administration perspective.

Documents

Documents - Repository

The document repository shows all available document families.

A document family is a concept to group related document versions that represent the same core information in variations, either versions over time (e.g. a version of a study report and another version of an amended study report), variations in the rendition (e.g. sanitized and non-sanitized version, different layouting styles of the same information) or variations in language (e.g. different translations of the same information).

Hence, the document family concept

  • avoids a proliferation of individual items in a repository
  • is the underlying prerequisite of lifecycle operations of type "replace": In A document version can only be replaced by another member of the same document family in a ToC node, not by a member from another document family.

A document family should not be used to group different document types that may change differently over time. E.g. a study report and its associated study summary may change differently; an updated study summary may reflect new scientific insights for the same original study report. Generally speaking, a document family is grouping ony documents of the same document type.

When creating a new document family, the metadata

  • document family ID
  • document family title

has to be provided that is inherited to all members of the document family.

The two metadata fields of a document family can be

  • created
  • edited - when any document family version it is not part of a locked or frozen dossier version
  • deleted - when any document family version it is not part of a locked or frozen dossier version

Document - Versions

A document version can be

  • created from scratch
  • copied from another version
  • edited - when it in status editable, not in status frozen
  • deleted - when it is in status editable, not in status frozen

A document version can be in status editable and status frozen. A document version will be changed automatically to status frozen when is is part of a dossier version that is changed to status "locked" or "frozen". This is done to avoid that document version are changed that have been already submitted, thereby destroying the tracability of changes.

Each document is displayed in the document version pane with its status and the metadata

  • version tag - this information can be freely assigned to add meaningful tags to variations (e.g. 1.0-Sanitized, 1.0-NonSanitized, 1.0-English)
  • version title - the title of the document version

Please note that the version title and the document family title are independent metadata fields.

Document - Details

This pane shows the metadata and the content references for the selected document version.

  • The "Main File" contains a reference to the core PDF representation of the content of the document version. The Main file is mandatory, as well as its PDF format. More precisely, the format should be PDF/A-1b, which is not enforced by the builder.
  • Each document version can optionally have additional attachments in arbitrary format, e.g. the associated Word file for the PDF Main representation.

Document - PDF preview

The main PDF file can be viewed, navigated, downloaded and printed in the document file viewer which is part of the eSubmission builder. Dependent on the web browser used, the functionality of the PDF file viewer may vary slightly.

Reference data

The term "reference data" applies to legal entities, products and their composition, picklists and their values, and finally ToC templates.

Legal Entities

The legal entity repository lists all legal entities, which are all companies or authorities you want to use in the role of a sender or recipient of a dossier.

Legal Entity - Details

The details page allows you to manage the metadata of a legal entity. You can optionally one or many contact persons for each legal entity.

Products

The products repository lists the products that can be attached to a dossier.

Product - Details

The details page allows you to manage the metadata of a product, including its composition.

Product - Composition

The composition of a product can be managed in this section. Please note that the addition of a specific new component requires that this component is being selected in the lower part of the screen.

Components

The component repository shows the components that can be used in compositions of products. The term "component" is a generalized term for substance, as components may be of type "substance" or "organism".

Component - Details

This pane shows the available metadata for a component. You can add identifiers to better describe the component, e.g. using a CAS number.

Table of Contents

The table of Contents (or ToC) is the hierarchical node structure representing the regulatory (data) requirements of the dossiers. A ToC node can have one to many assigned documents - and inversely a document can be assigned to many nodes as well, if it fulfuills multiple regulatory requirements.

A ToC template is the hierarchical structure designated to be reused across multiple dossier projects that need to adhere those regulatory requirements represented by the ToC.

In the test release there is currently only one available ToC templace which is the OECD template from 2006. Currently ToC templates cannot be imported or modified.

Management functionality to import / modify / version ToC templates are easy to extend, because a similar functionality is present for dossiers already.

Table of Contents - Details

The pane shows the metadata of the ToC template, as well as its structure.

The information is currently immutable.

Picklists

The picklists manage the values that can be used in controlled fields. The values provided here are taken from the definition of the OECD GHSTS standard.

When using picklists for the metadata of the different entities, there are two types of picklists:

  • open (with an open lock) - the user can decide to type in a different value than provided by the underlying picklist. The provided new value for the entity is not added as new picklist value in the picklist.
  • closed (with a closed lock) - the user can only select one of the provided picklist values

The picklist values itself are currently immutable. This is partly due to the fact the the values for closed picklists are a core feature of the publications standards and cannot be changed by end users in any case.

For the other values there is currently no possibility to manage the picklist values, but those picklists are usually "open" picklists where new values can be added adhoc when the picklist is being used in the metadata of an entity.

Misc

Administration

This pane offers functionality that is mostly required for beta testing only.

  • You can clear the database to reset the application in its initial start and start from scratch - use with care!
  • You can create dossiers for different test scenarios
  • You can provide / change the path for the eSubmission viewer, used for viewing the published dossiers

Glossary