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eCTD Editor – guide through the program

Creating, updating, deleting and finding a preparation

Creating a preparation

First, you need to create a preparation for which you will be creating documentation – a submission . To start, you need to click on this icon:

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  • Enter the product’s name. The program will verify if you have used allowed characters.
  • Press OK. A new product will appear in the product chart just below the toolbar.
  • Click on the relevant line. Data on sequences of the selected product will display in the tree in the left part of the screen. The product is new, therefore the tree includes only the name of the product, see the image.
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Changing the product’s name

The preparation can be renamed if no submission has been generated and if you have selected its name in the tree on the left. The form with the cell for its name is displayed in the right part of the Properties panel.

Deleting a preparation

A preparation may be deleted only if no submission has been generated. To delete it use this icon:

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Before deleting a preparation, the program will require your confirmation.

Finding a preparation

In the left part of the screen there is the “My Content” panel, which is implicitly hidden. When the user clicks the vertical button “My Content”, several clickable components appear:

  • Products with unsent submission – this command will find products with at least one unsent submission in their sequence
  • All products – will find all products

The search result is displayed in a chart. Records on products in the chart can be sorted by different columns. Users can also create filters.

Generating directory structure and its adjustment

New submission

When you select the name of a product in the tree, you can add further submissions to the sequence of submissions using the icon with an envelope.

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The program numbers submissions as prescribed by relevant specifications: 0000, 0001, ...

Deleting a submission

If the relevant submission is selected in the tree and if it is the last submission of a given preparation and no output has been generated for such submission, the following icon in the menu is accessible and the submission can be deleted.

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Before deleting a submission the program will require your confirmation.

Adding directory structure M2-M5

If an item with submission number is selected in the tree and if the submission does not include the directory structure of M2-M5 modules yet, relevant folders prescribed by specifications may be used. To do this, use this icon

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tagged M2-M5.

Adding M1-EU directory structure

If the “M1” item is selected in the tree and if the submission does not include the directory structure of M1-EU module, relevant folders prescribed by specifications may be used. To do this, use this icon

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tagged M1-EU.

When clicking this icon, the program will ask for the first country for which the submission will be created so that it can adjust for that country. Folders for other countries may be added later.

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Adding a new folder

In certain places of the hierarchic structure the technical specification allows adding a new folder. If the user selects in the directory structure a folder enabling creation of a new subfolder, the relevant icon in the menu is allowed:

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The program automatically completes the added folder with the hierarchy prescribed by specifications, if the added folder is supposed to include such additional hierarchy.

Updating folder attributes

In case of some folders the specifications prescribe the user the duty to edit attributes. Cells for updating the attribute values are available in the Properties panel. See, e.g., folder in the “32p-drug-prod” folder:

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Deleting a folder

If the user selected in the tree a folder creatable by the user and if the given submission has not been exported yet, the folder can be removed with this icon:

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Uploading documents, their update, sequences

Uploading a document

If the user selects a folder which can, according to the specifications, include new documents and if there is a document that can be uploaded and no submission has been generated, you can upload a new document using this icon:

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The following figure shows a dialogue window for uploading a new document into the first submission in the sequence of submissions. The window in this case does not resolve relationship to documents from previous submissions in the sequence. It is also the most simple case where there are no attributes recorded about the document

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What do the following cells mean?

  • Element type - The roll-up window contains a list of possible elements enabling the user to upload a new document into folders. Every type of xml element includes help information from the specifications.
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  • Operation - When the user creates first submission, the only possible action is “new”. In other cases also “append”, “replace”, “delete”. When the user selects “append”, “replace”, “delete”, the dialogue will display also documents from previous submissions that can be – according to the type of action and selected type of element - used.:
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  • Modified File - A list of documents from previous submissions which, in accordance with the specification logic, are offered on the basis of their submission number and the selected type of element. The program ensures that a document that was removed in the previous submission could not be replaced in the following submission, etc. The “File” attribute includes a reference and enables users to open a relevant document from the previous submission so that users are absolutely certain which document they are going to modify.
  • File - It enables to upload one document into a submission. The document can be selected with the Browse button. The program enables to upload only documents allowed by the specification and types of documents that the program can convert into allowed formats, namely:
    • doc
    • docx
    • pdf
    • jpeg
    • xml
    • png
    • svg
    • gif

The application also enables to upload files whose names do not meet the specification criteria, however, the program immediately tries to correct their names and presents new names to the user for further correction.

This is beneficial especially in the case when registration documents are prepared by an external supplier who does not know about restrictions applying to documents in the eCTD format. In the figure below you can see how the program changed the original name into a formally correct one and presents it to the user for further correction.

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  • File Name - The name under which the uploaded document will be saved. The file name extension cannot be changed.
  • Other attributes (Substance, Manufacturer, ...) - In case of some documents the specification prescribes the duty to record further data. Without providing values of the attributes the document cannot be saved.
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Values of these attributes can be updated later on as long as the submission has not been generated. All you need to do is to select the relevant document record. The form for doing this is in the Properties panel. See the figure.

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Updating an uploaded document.

If the submission has not been exported yet, the content of uploaded documents can be updated. Even when users run the application in a web browser, all they need to do is to double-click the record of the relevant document. It will open in a relevant editor, for instance in MS WORD. When users save documents opened in this way, changes are saved right in the system. Therefore, there is no need to reupload the document back into the system in a complicated way.

eCTD Editor is a network application. More users can use it at the same time. If one user is working with the document, his colleague cannot open the document in the regime for saving changes. MS Word will display a warning that the document is locked and it can only be opened in the reading mode. The waiting user can be informed when the document is available in the mode for making changes again.

Deleting a file

If no submission has been generated yet, the document can be removed with this icon as long as it has been selected in the directory folder panel.

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Before making the action, the program will require user’s confirmation.

Administrating EU Envelope data

Adding a new envelope

If the user selects in the directory structure the EU folder, the program will display in the Properties window a form for adding new envelopes:

ECTD Editor EU Envelope

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If the user clicks the Add Envelope button, the program will add a record of one envelope and will display a form for data update.

Updating the data on an envelope

The form for data update is visible only when the record EU envelope has been selected in the tab.

ECTD Editor EU Envelope

Click on the image to enlarge.

The form displays help from the last version of the specification. The user does not have to search for the relevant help. The roll-up windows include comments for every selection.

ECTD Editor EU Envelope

Click on the image to enlarge.

Some cells enable to insert several values (Invented Names, Inns, Tracking). To add values into the list, use the Add button. To remove them use the Remove button. The Remove button is only available if you have selected the item you wish to delete.

You can create multiple envelopes corresponding to the number of countries. You can save them all at once by pressing the OK button. The program will mark those cells that have been filled incorrectly with red colour and will describe the error.

ECTD Editor EU Envelope error

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Submission validity check, export

Submission validity check

The program checks almost all specification rules of an eCTD submission at the moment when it is being created. However, as not all these rules can be checked immediately, it is necessary to carry out a final validation of each submission.

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The resulting validation protocol looks like this:

ECTD Editor Validation

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It is not necessary to search for errors in the list of all criteria. All you need to do is to use the Show Errors Only button:

ECTD Editor Validation

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The reason for this error was a missing Cover Letter document. After appending it, the submission can be sent to the regulatory authority.

ECTD Editor Validation

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Generating output

If the version is suitable, the submission can be generated using this icon:

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The program starts conversion of MS Word documents into the pdf format. The user is informed about the progress of the conversion. The program then records the generated documentation and offers it to the user to download it. After downloading, the archive needs to be unwrapped again and burnt on a CD or DVD, provided with a required tag in accordance with the prescription of the local regulatory authority and filed.

Deleting generated output

Once the output has been generated, the submission cannot be changed. That is the reason why it is possible to delete the output, make changes and generate the submission again. You can delete export of the submission using this icon:

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