eCTD Validation Criteria v3.0 (which will come into force September of this year) states that:
“The applicant should make every effort to address these areas [failure to comply with best practice criteria] before the eCTD is submitted to the agency. The applicant should be prepared to include justification for any Best Practice criteria not met in the submission cover letter/reviewer's guide.”
The best practice criteria address some of the link formatting issues which any eCTD publisher will face. These will be addressed in the sections which follow.
When to link
The use of links within and between documents submitted in eCTD format is an important consideration for any submission publisher. There is no absolute rule set in stone which determines how many links should be created in any document, but the eCTD spec. v3.2.2 states that:
“Hypertext links throughout the document to support annotations, related sections, references, appendices, tables, or figures that are not located on the same page are helpful and improve navigation efficiency.”
The purpose of hypertext links, then, is to help the reviewer navigate through and between documents, and so this should always be in the mind of the publisher. Links to sections on the same page, for example, might not help the reviewer at all, and so such linking is merely an unnecessary waste of time.
Link Properties
The properties associated with any link are governed by the eCTD validation criteria v3.0 and the eCTD specifications v3.2.2. They are as follows:
| 16.BP2 | PDF Files | Hyperlinks within documents, or between documents within the same sequence, have a valid target |
This means that each link in any PDF included as part of an eCTD submission (a single sequence) must open to a valid document, or section within a document, within that sequence. A link must not be broken. For example, if the name of a document within the eCTD changes, all links (if not corrected) directing to that particular document will break.
| 16.BP4 | PDF Files | Hyperlinks to targets within documents in a different sequence in the same application have a valid target |
As above, but this refers to links to documents which are located within a different eCTD submission belonging to the same application (i.e. with a different eCTD sequence number).
| 16.BP9 | PDF Files | All PDF hyperlinks are relative |
A link will be relative if its path recognises only the folders and files which are included in the overall eCTD structure. If the link path contains the drive name and folders which sit outside the eCTD structure, the link will break. This is because the drive and folder setup outside the eCTD folder structure will be specific to your computer, and so the agency’s computer will not be able to follow the same path.
For example:
If a link appears as follows: ..\..\..\m1\eu\10-cover\emea\emea-cover-lou then its path relates only to those folders included within the overall submission structure. It is therefore a relative link.
If however, the link path is: Mark\Submissions\calcium\0002\m1\eu\10-cover\emea\emea-cover-lou then it relates to folders (namely “Mark” and “Submissions”) which sit outside of the overall eCTD structure, and so the link will not work on the agency’s computer. This link is said to be “absolute”.
| 16.BP6 | PDF Files | All bookmarks and links are set to "inherit zoom" |
The “inherit zoom” property means that when the link is used, the reviewer’s view settings (i.e. the page zoom level) for the PDF document will not change. Some settings will change how the PDF is viewed, which could slow the reviewing process.
Link Appearance
The eCTD specifications state that a link may appear either with a thin line appearing around the text, or with the link text turned to blue:
Blue text should be used where the document has been created in a Word Processing tool such as MS Word and rendered to PDF. A thin line should be used where this is not possible, for example where a scanned document is being included in a submission (although scanned documents should undergo OCR, it may still not be possible to change the link text to blue).
Adobe Acrobat will let you change properties of document links, however there are numerous Adobe Acrobat third party plug-ins which will enable your submission publishers to change the properties of hyperlinks within eCTD submission documents by batch. Such applications will save hours of document publishing time. Some eCTD publishing tools will also automatically change such properties (and other document properties, e.g. document open properties) when publishing the eCTD.
If you would like any advice choosing the right software for your needs, please feel free to visit our website at www.apexregulatory.co.uk and contact us by phone or using our contact form and we’ll be glad to help.
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