When authors generate documents intended for electronic submission they use blue-colored font to indicate where a hyperlink should be added to allow the reviewer to easily access the cross-referenced information. Hyperlinks guide the reviewer closer to the source data or supportive information cited in the body of a document. There are a few industry standards with regards to hyperlinking in submissions.
Generally, when a cross reference with the same destination is repeated multiple times on the same page, only the first mention of the destination is hyperlinked per page. Also, when the cross reference and destination are on the same page, there is no need to hyperlink the cross-referenced text.
Consistently formatting documents with designated styles for headings, table and figure captions, and utilizing the “Insert Cross-reference” feature in Microsoft Word facilitates the publishing process. When the “Insert Cross-reference” feature is used, these references are automatically updated as the document evolves, and hyperlinks are created when the document is rendered to PDF. The “Insert Cross-reference” feature improves the overall quality and accuracy of cross references that have destinations within the same document. Hyperlinks that have destinations within the originating document are referred to as intra-document hyperlinks. Publishers will complete any finishing touches to these documents to ensure high-quality bookmarks and hyperlinks. Documents are subsequently added to the submission to complete the inter-document linking, enhancing navigation by adding hyperlinks to cross-referenced text that points to destinations located outside of that document.
Inter-document linking continues to be somewhat of a manual process. There are ways to automate the process, such as keyword linking tools that allow publishers to associate specific text with an individual destination and link each instance of the keyword within a particular file or set of files. There are also common terms that publishers can search for such as “see” or “refer to” to identify text typically precedes a hyperlink. A publisher may also perform a search for instances of blue text and link accordingly.
These are a few examples of methods publishers use to identify where links should be made, or are commonly found within submission documents. Once the linking is performed, the publisher then must go through each page to ensure all blue text is actively linked. Once all text is linked, the accuracy of link destinations is subject to a 100% accuracy QC review, followed by another overall QC release phase. These steps are necessary to ensure overall consistency and quality of the published eCTD submission.
There are some common issues found in submission documents that can cause delays in completing publishing of submission deliverables without obtaining feedback from content owners. Some issues include:
- Documents containing blue text to generate a hyperlink that has a destination at a folder level rather than at a file level. Hyperlinks must have a file-level destination in order to generate a hyperlink.
- Ambiguous destinations based on wording of the cross reference. For example, Module 1.6.3, Correspondence Regarding Meetings typically contains multiple files in a marketing application.
Based on the wording of the referenced text, the destination file each hyperlink should point to may not be apparent to the publisher. Whenever possible, it is helpful for the leaf title to appear in the document as the blue text to be linked to in order to reduce ambiguity of which file to link to within a particular section of the submission that does not have structured content on what it should contain.
Lastly, there are times where the cross-referenced text refers to sections or tables that may not be correct or present within the destination document. When this occurs, the publisher may be able to identify where the link should be directed, and would then open an issue for the content owner to ensure this assumption is correct and provide the content owner the option to revise the document, ensure the destination of the hyperlink is correct, or provide further guidance on where the link should be directed.
