Hyperlinking Impact on the Critical Path to eCTD Submission Deadline

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This is Part 2 of a larger article on hyperlinking best practices. To read Part 1, Hyperlinking: Making the Most of Navigation in eCTD Submissions, click here

Regulatory operations is frequently asked about submission turnaround time once the final document is delivered. The strategies around how documents are authored will often have an impact on accurately answering this question.

When authors are writing submission documents and highlighting text for publishers to link to, they could consider asking themselves “Does adding a hyperlink to this destination add value to the review?” For example, an ISS will likely mention all clinical study reports contained in the eCTD application in a general context. When a specific table, listing, figure, section or appendix of a CSR is referenced, adding a link to that destination will assist the reviewer in quickly locating the supportive information. When the reference is non-specific and blue text is added at each mention of a particular clinical study, the overall publishing time for that file may be greater than what was initially anticipated in order to complete all publishing and QC, as well as resolve any issues that may arise if there is a typo in text.

Part 1 – Hyperlinking – Making the Most of Navigation in eCTD Submissions

Another issue sometimes encountered on the critical path involves multiple deliverables.

Regulatory operations ability to complete publishing on multiple deliverables is contingent upon creating a hyperlink to a section of a document that has yet to be delivered. If many references are made throughout the application to a document that is on the critical path, the likely impact is an increased amount of publishing and QC work to be completed after that critical path deliverable is provided for publishing.

Ideally, once the submission is on the critical path, publishing is focused purely on completing those deliverables and all other submission components have already been through the publishing, QC, and sponsor acceptance stage. The goal is to have as few tasks to complete as possible as the submission date nears. Planning to this end will ensure the shortest turnaround time between when the final submission component is received and when the submission is transmitted to the Agency.

Author: Emily Onkka

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