Leaf titles are an important part of eCTD submissions, but they are rarely considered outside of Regulatory Operations. While authors tend to focus on what their file is called, reviewers look at leaf titles, not file names. Putting meaningful information into leaf titles makes submissions easier to navigate, and makes reviewers’ jobs easier.
Tag Archive: study reports
eCTD Leaf Titles
Study Report Formats
The eCTD allows companies to submit clinical and nonclinical study reports in either legacy or granular format. The legacy format requires assembly of all sections of the report into one document, while the granular format allows each section of the report to stand as a separate document. Most companies submit clinical reports (in m5) using the granular format and nonclinical reports (in m4) using the legacy format. The granular format makes it easier to publish clinical study reports, but it requires planning and coordination between Medical Writing and Regulatory Publishing to achieve those efficiencies.