It’s hard for most people to grasp important eCTD concepts like lifecycle and granularity until they’ve seen them in action. The best way I’ve found to teach these concepts is by using an eCTD viewer. There are a number of viewers on the market, ranging from free desktop applications to large scale web-based viewers. While I have my favorites, any of them will serve to educate authors, project teams, and Regulatory staff about granularity and document lifecycles. I’m not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help your company successfully adopt the eCTD.
Tag Archive: STF
The Importance of eCTD Viewers
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.