The CTD Pyramid
Around the turn of the century, the Common Technical Document (CTD) became the standard reporting format that needs to be followed when submitting data on the quality, safety, and efficacy of a treatment for all new drug applications (NDAs). The CTD is a mandatory reporting format in the EU and Japan and is strongly recommended for NDAs submitted to the FDA in the US.
The CTD has been illustrated by means of a triangle since its inception. However, as it is a structure that contains all the necessary information for a successful submission, perhaps it would be enlightening to view it in 3D, as a pyramid.
This monumental edifice of regulatory documents is commonly constructed over a decade or more of clinical development. It is composed of a multitude of individual documents and datasets, the total size of which can typically involve the equivalent of half a million pages of text.
The CTD has a modular aspect and needs to be built on a solid foundation of well-written reports including both preclinical and clinical study reports (CSRs). Each interdependent module can be thought of as a drawer in a filing cabinet that stores the data files on a certain defined topic out of which the pyramidal dossier is built.
Successfully building such a multi-tiered structure out of what represents the culmination of so many people´s time, effort, and other investments is a colossal undertaking and one that needs a clear vision, well communicated plans, and the commitment and teamwork of many specialized players.
ICH Official Website. M4: The Common Technical Document.
Click to read [Website] (Accessed: 28 October 2019)
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