A common Technical Document (CTD) is the mandatory format for applications in the EU and Japan, and the strongly recommended format of choice for applications submitted in the United States. The CTD provides a structure and format for presenting the data in an application, including summaries and detailed study reports. Its purpose is to assemble all the quality, safety, and efficacy information in a common format.
The CTD is organized into 5 modules. Module 1 is region specific, containing administrative information and prescribing information, while Modules 2 to 5 are intended to be common for all regions. Module 2 contains the general introduction to the drug, the overviews, and the summaries. Foundational information for this material is contained in the other modules: the quality information in Module 3; the Nonclinical Study Reports in Module 4; and the Clinical Study Reports and raw data (where applicable) in Module 5.
The CTD includes 2 high-level clinical summaries in Module 2: the Clinical Overview, a relatively short document that provides a critical assessment of the clinical data; and the Clinical Summary, a longer document that focuses on data summarization and integration. The basis for these clinical summaries is the clinical documentation in Module 5. The clinical information typically forms the bulk of the application, besides nonclinical and quality information. Medical writing support is most frequently requested for these clinical parts.
Medical Writers can be responsible for the authoring of one or more documents within the CTD, or for the oversight of one or more parts of the CTD. This oversight role is best performed by an experienced Medical Writer as this requires a thorough understanding of the requirements and an awareness of the challenges during the development process.