The CDISC Standard for the Exchange of Nonclinical Data (SEND) provides the structure and implementation rules for the submission of computer readable datasets. SEND is one of the required standards for data submission to the U.S. Food and Drug Administration (FDA) and specifies a way to collect and present nonclinical data in a consistent format. The overall package consists of several components, but the focus is on individual study endpoint data which are typically mapped to datasets in domains with several variables in each study dataset.
Japan’s Pharmaceutical and Medical Devices Agency (PMDA), one of the earliest adopters of eCTD, adheres to a number of unique business rules which create a unique implementation of the eCTD specifications. Information available on eCTD best practices is also limited for this region, primarily due to lower levels of submission activity. What do we already know about submitting eCTDs in Japan and what can we expect later this decade as they implement eCTD v4.0?
In the scheme of a large submission such as an original New Drug Application (NDA), the accompanying Structured Product Label (SPL) is often an afterthought. Small in scope should not be confused for simple – the SPL ranks as the most complex piece of your submission. The SPL standard is based on extensible markup language (XML), and the intricacies of this format are difficult to grasp. If you are unfamiliar with XML the probability...
Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.
Study Tagging Files XML is a very common area of confusion for most people new to eCTD and XML in general. I have spent a lot of time creating the XML for sequences by hand, and have examined sponsors’ XML to determine the location of the error. Because of these experiences, I thought it would be beneficial to discuss the basic structure of the index.xml, stf.xml, and the single most common question I receive related to the STF which is, “Why am I seeing errors 1952, 1953 and are these the same error?”